{"id":"cyklokapron","rwe":[],"_fda":{"id":"5dece4b5-d95e-4fe7-b0ed-89bd573f2fad","set_id":"00630e54-0e84-465d-96a5-63486c87dcd9","openfda":{"nui":["N0000175634","N0000175632"],"unii":["6T84R30KC1"],"route":["INTRAVENOUS"],"rxcui":["238720"],"spl_id":["5dece4b5-d95e-4fe7-b0ed-89bd573f2fad"],"brand_name":["tranexamic acid"],"spl_set_id":["00630e54-0e84-465d-96a5-63486c87dcd9"],"package_ndc":["83634-401-41","83634-401-10"],"product_ndc":["83634-401"],"generic_name":["TRANEXAMIC ACID"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_pe":["Decreased Fibrinolysis [PE]"],"substance_name":["TRANEXAMIC ACID"],"pharm_class_epc":["Antifibrinolytic Agent [EPC]"],"manufacturer_name":["Avenacy, Inc."],"application_number":["ANDA203521"],"is_original_packager":[true]},"version":"1","pregnancy":["8.1 Pregnancy Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see Data ) . Reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. Doses examined were multiples of up to 3 times (mouse), 6 times (rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively (see Data ) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. It is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. For decisions regarding the use of tranexamic acid injection during pregnancy, the potential risk of tranexamic acid injection administration on the fetus should always be considered along with the mother's clinical need for tranexamic acid injection; an accurate risk-benefit evaluation should drive the treating physician's decision. Data Human Data Tranexamic acid passes through the placenta. The concentration in cord blood after an intravenous injection of 10 mg/kg to pregnant women is about 30 mg/L, as high as in the maternal blood. There were 13 clinical studies that described fetal and/or neonatal functional issues such as low Apgar score, neonatal sepsis, cephalohematoma and 9 clinical studies that discussed alterations to growth including low birth weight and preterm birth at 22 to 36 weeks of gestation in fetuses and infants exposed to tranexamic acid in-utero. Animal Data In embryo-fetal development studies, tranexamic acid was administered to pregnant mice from Gestation day (GD) 6 through GD 12 and rats from GD 9 through GD 14 at daily doses of 0.3 or 1.5 g/kg. There was no evidence of adverse developmental outcomes in mice and rats at multiple of 3 and 6 times the maximum recommended human dose based on body surface area in the mouse and rat, respectively. In rabbits, tranexamic acid was administered intravenously at doses of 50, 100, or 200 mg/kg/day or orally at doses of 100, 200, or 400 mg/kg/day from GD 6 through GD 18. There was no evidence of adverse developmental outcomes at dose multiples of 2 or 3 times, respectively, the maximum recommended human dose based on body surface area. Intravenous doses of 200 mg/kg/day showed slightly retarded weight gain in pregnant rabbits."],"overdosage":["10 OVERDOSAGE Cases of overdosage of tranexamic acid injection have been reported. Based on these reports, symptoms of overdosage may be gastrointestinal, e.g., nausea, vomiting, diarrhea; hypotensive, e.g., orthostatic symptoms; thromboembolic, e.g., arterial, venous, embolic; neurologic, e.g., visual impairment, convulsions, headache, mental status changes; myoclonus; and rash."],"description":["11 DESCRIPTION Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white crystalline powder. The structural formula is Empirical Formula: C 8 H 15 NO 2 Molecular Weight: 157.2 Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid, USP and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0. Structural Formula"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Tranexamic Acid Injection, USP is supplied as follows: Tranexamic Acid Injection, USP NDC (100 mg per mL) Package Factor 83634-401-10 1,000 mg per 10 mL Single-Dose Vial 10 vials per carton Storage Conditions Store at 20º to 25°C (68º to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex."],"geriatric_use":["8.5 Geriatric Use Clinical studies of tranexamic acid injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )] ."],"pediatric_use":["8.4 Pediatric Use There are limited data concerning the use of tranexamic acid injection in pediatric patients with hemophilia who are undergoing tooth extraction. The limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients."],"effective_time":"20240315","pharmacodynamics":["12.2 Pharmacodynamics Tranexamic acid, in concentrations of 1 mg/mL and 10 mg/mL prolongs the thrombin time. An antifibrinolytic concentration of tranexamic acid remains in different tissues for about 17 hours, and in the serum, up to 7 or 8 hours. Tranexamic acid in concentrations up to 10 mg/mL blood has no influence on the platelet count, the coagulation time or various coagulation factors in whole blood or citrated blood from healthy subjects."],"pharmacokinetics":["12.3 Pharmacokinetics Distribution The initial volume of distribution is about 9 to 12 liters. The plasma protein binding of tranexamic acid is about 3% at therapeutic plasma levels and seems to be fully accounted for by its binding to plasminogen. Tranexamic acid does not bind to serum albumin. Elimination After an intravenous dose of 1 g, the plasma concentration time curve shows a triexponential decay with a half-life of about 2 hours for the terminal elimination phase. Excretion Urinary excretion is the main route of elimination via glomerular filtration. Overall renal clearance is equal to overall plasma clearance (110 to 116 mL/min), and more than 95% of the dose is excreted in the urine as unchanged drug. Excretion of tranexamic acid is about 90% at 24 hours after intravenous administration of 10 mg/kg body weight. Specific Populations Patients with Renal Impairment The blood levels of tranexamic acid are increased in patients with renal insufficiency. Urinary excretion following a single intravenous injection of tranexamic acid declines as renal function decreases. Following a single 10 mg/kg intravenous injection of tranexamic acid, the 24-hour urinary fractions of tranexamic acid with serum creatinine concentrations 1.4 to 2.8, 2.8 to 5.7, and greater than 5.7 mg/dL were 51, 39, and 19%, respectively. The 24-hour tranexamic acid plasma concentrations for these patients demonstrated a direct relationship to the degree of renal impairment. Therefore, dose adjustment is needed in patients with renal impairment [see Dosage and Administration ( 2.2 ), Use in Specific Populations ( 8.6 )] . Drug Interaction Studies No studies of interactions between tranexamic acid and other drugs have been conducted."],"adverse_reactions":["6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Thromboembolic Risk [see Warnings and Precautions ( 5.1 )] Seizures [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Visual Disturbances [see Warnings and Precautions ( 5.5 )] Dizziness [see Warnings and Precautions ( 5.6 )] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avenacy Inc. at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of tranexamic acid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction. Allergic dermatitis and giddiness have been reported. Hypotension has been reported when intravenous injection is too rapid. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery, vein obstruction and cases associated with concomitant use of combination hormonal contraceptives) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia. Convulsion, cromatopsia, and visual impairment have also been reported. Anaphylaxis or anaphylactoid reactions have been reported that are suggestive of a causal relationship."],"contraindications":["4 CONTRAINDICATIONS Tranexamic acid injection, USP is contraindicated: In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. In patients with active intravascular clotting [see Warnings and Precautions ( 5.1 )] . In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions ( 5.4 )] . In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction. ( 4 ) In patients with active intravascular clotting. ( 4 ) In patients with severe hypersensitivity reactions to tranexamic acid or any of the ingredients. ( 4 )"],"description_table":["
Empirical Formula: C8H15NO2 Molecular Weight: 157.2
"],"drug_interactions":["7 DRUG INTERACTIONS Prothrombotic Medical Products: Avoid concomitant use, can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid. ( 5.1 , 7.1 , 8.3 ) 7.1 Prothrombotic Medical Products Avoid concomitant use of tranexamic acid injection with medical products that are prothrombotic because concomitant use can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.3 )] ."],"how_supplied_table":["
Tranexamic Acid Injection, USP
NDC(100 mg per mL)Package Factor
83634-401-10 1,000 mg per 10 mL Single-Dose Vial 10 vials per carton
"],"mechanism_of_action":["12.1 Mechanism of Action Tranexamic acid is a synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin by plasmin. In the presence of tranexamic acid, the lysine receptor binding sites of plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing fibrin's matrix structure. The antifibrinolytic effects of tranexamic acid are mediated by reversible interactions at multiple binding sites within plasminogen. Native human plasminogen contains 4 to 5 lysine binding sites with low affinity for tranexamic acid (Kd = 750 μmol/L) and 1 with high affinity (Kd = 1.1 μmol/L). The high affinity lysine site of plasminogen is involved in its binding to fibrin. Saturation of the high affinity binding site with tranexamic acid displaces plasminogen from the surface of fibrin. Although plasmin may be formed by conformational changes in plasminogen, binding to and dissolution of the fibrin matrix is inhibited."],"storage_and_handling":["Storage Conditions Store at 20º to 25°C (68º to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tranexamic acid is a synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin by plasmin. In the presence of tranexamic acid, the lysine receptor binding sites of plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing fibrin's matrix structure. The antifibrinolytic effects of tranexamic acid are mediated by reversible interactions at multiple binding sites within plasminogen. Native human plasminogen contains 4 to 5 lysine binding sites with low affinity for tranexamic acid (Kd = 750 μmol/L) and 1 with high affinity (Kd = 1.1 μmol/L). The high affinity lysine site of plasminogen is involved in its binding to fibrin. Saturation of the high affinity binding site with tranexamic acid displaces plasminogen from the surface of fibrin. Although plasmin may be formed by conformational changes in plasminogen, binding to and dissolution of the fibrin matrix is inhibited. 12.2 Pharmacodynamics Tranexamic acid, in concentrations of 1 mg/mL and 10 mg/mL prolongs the thrombin time. An antifibrinolytic concentration of tranexamic acid remains in different tissues for about 17 hours, and in the serum, up to 7 or 8 hours. Tranexamic acid in concentrations up to 10 mg/mL blood has no influence on the platelet count, the coagulation time or various coagulation factors in whole blood or citrated blood from healthy subjects. 12.3 Pharmacokinetics Distribution The initial volume of distribution is about 9 to 12 liters. The plasma protein binding of tranexamic acid is about 3% at therapeutic plasma levels and seems to be fully accounted for by its binding to plasminogen. Tranexamic acid does not bind to serum albumin. Elimination After an intravenous dose of 1 g, the plasma concentration time curve shows a triexponential decay with a half-life of about 2 hours for the terminal elimination phase. Excretion Urinary excretion is the main route of elimination via glomerular filtration. Overall renal clearance is equal to overall plasma clearance (110 to 116 mL/min), and more than 95% of the dose is excreted in the urine as unchanged drug. Excretion of tranexamic acid is about 90% at 24 hours after intravenous administration of 10 mg/kg body weight. Specific Populations Patients with Renal Impairment The blood levels of tranexamic acid are increased in patients with renal insufficiency. Urinary excretion following a single intravenous injection of tranexamic acid declines as renal function decreases. Following a single 10 mg/kg intravenous injection of tranexamic acid, the 24-hour urinary fractions of tranexamic acid with serum creatinine concentrations 1.4 to 2.8, 2.8 to 5.7, and greater than 5.7 mg/dL were 51, 39, and 19%, respectively. The 24-hour tranexamic acid plasma concentrations for these patients demonstrated a direct relationship to the degree of renal impairment. Therefore, dose adjustment is needed in patients with renal impairment [see Dosage and Administration ( 2.2 ), Use in Specific Populations ( 8.6 )] . Drug Interaction Studies No studies of interactions between tranexamic acid and other drugs have been conducted."],"indications_and_usage":["1 INDICATIONS AND USAGE Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use. ( 5.1 ) Risk of Medication Errors Due to Incorrect Route of Administration: FOR INTRAVENOUS USE ONLY. ( 5.2 ) Seizures: Inadvertent injection into neuraxial system may result in seizures. ( 5.3 ) Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention. ( 5.4 ) Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur. ( 5.5 ) Dizziness: Advise patients not to drive if dizziness occurs. ( 5.6 ) 5.1 Thromboembolic Risk Tranexamic acid injection is contraindicated in patients with active intravascular clotting. Tranexamic acid is an antifibrinolytic and may increase the risk of thromboembolic events. Venous and arterial thrombosis or thromboembolism has been reported in patients treated with tranexamic acid injection. Avoid concomitant use of tranexamic acid injection and medical products that are pro-thrombotic, as the risk of thrombosis may be increased. These medications include but are not limited to, Factor IX Complex concentrates, Anti-inhibitor Coagulant concentrates, and hormonal contraceptives [see Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.3 )] . 5.2 Risk of Medication Errors Due to Incorrect Route of Administration Tranexamic acid injection is for intravenous use only. Serious adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered intrathecally instead of intravenously. Confirm the correct route of administration for tranexamic acid injection and avoid confusion with other injectable solutions that might be administered at the same time as tranexamic acid injection. Syringes containing tranexamic acid injection should be clearly labeled with the intravenous route of administration. 5.3 Seizures Tranexamic acid injection may cause seizures, including focal and generalized seizures. The most common setting for tranexamic acid-induced seizures has been during cardiovascular surgery (a setting in which tranexamic acid is not FDA-approved and which uses doses of up to 10-fold higher than the recommended human dose and in patients inadvertently given tranexamic acid into the neuraxial system). Tranexamic acid injection is not approved and not recommended for neuraxial administration. Consider dose reduction during surgery and dose adjustments for patients with clinical conditions such as renal dysfunction. Closely monitor the patient during surgery. Consider electroencephalogram (EEG) monitoring for patients with history of seizures or who experience myoclonic movements, twitching, or show evidence of focal seizures. Discontinue tranexamic acid injection if seizures occur. 5.4 Hypersensitivity Reactions Cases of hypersensitivity reactions, including anaphylactic reactions, have occurred with use of intravenous tranexamic acid. Discontinue treatment with tranexamic acid injection if serious reaction occurs, provide appropriate medical management, and do not restart treatment. Tranexamic acid injection is contraindicated in patients with a history of hypersensitivity to tranexamic acid. 5.5 Visual Disturbances Although not seen in humans, focal areas of retinal degeneration have been observed in cats and dogs following oral or intravenous tranexamic acid at doses between 250 to 1,600 mg/kg/day (1.6 to 22 times the recommended usual human dose based on body surface area) from 6 days to 1 year. No retinal changes have been observed in eye examinations of patients treated with tranexamic acid for up to 8 years. Patients expected to be treated for greater than 3 months may consider ophthalmic monitoring including visual acuity and optical coherence tomography at regular intervals. Discontinue tranexamic acid injection if changes in ophthalmological examination occurs. 5.6 Dizziness Tranexamic acid injection may cause dizziness. Concomitant use of other drugs that may also cause dizziness may worsen this effect. Advise patients to avoid driving or using machines until they know how tranexamic acid injection affects them."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Tranexamic acid was not carcinogenic in a 2-year study in rats and mice at oral doses up to 3 and 5.3 g/kg/day, which are approximately 12 and 11 times the maximum recommended human dose based on body surface area, respectively. Tranexamic acid was not genotoxic in the reverse mutation bacterial (Ames) test, and in vitro and in vivo cytogenetic test. In a fertility and early embryonic development study, tranexamic acid was administered to male rats as 0.3% and 1% of drug in diet (average doses of 222 and 856 mg/kg/day) or to female rats at dose levels of 0.3% and 1.2% of drug in diet. Tranexamic acid had no effect on fertility or reproductive function of male or female rats at dose multiples of 4 or 5 times the maximum recommended human dose based on body surface area, respectively. 13.2 Animal Toxicology and/or Pharmacology Nonclinical studies have shown a retinal toxicity associated with tranexamic acid. Toxicity is characterized by retinal atrophy commencing with changes to the retinal pigmented epithelium and progressing to retinal detachment in cats. The toxicity appears to be dose related, and changes are partially reversible at lower doses. Effects were observed in dogs at oral doses of 800 mg/kg/day and higher (multiple of 11 times the maximum human dose based on body surface area), and in cats at 250 mg/kg/day for 14 days (multiple of 1.6 times the maximum human dose based on body surface area). Some fully reversible changes in pigmentation were observed in cats at doses of 125 mg/kg/day (multiple of 0.8 times the maximum human dose based on body surface area). Studies suggest that the underlying mechanism may be related to a transient retinal ischemia at high exposures, linked to the known sympathomimetic effect of high plasma exposures of tranexamic acid."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Thromboembolic Risk Inform patients that tranexamic acid injection may increase the risk of venous and arterial thrombosis or thromboembolism and to contact their healthcare provider for any signs or symptoms suggestive of thromboembolism. Advise patients using hormonal contraception that combined use with tranexamic acid injection may increase the risk for thromboembolic adverse reactions and to use effective alternative (nonhormonal) contraception during therapy with tranexamic acid injection [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.3 )] . Seizures Inform patients that tranexamic acid injection may cause seizures and to contact their healthcare provider for any signs or symptoms suggestive of seizures [see Warnings and Precautions ( 5.3 )] . Hypersensitivity Reactions Inform patients that tranexamic acid injection may cause hypersensitivity reactions and to contact their healthcare provider for any signs or symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.4 )] . Visual Disturbances Inform patients that tranexamic acid injection can cause visual disturbance and that they should report any eye symptoms or change in their vision to their healthcare provider and to follow-up with an ophthalmologist for a complete ophthalmologic evaluation, including dilated retinal examination of the retina [see Warnings and Precautions ( 5.5 )] . Risk of Driving and Operating Machinery Inform patients that tranexamic acid injection may cause dizziness, and that the patient should be cautioned about driving, operating machinery, or performing hazardous tasks while taking tranexamic acid injection [see Warnings and Precautions ( 5.6 )] . AVENACY Mfd. for Avenacy Schaumburg, IL 60173 (USA) Made in India ©2024 Avenacy Inc. Revised: February 2024"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy. ( 2.1 ) After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days. Infuse no more than 1 mL/minute to avoid hypotension. ( 2.1 ) Reduce the dosage for patients with renal impairment. ( 2.2 , 8.6 ) 2.1 Recommended Dosage The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight intravenously administered as a single-dose, immediately before tooth extractions. Infuse no more than 1 mL/minute to avoid hypotension [see Warnings and Precautions ( 5.1 )]. Following tooth extraction, tranexamic acid injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. Heparin may be added to tranexamic acid injection. Tranexamic acid injection should NOT be mixed with blood. The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin. Discard any unused portion. The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration. 2.2 Recommended Dosage for Patients With Varying Degrees of Renal Impairment * For patients with moderate to severe impaired renal function, the following dosages are recommended: Table 1: Recommended Dosage in Patients With Varying Degrees of Renal Impairment * Dose reduction is recommended for all doses, both before and after tooth extraction. Serum Creatinine (mg/dL) Tranexamic Acid Intravenous Dosage 1.36 to 2.83 (120 to 250 micromol/L) 10 mg/kg twice daily 2.83 to 5.66 (250 to 500 micromol/L) 10 mg/kg daily >5.66 (>500 micromol/L) 10 mg/kg every 48 hours or 5 mg/kg every 24 hours"],"spl_product_data_elements":["tranexamic acid tranexamic acid tranexamic acid tranexamic acid water"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Injection: 1,000 mg tranexamic acid (100 mg per mL) clear and colorless solution in 10 mL single-dose vials. Injection: 1,000 mg tranexamic acid (100 mg per mL) in 10 mL single-dose vials. ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see Data ) . Reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. Doses examined were multiples of up to 3 times (mouse), 6 times (rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively (see Data ) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. It is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. For decisions regarding the use of tranexamic acid injection during pregnancy, the potential risk of tranexamic acid injection administration on the fetus should always be considered along with the mother's clinical need for tranexamic acid injection; an accurate risk-benefit evaluation should drive the treating physician's decision. Data Human Data Tranexamic acid passes through the placenta. The concentration in cord blood after an intravenous injection of 10 mg/kg to pregnant women is about 30 mg/L, as high as in the maternal blood. There were 13 clinical studies that described fetal and/or neonatal functional issues such as low Apgar score, neonatal sepsis, cephalohematoma and 9 clinical studies that discussed alterations to growth including low birth weight and preterm birth at 22 to 36 weeks of gestation in fetuses and infants exposed to tranexamic acid in-utero. Animal Data In embryo-fetal development studies, tranexamic acid was administered to pregnant mice from Gestation day (GD) 6 through GD 12 and rats from GD 9 through GD 14 at daily doses of 0.3 or 1.5 g/kg. There was no evidence of adverse developmental outcomes in mice and rats at multiple of 3 and 6 times the maximum recommended human dose based on body surface area in the mouse and rat, respectively. In rabbits, tranexamic acid was administered intravenously at doses of 50, 100, or 200 mg/kg/day or orally at doses of 100, 200, or 400 mg/kg/day from GD 6 through GD 18. There was no evidence of adverse developmental outcomes at dose multiples of 2 or 3 times, respectively, the maximum recommended human dose based on body surface area. Intravenous doses of 200 mg/kg/day showed slightly retarded weight gain in pregnant rabbits. 8.2 Lactation Risk Summary Published literature reports the presence of tranexamic acid in human milk. There are no data on the effects of tranexamic acid on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tranexamic acid injection and any potential adverse effects on the breastfed child from tranexamic acid injection or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Contraception Concomitant use of tranexamic acid injection, which is an antifibrinolytic, with hormonal contraceptives may increase the risk for thromboembolic adverse reactions. Advise patients to use an effective alternative (nonhormonal) contraceptive method [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )] . 8.4 Pediatric Use There are limited data concerning the use of tranexamic acid injection in pediatric patients with hemophilia who are undergoing tooth extraction. The limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients. 8.5 Geriatric Use Clinical studies of tranexamic acid injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )] . 8.6 Renal Impairment Reduce the dosage of tranexamic acid injection in patients with renal impairment, based on the patient's serum creatinine [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )] ."],"dosage_and_administration_table":["
Table 1: Recommended Dosage in Patients With Varying Degrees of Renal Impairment
* Dose reduction is recommended for all doses, both before and after tooth extraction.
Serum Creatinine (mg/dL)Tranexamic Acid Intravenous Dosage
1.36 to 2.83 (120 to 250 micromol/L) 10 mg/kg twice daily
2.83 to 5.66 (250 to 500 micromol/L) 10 mg/kg daily
>5.66 (>500 micromol/L) 10 mg/kg every 48 hours or 5 mg/kg every 24 hours
"],"animal_pharmacology_and_or_toxicology":["13.2 Animal Toxicology and/or Pharmacology Nonclinical studies have shown a retinal toxicity associated with tranexamic acid. Toxicity is characterized by retinal atrophy commencing with changes to the retinal pigmented epithelium and progressing to retinal detachment in cats. The toxicity appears to be dose related, and changes are partially reversible at lower doses. Effects were observed in dogs at oral doses of 800 mg/kg/day and higher (multiple of 11 times the maximum human dose based on body surface area), and in cats at 250 mg/kg/day for 14 days (multiple of 1.6 times the maximum human dose based on body surface area). Some fully reversible changes in pigmentation were observed in cats at doses of 125 mg/kg/day (multiple of 0.8 times the maximum human dose based on body surface area). Studies suggest that the underlying mechanism may be related to a transient retinal ischemia at high exposures, linked to the known sympathomimetic effect of high plasma exposures of tranexamic acid."],"package_label_principal_display_panel":["PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – Vial Label NDC 83634-401-41 Tranexamic Acid Injection, USP 1,000 mg per 10 mL (100 mg per mL) Intravenous Use Only 10 mL Single-Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – Vial Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Tranexamic acid was not carcinogenic in a 2-year study in rats and mice at oral doses up to 3 and 5.3 g/kg/day, which are approximately 12 and 11 times the maximum recommended human dose based on body surface area, respectively. Tranexamic acid was not genotoxic in the reverse mutation bacterial (Ames) test, and in vitro and in vivo cytogenetic test. In a fertility and early embryonic development study, tranexamic acid was administered to male rats as 0.3% and 1% of drug in diet (average doses of 222 and 856 mg/kg/day) or to female rats at dose levels of 0.3% and 1.2% of drug in diet. Tranexamic acid had no effect on fertility or reproductive function of male or female rats at dose multiples of 4 or 5 times the maximum recommended human dose based on body surface area, respectively."]},"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"600 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"595 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"346 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"324 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"301 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"297 reports"},{"date":"","signal":"HYPOTENSION","source":"FDA FAERS","actionTaken":"294 reports"},{"date":"","signal":"HAEMORRHAGE","source":"FDA FAERS","actionTaken":"279 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"269 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"266 reports"}],"drugInteractions":[{"drug":"Prothrombotic medical products","severity":"Significant","mechanism":"Additive prothrombotic effects","management":"Avoid concomitant use","clinicalEffect":"Further increased risk of thromboembolic adverse reactions"}],"commonSideEffects":[{"effect":"Nausea","drugRate":"6.1%","placeboRate":"","totalAtRisk":6140,"totalAffected":372,"trialsReporting":2},{"effect":"Vomiting","drugRate":"4.8%","placeboRate":"","totalAtRisk":6140,"totalAffected":295,"trialsReporting":2},{"effect":"Dizziness","drugRate":"2.8%","placeboRate":"","totalAtRisk":6140,"totalAffected":169,"trialsReporting":2},{"effect":"Urticaria or dermatitis","drugRate":"1.1%","placeboRate":"","totalAtRisk":5529,"totalAffected":63,"trialsReporting":1}],"contraindications":["Subarachnoid hemorrhage (risk of cerebral edema and cerebral infarction)","Active intravascular clotting","Hypersensitivity to tranexamic acid or any ingredients"],"specialPopulations":{"Lactation":"Published literature reports the presence of tranexamic acid in human milk. There are no data on the effects of tranexamic acid on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CYKLOKAPRON and any potential adverse effects on the breastfed child.","Pregnancy":"Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration. Reproduction studies in mice, rats, and rabbits have not revealed any adverse effects on the fetus. For decisions regarding use during pregnancy, the potential risk on the fetus should always be considered along with the mother's clinical need; an accurate risk-benefit evaluation should drive the treating physician's decision.","Geriatric Use":"Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. This drug is substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.","Pediatric Use":"There are limited data concerning the use of CYKLOKAPRON in pediatric patients with hemophilia who are undergoing tooth extraction. The limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients.","Renal Impairment":"Reduce the dosage of CYKLOKAPRON in patients with renal impairment, based on the patient's serum creatinine.","Females and Males of Reproductive Potential":"Concomitant use of CYKLOKAPRON with hormonal contraceptives may increase the risk for thromboembolic adverse reactions. Advise patients to use an effective alternative (nonhormonal) contraceptive method."}},"trials":[],"_chembl":null,"_pubmed":{"count":8453,"papers":[{"date":"2026 Mar 23","pmid":"41893574","title":"Therapeutic Effects of Single and Combined Anti-Disseminated Intravascular Coagulation (DIC) Drugs in a Rat Venom-Induced Consumption Coagulopathy (VICC) Model Using Yamakagashi (Rhabdophis tigrinus) Venom.","authors":"Yamamoto A","journal":"Toxins"},{"date":"2026 Mar 26","pmid":"41887609","title":"Efficacy of Intra-Articular Tranexamic Acid in Reducing Early Postoperative Swelling and Pain Following Arthroscopic ACL Reconstruction: A Randomized Comparative Study.","authors":"Harna B","journal":"The journal of knee surgery"},{"date":"2026 Mar 27","pmid":"41885773","title":"Investigating the Influence of Tranexamic Acid on Adipocyte Differentiation in an In Vitro Model.","authors":"Ellis G","journal":"Annals of plastic surgery"},{"date":"2026 Mar-Apr","pmid":"41884735","title":"Efficacy of Tranexamic acid Microneedling versus Intradermal Injection of Tranexamic Acid in the Treatment of Melasma - A Randomised Controlled Trial.","authors":"Srijha M","journal":"Indian journal of dermatology"},{"date":"2026 Mar 9","pmid":"41883777","title":"Critical care in hematopoietic stem cell transplantation: Common complications and management.","authors":"Gupta N","journal":"World journal of critical care medicine"}]},"_rxnorm":{"forms":[{"tty":"SBD","name":"10 ML tranexamic acid 100 MG/ML Injection [Cyklokapron]","rxcui":"208104"},{"tty":"SBD","name":"tranexamic acid 650 MG Oral Tablet [Lysteda]","rxcui":"883830"},{"tty":"SCD","name":"tranexamic acid 500 MG Oral Tablet","rxcui":"104481"},{"tty":"SCD","name":"100 ML tranexamic acid 10 MG/ML Injection","rxcui":"2170286"},{"tty":"SCD","name":"10 ML tranexamic acid 100 MG/ML Injection","rxcui":"238720"},{"tty":"SCD","name":"azelaic acid 50 MG/ML / tranexamic acid 10 MG/ML Topical Cream","rxcui":"2672350"},{"tty":"SCD","name":"tranexamic acid 650 MG Oral Tablet","rxcui":"883826"}]},"aliases":[],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$1.4343/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$524","description":"TRANEXAMIC ACID 650 MG TABLET","retrievedDate":"2026-04-07"}],"_fixedAt":"2026-03-30T11:24:52.114673","_recalls":[{"date":"20150429","reason":"Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.","status":"Terminated","classification":"Class II"},{"date":"20140122","reason":"Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.","status":"Terminated","classification":"Class II"},{"date":"20221012","reason":"Presence of Particulate Matter: Piece of metal found in a vial","status":"Ongoing","classification":"Class III"},{"date":"20140122","reason":"Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.","status":"Terminated","classification":"Class II"},{"date":"20230621","reason":"Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.","status":"Terminated","classification":"Class III"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Tranexamic Acid","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:28:02.094832+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Tranexamic Acid","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:28:09.819502+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"Haiku strategic summary","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:55:37.489555+00:00"},"mechanism":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:28:13.202820+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:28:07.845495+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:28:02.166304+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:28:01.212406+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:28:13.202843+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Tranexamic Acid","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:28:08.194822+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:27:59.320135+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:27:59.320166+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:27:59.320172+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:28:10.283184+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku extraction","aiModel":"claude-haiku-4-5","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:37.489526+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Plasminogen inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:28:09.819383+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:37.489553+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL877/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:28:09.478594+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:37.489549+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA203521","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:27:59.320174+00:00"}},"offLabel":[],"timeline":[{"date":"19861230","type":"positive","milestone":"FDA approval — PFIZER","regulator":"FDA","description":""}],"_dailymed":{"setId":"6e89a7d9-4da4-42aa-b7f8-c602c24eefe5","title":"CYKLOKAPRON (TRANEXAMIC ACID) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]","labeler":"","products":[],"publishedDate":"Sep 08, 2025"},"aiSummary":"Tranexamic acid is an antifibrinolytic agent indicated for short-term use (2-8 days) in hemophilia patients undergoing tooth extraction to reduce hemorrhage and replacement therapy needs. The drug works by occupying plasmin's lysine binding sites on fibrin, preventing fibrin dissolution and stabilizing clot structure. Key risks include contraindication in subarachnoid hemorrhage due to cerebral complications and increased thromboembolic risk with concomitant prothrombotic agents. Dose adjustment is required in renal impairment as the drug is primarily eliminated unchanged in urine.","ecosystem":[],"mechanism":{"target":"Plasminogen lysine binding sites; fibrin","novelty":"me-too","modality":"Synthetic lysine amino acid derivative","drugClass":"Antifibrinolytic agent","explanation":"Tranexamic acid is a synthetic lysine amino acid derivative that diminishes the dissolution of hemostatic fibrin by plasmin. The drug works by occupying the lysine receptor binding sites of plasmin for fibrin, preventing plasmin from binding to fibrin monomers and thus preserving and stabilizing fibrin's matrix structure.\n\nThe antifibrinolytic effects are mediated through reversible interactions at multiple binding sites within plasminogen. Native human plasminogen contains 4 to 5 lysine binding sites with low affinity for tranexamic acid (Kd = 750 μmol/L) and 1 with high affinity (Kd = 1.1 μmol/L). The high affinity lysine site is involved in plasminogen's binding to fibrin.\n\nSaturation of the high affinity binding site with tranexamic acid displaces plasminogen from the fibrin surface. Although plasmin may still be formed through conformational changes in plasminogen, binding to and dissolution of the fibrin matrix is inhibited.","oneSentence":"Tranexamic acid occupies lysine receptor binding sites on plasmin, preventing fibrin dissolution.","technicalDetail":"Tranexamic acid achieves reversible, competitive inhibition of plasminogen through saturation of its high-affinity lysine binding site (Kd = 1.1 μmol/L), displacing plasminogen from fibrin surfaces. The drug exhibits lower-affinity interactions at 4-5 additional lysine binding sites (Kd = 750 μmol/L) on plasminogen. This multi-site binding mechanism prevents both plasminogen recruitment to fibrin and subsequent plasmin-mediated fibrinolysis, thereby stabilizing hemostatic clots and reducing hemorrhage in hemophilic patients."},"_scrapedAt":"2026-03-27T23:27:57.688Z","_scrapedBy":"cloudflare-swarm","_whoStatus":[{"name":"Tranexamic Acid","type":"Essential Medicines List","status":"Listed","rawText":"FILTERS\nEML section\nAny\n1. Anaesthetics, preoperative medicines and medical gases (0)\n1.1. General anaesthetics and oxygen (0)\n1.1.1. General anaesthetics and oxygen > Inhalational medicines (0)\n1.1.2. General anaesthetics and oxygen > Injectable medicines (0)\n1.2. Local anaesthetics (0)\n1.3. Preoperative medication and sedation for short-term procedures (0)\n1.4. Medical gases (0)\n2. Medicines for pain and palliative care (0)\n2.1. Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs","regulator":"WHO"}],"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Tranexamic_acid","title":"Tranexamic acid","extract":"Tranexamic acid is a medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation. It is also used for hereditary angioedema. It is taken either by mouth, injection into a vein, or by intramuscular injection.","infobox":"{{Short description|Chemical compound}}\n{{Redirect|Amcha|the Jewish shibboleth used during World War II|Amcho}}\n{{Use dmy dates|date=March 2024}}\n{{cs1 config |name-list-style=vanc |display-authors=6}}\n{{Infobox drug\n| verifiedrevid = 477001216\n| image = Tranexam.svg\n| image_class = skin-invert-image\n| width = 200\n| alt =\n| image2 = Tranexamic acid ball-and-stick model from xtal 2023.png\n| image_class2 = bg-transparent\n| width2 = 250px\n\n| pronounce = \\ˌtran-eks-ˌam-ik-\\\n| tradename = Cyklokapron, others\n| Drugs.com = {{drugs.com|monograph|tranexamic-acid}}\n| MedlinePlus = a612021\n| DailyMedID = Tranexamic acid\n| pregnancy_AU = B1\n| pregnancy_AU_comment = \n| pregnancy_category = \n| routes_of_administration = [[By mouth]], [[Intravenous therapy|intravenous]], [[Topical administration|topical]]\n| class = \n| ATC_prefix = B02\n| ATC_suffix = AA02\n| ATC_supplemental =\n\n\n| legal_AU = S4\n| legal_AU_comment = {{cite web | title=Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/resources/publication/publications/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2017 | access-date=30 March 2024 | archive-date=6 July 2023 | archive-url=https://web.archive.org/web/20230706023149/https://www.tga.gov.au/resources/publication/publications/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2017 | url-status=live }}{{Cite web | title=TRANEXAMIC ACID WAYMADE (Waymade Australia Pty Limited) {{!}} Therapeutic Goods Administration (TGA) | url=https://www.tga.gov.au/resources/prescription-medicines-registrations/tranexamic-acid-waymade-waymade-australia-pty-limited | archive-url=https://web.archive.org/web/20250416195331/https://www.tga.gov.au/resources/prescription-medicines-registrations/tranexamic-acid-waymade-waymade-australia-pty-limited | access-date=2025-08-29 | archive-date=2025-04-16}}\n| legal_BR = \n| legal_BR_comment = \n| legal_CA = \n| legal_CA_comment = \n| legal_DE = \n| legal_DE_comment = \n| legal_NZ = \n| legal_NZ_comment = \n| legal_UK = POM\n| legal_UK_comment = / P{{cite web | title=Evana Heavy Period Relief Summary of Product Characteristics (SmPC) | website=(emc) | date=24 April 2024 | url=https://www.medicines.org.uk/emc/product/15636/smpc | access-date=14 May 2024}}\n| legal_US = Rx-only\n| legal_US_comment = \n| legal_EU = \n| legal_EU_comment = \n| legal_UN = \n| legal_UN_comment = \n| legal_status = Rx generally; OTC (including oral) in Japan{{cite conference |url=https://www.mhlw.go.jp/co","description":"Chemical compound","wiki_medical_uses":"===Medical uses===\n[[File:TXAVial2017.jpg|thumb|A one-gram ampoule of tranexamic acid]]\nTranexamic acid is frequently used following major trauma.{{cite journal | vauthors = Binz S, McCollester J, Thomas S, Miller J, Pohlman T, Waxman D, Shariff F, Tracy R, Walsh M | title = CRASH-2 Study of Tranexamic Acid to Treat Bleeding in Trauma Patients: A Controversy Fueled by Science and Social Media | journal = Journal of Blood Transfusion | volume = 2015 | article-number = 874920|year=2015 | pmid = 26448897 | pmc = 4576020 | doi = 10.1155/2015/874920 | doi-access = free | title-link = doi }} Tranexamic acid is used to prevent and treat blood loss in a variety of situations, such as dental procedures, heavy menstrual bleeding, and surgeries with high risk of blood loss.{{cite journal | vauthors = Melvin JS, Stryker LS, Sierra RJ | title = Tranexamic Acid in Hip and Knee Arthroplasty | journal = The Journal of the American Academy of Orthopaedic Surgeons | volume = 23 | issue = 12 | pages = 732–40|year=2015 | pmid = 26493971 | doi = 10.5435/JAAOS-D-14-00223 | s2cid = 41823501 }}{{cite journal | vauthors = Tengborn L, Blombäck M, Berntorp E | title = Tranexamic acid--an old drug still going strong and making a revival | journal = Thrombosis Research | volume = 135 | issue = 2 | pages = 231–42|year=2015 | pmid = 25559460 | doi = 10.1016/j.thromres.2014.11.012 }}\n\n====Trauma====\nTranexamic acid has been found to decrease the risk of death due to any cause in people who have significant bleeding due to [[major trauma|trauma]].{{cite journal | vauthors = Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, Cook L, Kawahara T, Perel P, Prieto-Merino D, Ramos M, Cairns J, Guerriero C | title = The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients | journal = ","wiki_society_and_culture":"==Society and culture==\nTranexamic acid was first synthesized in 1962 by Japanese researchers Shosuke and [[Utako Okamoto]]. It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].\n\n===Brand names===\nTranexamic acid is marketed in the US and Australia in tablet form as Lysteda and in Australia, Sweden{{cite web |title=Substans - Tranexamsyra |url=https://www.fass.se/LIF/substance?userType=0&substanceId=IDE4POCLU9M3PVERT1 |website=FASS |publisher=FASS.se |access-date=19 April 2021 |archive-date=19 April 2021 |archive-url=https://web.archive.org/web/20210419183540/https://www.fass.se/LIF/substance?userType=0&substanceId=IDE4POCLU9M3PVERT1 |url-status=live }} and Jordan it is marketed in an [[intravenous therapy|IV]] form and tablet form as Cyklokapron, in the UK and Sweden as Cyclo-F. In the UK it is also marketed as Femstrual, in Asia as Transcam, in Bangladesh as Intrax & Tracid, in India as Pause, in Pakistan as Transamin, in Indonesia as Kalnex, in South America as Espercil, in Japan as Nicolda, in France, Poland, Belgium, and Romania as Exacyl and in Egypt as Kapron. In the Philippines, its capsule form is marketed as Hemostan and in Israel as Hexakapron.{{citation needed|date=June 2016}}\n\n=== Legal status ===\nThe US Food and Drug Administration (FDA) approved tranexamic acid oral tablets (brand name Lysteda) for the treatment of heavy menstrual bleeding in November 2009.{{cite web | title=Drug Approval Package: Lysteda (tranexamic acid) NDA #022430 | website=U.S. [[Food and Drug Administration]] (FDA) | date=6 May 2010 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430_lysteda_toc.cfm | access-date=14 May 2024 | archive-date=16 April 2024 | archive-url=https://web.archive.org/web/20240416051658/https:"},"commercial":{"launchDate":"1986","annualCostUS":"$50-200/month","currentRevenue":"Generic — no single company revenue","peakSalesEstimate":"$150M"},"references":[],"_validation":{"fieldsValidated":6,"lastValidatedAt":"2026-04-20T08:28:16.815470+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"name":"Amicar (Aminocaproic Acid)","company":"Xanodyne Pharmaceuticals","advantage":"Older antifibrinolytic agent; oral and IV formulations available; longer half-life allows less frequent dosing"},{"name":"Lysteda (Tranexamic Acid)","company":"Pfizer","advantage":"Oral formulation of tranexamic acid; convenient for heavy menstrual bleeding; avoids IV administration"},{"name":"Hemabate (Carboprost)","company":"Pfizer","advantage":"Uterotonic agent; alternative for postpartum hemorrhage; works through different mechanism (uterine contraction)"},{"name":"Miacalcin (Calcitonin)","company":"Novartis","advantage":"Alternative for bleeding disorders; reduces bone resorption and platelet dysfunction; useful in uremic bleeding"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Reduce or prevent hemorrhage in hemophilia patients during tooth extraction","regulator":"FDA"},{"name":"Reduce or prevent hemorrhage in hemophilia patients following tooth extraction","regulator":"FDA"},{"name":"Reduce need for replacement therapy in hemophilia patients during tooth extraction","regulator":"FDA"},{"name":"Reduce need for replacement therapy in hemophilia patients following tooth extraction","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_drugWebsite":{"url":"https://www.cyklokapron.com","source":"Drug branded website","content":"Sorry, you have been blocked\nYou are unable to access cyklokapron.com\nWhy have I been blocked?\n\nThis website is using a security service to protect itself from online attacks. The action you just performed triggered the security solution. There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data.\n\nWhat can I do to resolve this?\n\nYou can email the site owner to let them know you were blocked. Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page.\n\nCloudflare Ray ID: 9e3411d40d0e82ba • Performance & security by Cloudflare"},"_fixedFields":["generics(26)","patents(0)"],"labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT07495748","phase":"NA","title":"Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma","status":"NOT_YET_RECRUITING","sponsor":"Foundation University Islamabad","startDate":"2026-07-01","conditions":"Melasma","enrollment":70,"completionDate":"2027-07-01","primaryEndpoint":"Mean reduction in MASI (MASI) score"},{"nctId":"NCT03540368","phase":"NA","title":"Tranexamic Acid for The Treatment of Gastrointestinal Bleeding","status":"COMPLETED","sponsor":"Indonesia University","startDate":"2018-07-01","conditions":"Gastrointestinal 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days"},{"nctId":"NCT07263841","phase":"PHASE2","title":"Comparison of Effectiveness of Tranexamic Acid Mesotherapy Versus Glutathione Mesotherapy in Post Burn Facial Hyperpigmentation","status":"ACTIVE_NOT_RECRUITING","sponsor":"King Edward Medical University","startDate":"2025-06-01","conditions":"Post Burn Facial Hyperpigmentation","enrollment":60,"completionDate":"2026-03-26","primaryEndpoint":"improvement in facial hyperpigmentation"},{"nctId":"NCT07261930","phase":"PHASE4","title":"Effectiveness of Tranexamic Acid in Reducing Blood Loss During Femoral Nail Surgery","status":"COMPLETED","sponsor":"Masaka Regional Referral Hospital","startDate":"2018-10-01","conditions":"Femoral Fractures, Hemorrhage, Surgical, Tranexamic Acid Use","enrollment":43,"completionDate":"2019-05-01","primaryEndpoint":"Change in Hemoglobin Concentration from Preoperative to 72 Hours Postoperative"},{"nctId":"NCT07195539","phase":"NA","title":"CO2 Fractional Laser With Tranexamic Acid As An Effective Tool For Post Burn Hyperpigmentation.","status":"ENROLLING_BY_INVITATION","sponsor":"King Edward Medical University","startDate":"2025-06-01","conditions":"Post Burn Hyperpigmentation","enrollment":30,"completionDate":"2026-02-28","primaryEndpoint":"improvement in hyperpigmentation"},{"nctId":"NCT07212452","phase":"PHASE2, PHASE3","title":"Tranexamic Acid : Nebulization vs IV Route for Hemoptysis","status":"COMPLETED","sponsor":"University of Health Sciences Lahore","startDate":"2025-08-01","conditions":"Hemoptysis, NEBULIZATION, Tranexamic Acid","enrollment":172,"completionDate":"2025-10-31","primaryEndpoint":"Time to control hemoptysis"},{"nctId":"NCT03822793","phase":"PHASE2","title":"A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","startDate":"2023-12-07","conditions":"Arthropathy of Hip","enrollment":170,"completionDate":"2025-07-11","primaryEndpoint":"haemoglobin decrease in the perioperative period"},{"nctId":"NCT05441592","phase":"PHASE4","title":"A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery","status":"COMPLETED","sponsor":"University of Michigan","startDate":"2022-08-15","conditions":"Hematoma Postoperative","enrollment":107,"completionDate":"2024-10-22","primaryEndpoint":"Hematomas"},{"nctId":"NCT07202156","phase":"NA","title":"Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma","status":"RECRUITING","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2024-10-20","conditions":"Melasma (Facial Melasma)","enrollment":35,"completionDate":"2026-02-25","primaryEndpoint":"percentage reduction in hemi-MASI"},{"nctId":"NCT05945680","phase":"PHASE4","title":"Tranexamic Acid in Breast Esthetic Surgery.","status":"COMPLETED","sponsor":"Poznan University of Medical Sciences","startDate":"2023-09-15","conditions":"Hemorrhage, Bleeding","enrollment":60,"completionDate":"2025-09-30","primaryEndpoint":"Blood loss volume"},{"nctId":"NCT06086444","phase":"PHASE4","title":"Tranexamic Acid in Abdominoplasty.","status":"COMPLETED","sponsor":"Poznan University of Medical Sciences","startDate":"2023-10-17","conditions":"Abdominal Wall Defect, Hemorrhage, Bleeding","enrollment":60,"completionDate":"2025-10-10","primaryEndpoint":"Blood loss volume"},{"nctId":"NCT05840471","phase":"NA","title":"Tranexamic Acid as an Intervention in Abruptio Placenta","status":"COMPLETED","sponsor":"Hawler Medical University","startDate":"2023-01-10","conditions":"Vaginal Bleeding, Prolonged Pregnancy","enrollment":116,"completionDate":"2024-02-10","primaryEndpoint":"Hemostasis"},{"nctId":"NCT04811313","phase":"NA","title":"Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy","status":"RECRUITING","sponsor":"Assiut University","startDate":"2025-04-03","conditions":"Intraoperative Blood Loss, Pediatric, Orthopedic Disorder","enrollment":400,"completionDate":"2026-03","primaryEndpoint":"amount of intraoperative blood loss"},{"nctId":"NCT04344860","phase":"PHASE3","title":"Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial","status":"COMPLETED","sponsor":"Nicoletta C Machin","startDate":"2021-06-04","conditions":"Von Willebrand Diseases, Postpartum Hemorrhage","enrollment":20,"completionDate":"2024-09-01","primaryEndpoint":"Volume of Quantitative Blood Loss at Delivery"},{"nctId":"NCT03136445","phase":"PHASE3","title":"TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia","status":"COMPLETED","sponsor":"NHS Blood and Transplant","startDate":"2015-06","conditions":"Hematologic Neoplasms, Hemorrhage, Hematopoietic Stem Cell Transplantation","enrollment":616,"completionDate":"2022-06-18","primaryEndpoint":"The Proportion of Patients Who Die or Have Bleeding of WHO Grade 2 or Above by WHO Criteria During the First 30 Days From the First Dose of Trial Treatment, or Planned First Dose for Those Participant"},{"nctId":"NCT07116395","phase":"PHASE4","title":"Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma","status":"NOT_YET_RECRUITING","sponsor":"Arbi Nazarian, MD","startDate":"2026-01-01","conditions":"Patients Undergoing Operative Fixation of Long Bone Fractures Within the Community Medical Centers System","enrollment":200,"completionDate":"2030-12-31","primaryEndpoint":"Estimated blood loss (EBL) comparison between those who received TXA vs no TXA"},{"nctId":"NCT05794321","phase":"PHASE2","title":"Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy","status":"RECRUITING","sponsor":"University of California, San Francisco","startDate":"2023-09-28","conditions":"Postoperative Hematoma, Postoperative Seroma","enrollment":150,"completionDate":"2026-05","primaryEndpoint":"Number of Participants with Clinically Significant Hematomas"},{"nctId":"NCT06379724","phase":"PHASE4","title":"Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft","status":"RECRUITING","sponsor":"University of Kansas Medical Center","startDate":"2024-07-11","conditions":"Burns, Skin Graft Complications","enrollment":62,"completionDate":"2026-12","primaryEndpoint":"The number of participants with hematoma occurrence"},{"nctId":"NCT05807074","phase":"PHASE4","title":"Impact of Topical Tranexamic Acid in Breast Reconstruction","status":"TERMINATED","sponsor":"University of California, San Francisco","startDate":"2023-04-20","conditions":"Breast Cancer","enrollment":23,"completionDate":"2024-11-30","primaryEndpoint":"Number of Breast Pockets That Develop a Hematoma"},{"nctId":"NCT07192640","phase":"NA","title":"Intravenous Tranexamic Acid","status":"NOT_YET_RECRUITING","sponsor":"Ain Shams University","startDate":"2025-10-15","conditions":"Obese Patients, Obese Patients With Bariatric Surgery, Bleeding","enrollment":128,"completionDate":"2026-03-30","primaryEndpoint":"Intraoperative blood Loss"},{"nctId":"NCT07184528","phase":"NA","title":"PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks","status":"RECRUITING","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2025-07-01","conditions":"Persistent Air Leaks","enrollment":20,"completionDate":"2027-07-01","primaryEndpoint":"Incidence of Adverse Events Following Combined Blood Patch and Spiration Valve Application"},{"nctId":"NCT07187258","phase":"PHASE4","title":"the Use of Tranexamic Acid to Prevent the Bleeding in Bariatric Surgery","status":"COMPLETED","sponsor":"Cairo University","startDate":"2024-07-01","conditions":"Haemorrhage, Bariatric Surgery Candidate","enrollment":132,"completionDate":"2025-07-01","primaryEndpoint":"intraoperative estimated blood loss (EBL"},{"nctId":"NCT06653699","phase":"NA","title":"Effectiveness of Peri-operative Combined Use of 2 Doses of Dexamethasone With Tranexamic Acid in Lower Limb Joint Replacements-A Randomized Controlled Trial.","status":"COMPLETED","sponsor":"Indus Hospital and Health Network","startDate":"2024-07-11","conditions":"Hip Replacement, Knee Replacement","enrollment":92,"completionDate":"2025-07-20","primaryEndpoint":"C-reactive protein"},{"nctId":"NCT06599762","phase":"PHASE2","title":"Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"University of Manitoba","startDate":"2025-09-10","conditions":"Myelodysplastic Syndromes, Acute Myeloid Leukemia","enrollment":75,"completionDate":"2027-04-01","primaryEndpoint":"Patient enrollment feasibility"},{"nctId":"NCT07174895","phase":"NA","title":"Tranexamic Acid and Drain Use in Knee Arthroplasty","status":"COMPLETED","sponsor":"Idlib University","startDate":"2021-08-06","conditions":"Osteoarthritis, Knee","enrollment":192,"completionDate":"2025-04-01","primaryEndpoint":"Total Blood Loss"},{"nctId":"NCT07169383","phase":"PHASE2","title":"Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma","status":"ENROLLING_BY_INVITATION","sponsor":"Hina Malik","startDate":"2025-06-28","conditions":"Melasma (Facial Melasma)","enrollment":160,"completionDate":"2025-12-28","primaryEndpoint":"Total participants are 160, 80 in Group A and 80 in Group B"},{"nctId":"NCT05311033","phase":"NA","title":"Evaluation of a Tranexamoc Acid Treatment on Post-inflammatory Pigmentation in the Suction Blister Model","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Nice","startDate":"2023-01-04","conditions":"Skin Pigmentation","enrollment":10,"completionDate":"2025-08-18","primaryEndpoint":"Change from Baseline post-inflammatory hyperpigmentation induced in the suction blister model Systolic Blood Pressure at 6 months"},{"nctId":"NCT07164300","phase":"NA","title":"Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery","status":"RECRUITING","sponsor":"University of Ioannina","startDate":"2024-05-14","conditions":"Blood Coagulation Disorder, Postoperative Blood Loss, Adverse Drug Event","enrollment":150,"completionDate":"2027-12-15","primaryEndpoint":"duration of inhibition of fibrinolysis as measured by the ClotPro-TPA test"},{"nctId":"NCT04233749","phase":"PHASE2","title":"The Efficacy of Tranexamic Acid in the Treatment of Lichen Planus Pigmentosus and Erythema Dyschromicum Perstans","status":"RECRUITING","sponsor":"Henry Ford Health System","startDate":"2020-03-17","conditions":"Lichen Planus Pigmentosus, Erythema Dyschromicum Perstans, Ashy Dermatosis of Ramirez","enrollment":5,"completionDate":"2025-12-30","primaryEndpoint":"Change in Pigmentation using Colorimetry"},{"nctId":"NCT06434636","phase":"NA","title":"The Effect of Tranexamic Acid in Endoscopic and Microscopic Ear Surgery Cases on Surgeon Satisfaction","status":"COMPLETED","sponsor":"TC Erciyes University","startDate":"2024-12-01","conditions":"Middle Ear Disease","enrollment":100,"completionDate":"2025-08-06","primaryEndpoint":"Boezaart et al grading scale"},{"nctId":"NCT06369012","phase":"NA","title":"Management of Abnormal Uterine Bleeding","status":"COMPLETED","sponsor":"Egymedicalpedia","startDate":"2024-03-01","conditions":"Abnormal Uterine Bleeding","enrollment":130,"completionDate":"2024-09-30","primaryEndpoint":"Bleeding Control"},{"nctId":"NCT04562610","phase":"PHASE2, PHASE3","title":"Enhanced Recovery After Surgery in Orthopaedic Spine Surgery","status":"COMPLETED","sponsor":"University of California, Davis","startDate":"2020-11-18","conditions":"Lumbar Surgery","enrollment":33,"completionDate":"2024-10-09","primaryEndpoint":"Operative blood loss (ml)"},{"nctId":"NCT06057675","phase":"PHASE2","title":"Tranexamic Acid in Nasal Mohs Reconstruction","status":"RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2024-03-19","conditions":"Postoperative Bleeding, Skin Cancer Face","enrollment":100,"completionDate":"2026-06","primaryEndpoint":"Surgical site swelling and bruising (surgeon)"},{"nctId":"NCT06000423","phase":"PHASE4","title":"Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects","status":"COMPLETED","sponsor":"Oregon Health and Science University","startDate":"2024-01-23","conditions":"Bleeding, Contraceptive Device; Complications","enrollment":65,"completionDate":"2025-08-14","primaryEndpoint":"Amenorrhea days"},{"nctId":"NCT06345833","phase":"EARLY_PHASE1","title":"Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study","status":"RECRUITING","sponsor":"University of Minnesota","startDate":"2024-07-01","conditions":"Hemophilia, Hemorrhage, Facelift Surgery","enrollment":50,"completionDate":"2026-07-01","primaryEndpoint":"Blood loss"},{"nctId":"NCT05464459","phase":"NA","title":"Pyrocarbon Interposition Arthroplasty of the Elbow","status":"ACTIVE_NOT_RECRUITING","sponsor":"Wrightington, Wigan and Leigh NHS Foundation Trust","startDate":"2022-10-17","conditions":"Osteoarthritis of Elbow","enrollment":8,"completionDate":"2026-12-31","primaryEndpoint":"Safety and acceptability"},{"nctId":"NCT07125508","phase":"PHASE2, PHASE3","title":"Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias","status":"COMPLETED","sponsor":"Louisiana State University Health Sciences Center in New Orleans","startDate":"2023-08-01","conditions":"Anemia, Small Bowel Bleeding, Angioectasias","enrollment":40,"completionDate":"2024-12-15","primaryEndpoint":"Number of participants with improved hemoglobin concentrations and/or blood transfusions requirement"},{"nctId":"NCT06208267","phase":"NA","title":"Tranexamic Acid Use on Pain, Mobility and Bleeding Following Total Hip and Total Knee Arthroplasty","status":"RECRUITING","sponsor":"St. Mary's Research Center, Canada","startDate":"2025-08-20","conditions":"Postoperative Bleeding","enrollment":210,"completionDate":"2027-04","primaryEndpoint":"Step counts at 24 and 48 hours post -operative"},{"nctId":"NCT07123805","phase":"NA","title":"ACU_Knee: Role of Acupuncture in Knee Prosthetic Surgery","status":"RECRUITING","sponsor":"Fondazione IRCCS Policlinico San Matteo di Pavia","startDate":"2024-04-10","conditions":"Acupuncture Analgesia, Acupuncture, Acupuncture Therapy","enrollment":80,"completionDate":"2026-12-31","primaryEndpoint":"Quantity of opioid rescue medication taken by the patient"},{"nctId":"NCT03063892","phase":"PHASE4","title":"Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion","status":"RECRUITING","sponsor":"Gregory M Georgiadis MD","startDate":"2017-08-30","conditions":"Hip Fractures","enrollment":200,"completionDate":"2026-09-01","primaryEndpoint":"proportion of patients requiring packed Red Blood Cell transfusion"},{"nctId":"NCT04910464","phase":"PHASE3","title":"Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis","status":"RECRUITING","sponsor":"Assiut University","startDate":"2021-06-05","conditions":"Sepsis","enrollment":80,"completionDate":"2027-01-30","primaryEndpoint":"ICU mortality"},{"nctId":"NCT06820177","phase":"PHASE4","title":"Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes","status":"RECRUITING","sponsor":"University of California, San Diego","startDate":"2025-04-22","conditions":"Abortion, Dilation and Evacuation, Hemorrhage","enrollment":276,"completionDate":"2026-05","primaryEndpoint":"Composite outcome of excessive bleeding"},{"nctId":"NCT07098780","phase":"PHASE4","title":"Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery","status":"RECRUITING","sponsor":"Patel Hospital, Pakistan","startDate":"2023-06-12","conditions":"Hemorrhage, Bariatric Surgery, Obesity, Morbid","enrollment":140,"completionDate":"2025-08-31","primaryEndpoint":"Need for additional intervention intra operative after administration of transamine"},{"nctId":"NCT06145191","phase":"NA","title":"Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy","status":"COMPLETED","sponsor":"Clinical Hospital Centre Zagreb","startDate":"2023-12-18","conditions":"Bleeding, Hemoptysis","enrollment":1013,"completionDate":"2025-03-28","primaryEndpoint":"Number (N) of bleeding episodes / bleeding rate (%) in each group"},{"nctId":"NCT07094399","phase":"","title":"Tranexamic Acid for Postpartum Vaginal Laceration Hemorrhage","status":"COMPLETED","sponsor":"Harran University","startDate":"2024-01-01","conditions":"Postpartum Hemorrhage, Vaginal Lacerations","enrollment":161,"completionDate":"2024-11-30","primaryEndpoint":"Total Postpartum Blood Loss"},{"nctId":"NCT04117243","phase":"PHASE2","title":"Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During Elective CS in High Risk Cases","status":"COMPLETED","sponsor":"Cairo University","startDate":"2020-01-20","conditions":"Post Partum Hemorrhage","enrollment":345,"completionDate":"2020-12-31","primaryEndpoint":"o compare the estimated blood loss (EBL) during cesarean delivery among the three groups"},{"nctId":"NCT07089251","phase":"PHASE4","title":"The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery","status":"RECRUITING","sponsor":"King Abdullah International Medical Research Center","startDate":"2025-07-15","conditions":"Knee Arthroplasty, Total, Knee Arthritis, Osteoarthritis, Total Knee Anthroplasty","enrollment":80,"completionDate":"2027-06-24","primaryEndpoint":"Perioperative blood loss"},{"nctId":"NCT07078942","phase":"PHASE4","title":"Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section","status":"NOT_YET_RECRUITING","sponsor":"Chulalongkorn University","startDate":"2025-07-20","conditions":"Pregnant Women Undergoing Cesarean Delivery","enrollment":98,"completionDate":"2026-12-31","primaryEndpoint":"Blood loss"},{"nctId":"NCT04785651","phase":"NA","title":"Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies","status":"TERMINATED","sponsor":"Istituto Ortopedico Rizzoli","startDate":"2021-02-22","conditions":"Monocompartimental Tibiofemoral Osteoarthritis, Osteoarthritis","enrollment":49,"completionDate":"2025-05-09","primaryEndpoint":"Perioperative blood loss (haemoglobin balance):"},{"nctId":"NCT06421389","phase":"NA","title":"Precise Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Bleeding: A Randomized Controlled Trial","status":"COMPLETED","sponsor":"National Cheng-Kung University Hospital","startDate":"2024-08-15","conditions":"Bleed Ulcer","enrollment":60,"completionDate":"2025-06-30","primaryEndpoint":"the recurrent rate of GI bleeding during the study period"},{"nctId":"NCT05302986","phase":"PHASE3","title":"Effect on Post-operative Pain of Tranexamic Acid Injection During Shoulder Surgery","status":"RECRUITING","sponsor":"Elsan","startDate":"2023-02-24","conditions":"Shoulder Disease","enrollment":220,"completionDate":"2025-09","primaryEndpoint":"Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no)."},{"nctId":"NCT05713630","phase":"PHASE3","title":"The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma","status":"NOT_YET_RECRUITING","sponsor":"Unity Health Toronto","startDate":"2025-09-30","conditions":"Subdural Hematoma","enrollment":130,"completionDate":"2030-12-31","primaryEndpoint":"European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)"},{"nctId":"NCT06425614","phase":"NA","title":"COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial","status":"RECRUITING","sponsor":"University Hospital, Bordeaux","startDate":"2024-07-15","conditions":"On-pump Cardiac Surgery, High Risk for Bleeding, Autotransfusion","enrollment":570,"completionDate":"2026-02-15","primaryEndpoint":"Perioperative bleeding"},{"nctId":"NCT06970483","phase":"","title":"Comparison of the Efficacy of Misoprostol and Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery","status":"COMPLETED","sponsor":"Ankara Etlik City Hospital","startDate":"2023-12-01","conditions":"Postpartum Hemorrhage, Cesarean Section Complications, Delivery Complication","enrollment":150,"completionDate":"2024-12-01","primaryEndpoint":"Comparison of patients' preoperative and postoperative hemogram levels"},{"nctId":"NCT07034560","phase":"PHASE4","title":"Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Thammasat University","startDate":"2024-11-12","conditions":"Melasma, Treatment Outcome, Recurrence","enrollment":75,"completionDate":"2025-11-06","primaryEndpoint":"Change in modified Melasma Area and Severity Index (mMASI)"},{"nctId":"NCT06806241","phase":"","title":"Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery","status":"RECRUITING","sponsor":"Bezmialem Vakif University","startDate":"2025-01-01","conditions":"Bleeding, Tooth Extraction","enrollment":20,"completionDate":"2026-03-10","primaryEndpoint":"postoperative edema"},{"nctId":"NCT07015359","phase":"","title":"Renal Functions in Preeclamptic Pregnant Women Using Neutrophil Gelatinase-associated Lipocalin (NGAL) and Standard Renal Function Tests","status":"NOT_YET_RECRUITING","sponsor":"Nihan Aydin Guzey","startDate":"2025-06-08","conditions":"Anesthesia, Spinal Aneshtesia, Acute Kidney Failure","enrollment":46,"completionDate":"2025-10-20","primaryEndpoint":"ID: TABED 2/170/2024 Change in Plasma NGAL Levels Before and After Spinal Anesthesia"},{"nctId":"NCT07013812","phase":"PHASE4","title":"Tranexamic Acid to Reduce Blood Loss in Women Having Planned Cesarean Section","status":"COMPLETED","sponsor":"Combined Military Hospital Multan","startDate":"2023-11-01","conditions":"Cesarean Section, Blood Loss During Surgery","enrollment":68,"completionDate":"2024-04-30","primaryEndpoint":"Blood Loss"},{"nctId":"NCT03598907","phase":"","title":"Point-of-care Management of Coagulopathy in Lung Transplantation","status":"TERMINATED","sponsor":"University Hospital, Motol","startDate":"2018-01-01","conditions":"Lung Transplantation","enrollment":100,"completionDate":"2020-06-30","primaryEndpoint":"Perioperative Blood Loss"},{"nctId":"NCT06128330","phase":"PHASE4","title":"Point-of-care Measurement of the Antifibrinolytic Activity of Tranexamic Acid in Cardiac Surgery","status":"RECRUITING","sponsor":"Insel Gruppe AG, University Hospital Bern","startDate":"2023-12-15","conditions":"Antifibrinolytic Agents","enrollment":322,"completionDate":"2026-12-31","primaryEndpoint":"TPA test"},{"nctId":"NCT07005661","phase":"PHASE2, PHASE3","title":"Use of PRP in Open Surgery for Type A Aortic Dissection","status":"NOT_YET_RECRUITING","sponsor":"Beijing Anzhen Hospital","startDate":"2025-06-30","conditions":"Aortic Dissection Type A, Transfusions, Platelet Rich Plasma (PRP)","enrollment":250,"completionDate":"2028-10-31","primaryEndpoint":"Units of Allogeneic RBC Transfusion Within 24 Hours Perioperatively"},{"nctId":"NCT07002749","phase":"PHASE1","title":"ROLE OF PROPHYLACTIC TRANEXAMIC ACID IN PREVENTION OF POST-PARTUM HEMORRHAGE IN ELLSCS","status":"NOT_YET_RECRUITING","sponsor":"Patel Hospital, Pakistan","startDate":"2025-06-01","conditions":"Post Partum Hemorrhage","enrollment":104,"completionDate":"2025-12-31","primaryEndpoint":"prophylactic tranexamic acid in prevention of post-partum haemorrhage in ELLSCS"},{"nctId":"NCT06997796","phase":"PHASE1, PHASE2","title":"Treatment of Nosebleeds in the Emergency Department With Powder Tranexamic Acid","status":"RECRUITING","sponsor":"Dr. Anne Conlin","startDate":"2025-05","conditions":"Epistaxis Nosebleed","enrollment":24,"completionDate":"2025-12","primaryEndpoint":"Cessation of epistaxis"},{"nctId":"NCT06107504","phase":"NA","title":"Prevention of Post-sphincterotomy Bleeding","status":"RECRUITING","sponsor":"National Cheng-Kung University Hospital","startDate":"2024-01-01","conditions":"Post-ERCP Bleeding","enrollment":120,"completionDate":"2025-07-31","primaryEndpoint":"The incident rate of delayed post-ERCP bleeding during the study period"},{"nctId":"NCT04347122","phase":"PHASE4","title":"Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction","status":"TERMINATED","sponsor":"University of Kansas Medical Center","startDate":"2020-01-28","conditions":"Musculoskeletal Cancer, Sarcoma,Soft Tissue","enrollment":12,"completionDate":"2023-08-18","primaryEndpoint":"Perioperative Blood Loss"},{"nctId":"NCT06983886","phase":"PHASE1, PHASE2","title":"The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery","status":"NOT_YET_RECRUITING","sponsor":"Ramathibodi Hospital","startDate":"2025-05-12","conditions":"Postoperative Blood Loss in Patient Undergoing Orthognathic Surgery","enrollment":25,"completionDate":"2026-09-30","primaryEndpoint":"Postoperative blood loss"},{"nctId":"NCT03553186","phase":"PHASE3","title":"Tranexamic Acid in Adult Spinal Deformity Surgery","status":"RECRUITING","sponsor":"Hospital for Special Surgery, New York","startDate":"2018-07-11","conditions":"Spinal Deformity, Degenerative Lumbar Spinal Stenosis, Blood Loss, Surgical","enrollment":100,"completionDate":"2026-03","primaryEndpoint":"Postoperative Drain output"},{"nctId":"NCT05490186","phase":"NA","title":"Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis","status":"TERMINATED","sponsor":"North York General Hospital","startDate":"2021-11-16","conditions":"Knee Replacement, Total, Pain, Postoperative, Functional Independence","enrollment":261,"completionDate":"2024-02-08","primaryEndpoint":"Function"},{"nctId":"NCT06718751","phase":"PHASE2","title":"Tranexamic Acid Therapy For The Treatment of Subdural Hematomas","status":"NOT_YET_RECRUITING","sponsor":"Baylor College of Medicine","startDate":"2025-10","conditions":"Chronic Subdural Hematoma","enrollment":240,"completionDate":"2030-10","primaryEndpoint":"Rate of resolution measured as the cSDH volume or diameter"},{"nctId":"NCT04760301","phase":"NA","title":"Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss","status":"RECRUITING","sponsor":"Meir Medical Center","startDate":"2021-02-16","conditions":"Blood Loss","enrollment":60,"completionDate":"2026-06","primaryEndpoint":"Blood loss during operation - measure in ml"},{"nctId":"NCT05260320","phase":"NA","title":"Anesthetic Optimization in Pediatric LeFort Surgeries","status":"RECRUITING","sponsor":"Johns Hopkins University","startDate":"2025-05-02","conditions":"Le Fort, Pain, Postoperative","enrollment":50,"completionDate":"2027-07","primaryEndpoint":"Postoperative pain"},{"nctId":"NCT06644079","phase":"PHASE2","title":"Window of Opportunity Study of Topical Tranexamic Acid for Cutaneous Squamous Cell Carcinoma","status":"WITHDRAWN","sponsor":"University of Florida","startDate":"2025-05","conditions":"Cutaneous Squamous Cell Carcinoma","enrollment":0,"completionDate":"2026-04","primaryEndpoint":"Percentage of subjects who have a reduction in tumor size"},{"nctId":"NCT06648265","phase":"PHASE4","title":"EFFECTS OF TRANEXAMIC ACID IN TUMESCENT SOLUTION FOR LIPOSUCTION PROCEDURES","status":"COMPLETED","sponsor":"Total Definer Research Group","startDate":"2022-01-20","conditions":"Liposuction, Bruising, Inflammation","enrollment":78,"completionDate":"2024-06-13","primaryEndpoint":"Ecchymosis of the arms"},{"nctId":"NCT06657924","phase":"PHASE2","title":"Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery","status":"RECRUITING","sponsor":"Kristen Ban","startDate":"2025-02-11","conditions":"Bleeding, Colorectal Disorders, Thromboembolism","enrollment":394,"completionDate":"2026-10-01","primaryEndpoint":"Perioperative change in hemoglobin"},{"nctId":"NCT02314988","phase":"PHASE2, PHASE3","title":"Tranexamic Acid to Reduce Blood Loss in Spine Surgery","status":"RECRUITING","sponsor":"Columbia University","startDate":"2020-06-15","conditions":"Spinal Injuries, Spinal Deformity","enrollment":252,"completionDate":"2026-07","primaryEndpoint":"Maximal drop in systemic hemoglobin concentration during the postoperative period"},{"nctId":"NCT04341662","phase":"NA","title":"A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth","status":"COMPLETED","sponsor":"University of Birmingham","startDate":"2020-10-13","conditions":"Post-Partum Haemorrhage","enrollment":99659,"completionDate":"2023-03-24","primaryEndpoint":"The Primary Outcome is a Composite of the Following Three Clinical Outcomes: 1) Severe PPH Defined as Blood Loss ≥1000 ml or; 2) Postpartum Laparotomy for Bleeding or; 3) Postpartum Maternal Death Fro"},{"nctId":"NCT04625530","phase":"PHASE3","title":"Perioperative Management in Gynaecological Carcinoma Surgery","status":"WITHDRAWN","sponsor":"University Hospital, Basel, Switzerland","startDate":"2021-08-01","conditions":"Gynaecological Carcinoma","enrollment":0,"completionDate":"2026-12-31","primaryEndpoint":"number of all perioperative (intraoperative and postoperative) administered RBC transfusions"},{"nctId":"NCT05774717","phase":"PHASE1","title":"Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis","status":"RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2023-04-01","conditions":"Surgery, Postoperative Blood Loss","enrollment":60,"completionDate":"2026-02-01","primaryEndpoint":"Intraoperative bleeding as measured by the weight of surgical sponges used"},{"nctId":"NCT06920264","phase":"PHASE1","title":"Effect of Tranexamic Acid (TXA) Administered Prior to Shoulder Arthroscopy on Postoperative Pain Medication Usage: A Randomized Controlled Trial","status":"COMPLETED","sponsor":"St. Louis Joint Replacement Institute","startDate":"2021-07-01","conditions":"This Study Will Evaluate Whether TXA Reduces Pain","enrollment":165,"completionDate":"2024-09-30","primaryEndpoint":"primary outcome measure will be postoperative opioid consumption as measured by pill count for 72 hours, calculated as morphine equivalent dose (MED)."},{"nctId":"NCT06903299","phase":"","title":"Prospective Investigation of Intra-Articular Tranexamic Acid Use in Elective Hip Arthroplasty","status":"RECRUITING","sponsor":"St. Anne's University Hospital Brno, Czech Republic","startDate":"2023-01-01","conditions":"Blood Loss, Hemoglobin Change, Blood Transfusion","enrollment":1000,"completionDate":"2026-12-31","primaryEndpoint":"Postoperative Blood Loss"},{"nctId":"NCT04797156","phase":"EARLY_PHASE1","title":"Combined IV and Topical TXA in Major Spine Surgery","status":"COMPLETED","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2021-03-03","conditions":"Spine Surgery, Back Pain","enrollment":65,"completionDate":"2024-08-15","primaryEndpoint":"Change in Hematocrit level"},{"nctId":"NCT05357079","phase":"EARLY_PHASE1","title":"Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin/Hematocrit","status":"COMPLETED","sponsor":"University of Cincinnati","startDate":"2017-08-25","conditions":"Fracture of Posterior Wall of Acetabulum","enrollment":94,"completionDate":"2024-12-02","primaryEndpoint":"Hemoglobin (Hb)"},{"nctId":"NCT06384456","phase":"PHASE4","title":"Topical TRanexamic Acid Vs. Placebo on Acute Postoperative Pain Following DRF Fixation","status":"NOT_YET_RECRUITING","sponsor":"University Health Network, Toronto","startDate":"2025-03","conditions":"Distal Radius Fractures","enrollment":90,"completionDate":"2026-09","primaryEndpoint":"acute post-op pain"},{"nctId":"NCT05811676","phase":"PHASE3","title":"Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa","status":"COMPLETED","sponsor":"Guangzhou Medical University","startDate":"2023-07-12","conditions":"Hemorrhage, Postpartum, Placenta Previa","enrollment":1732,"completionDate":"2025-03-23","primaryEndpoint":"Incidence of PPH"},{"nctId":"NCT03287336","phase":"PHASE2","title":"Prevention of Postpartum Hemorrhage With Tranexamic Acid","status":"COMPLETED","sponsor":"George Washington University","startDate":"2018-01-02","conditions":"Postpartum Hemorrhage","enrollment":43,"completionDate":"2023-09-30","primaryEndpoint":"PK Model Parameter Estimates"},{"nctId":"NCT06879353","phase":"NA","title":"Comparison of Single-Dose Tranexamic Acid Vs. Placebo in Ovarian Cancer Surgery","status":"COMPLETED","sponsor":"Sheikh Zayed Medical College","startDate":"2023-07-12","conditions":"Ovarian Cancer, Perioperative Blood Loss, Blood Transfusion Events","enrollment":372,"completionDate":"2024-07-12","primaryEndpoint":"Requirement of Blood Transfusion After Surgery"},{"nctId":"NCT04742205","phase":"PHASE2, PHASE3","title":"ITCH Trial: Protocol for a Randomized, Double Blind Placebo-controlled Trial","status":"COMPLETED","sponsor":"Kathmandu Medical College and Teaching Hospital","startDate":"2021-02-08","conditions":"Cerebral Hemorrhage","enrollment":154,"completionDate":"2024-06-04","primaryEndpoint":"Radiological improvement (CT scan)"},{"nctId":"NCT05899465","phase":"PHASE3","title":"Perioperative Treatment With Tranexamic Acid in Melanoma","status":"RECRUITING","sponsor":"University of Aarhus","startDate":"2023-08-25","conditions":"Melanoma","enrollment":1204,"completionDate":"2028-09-01","primaryEndpoint":"Difference in rate of relapse within two years when comparing treatment arms"},{"nctId":"NCT06881628","phase":"PHASE4","title":"Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients","status":"RECRUITING","sponsor":"Tanta University","startDate":"2024-12-02","conditions":"Upper Gastrointestinal Bleeding (UGIB), Variceal Bleeding, Cirrhosis","enrollment":194,"completionDate":"2025-12-30","primaryEndpoint":"Rebleeding rate"},{"nctId":"NCT06205615","phase":"PHASE2","title":"Treatment of Post-Punch Biopsy Bleeding in Apixaban-Treated Patients Using Self-Administered BXP154B","status":"COMPLETED","sponsor":"Bio 54, LLC","startDate":"2024-01-24","conditions":"Wound Bleeding","enrollment":24,"completionDate":"2024-03-18","primaryEndpoint":"Time to achieve hemostasis (in minutes) following start of treatment"},{"nctId":"NCT06754371","phase":"PHASE4","title":"Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage","status":"RECRUITING","sponsor":"RenJi Hospital","startDate":"2025-01-06","conditions":"Postpartum Hemorrhage, Systemic Autoimmune Diseases","enrollment":276,"completionDate":"2027-06","primaryEndpoint":"The incidence of postpartum hemorrhage"},{"nctId":"NCT06876181","phase":"","title":"In Vivo Study of Local Tranexamic Acid Concentrations Following Intra-Articular Administration in Total Knee Arthroplasty","status":"COMPLETED","sponsor":"Valdoltra Orthopedic Hospital","startDate":"2022-08-23","conditions":"Local Concentration of Tranexamic Acid Following Intra-articular Administration in TKA","enrollment":48,"completionDate":"2024-09-30","primaryEndpoint":"Tranexamic acid concentrations in periarticular hematoma at 0.5, 1.5, 3, 6, and 9 hours following a standard intra-articular injection of 2 g of tranexamic acid"},{"nctId":"NCT04278404","phase":"","title":"Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","status":"RECRUITING","sponsor":"Duke University","startDate":"2020-03-05","conditions":"Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children","enrollment":5000,"completionDate":"2027-09","primaryEndpoint":"Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling"},{"nctId":"NCT05562609","phase":"PHASE3","title":"Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk","status":"RECRUITING","sponsor":"London School of Hygiene and Tropical Medicine","startDate":"2024-04-22","conditions":"Postpartum Hemorrhage","enrollment":30000,"completionDate":"2025-09","primaryEndpoint":"Risk of Postpartum haemorrhage"},{"nctId":"NCT06865911","phase":"PHASE4","title":"Cold Versus Warm Tumescent Solution in Arm Liposculpture","status":"COMPLETED","sponsor":"Eternal Beauty SAS","startDate":"2023-01-12","conditions":"Arm Pain, Arm Aesthetics, Liposuction","enrollment":52,"completionDate":"2024-06-30","primaryEndpoint":"Ecchymosis"},{"nctId":"NCT04595786","phase":"NA","title":"The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection","status":"COMPLETED","sponsor":"Beijing Tiantan Hospital","startDate":"2020-10-30","conditions":"Seizures, Meningioma","enrollment":228,"completionDate":"2024-07-11","primaryEndpoint":"Early postoperative seizures within 7 days"},{"nctId":"NCT06246422","phase":"NA","title":"Tranexamic Acid Instillation in Laparoscopic Cholecystectomy","status":"COMPLETED","sponsor":"Tanta University","startDate":"2021-12-11","conditions":"Postoperative Complications","enrollment":91,"completionDate":"2022-12-13","primaryEndpoint":"Hematocrit concentration in the drain"},{"nctId":"NCT05554211","phase":"PHASE2","title":"Tranexamic Acid Usage in Bilateral Mastectomy to Reduce Post-surgical Drainage","status":"WITHDRAWN","sponsor":"Northwestern University","startDate":"2022-07-12","conditions":"Breast Cancer, BRCA Mutation","enrollment":0,"completionDate":"2024-07-01","primaryEndpoint":"Drain output"},{"nctId":"NCT03505723","phase":"PHASE3","title":"PeriOperative ISchemic Evaluation-3 Trial","status":"COMPLETED","sponsor":"Population Health Research Institute","startDate":"2018-06-27","conditions":"Perioperative Bleeding, Venous Thrombosis, Arterial Thrombosis","enrollment":9535,"completionDate":"2023-02-03","primaryEndpoint":"A composite of life-threatening bleeding, major bleeding, and critical organ bleeding"},{"nctId":"NCT06023212","phase":"PHASE1, PHASE2","title":"Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients","status":"RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2023-12-01","conditions":"Metastasis Spinal Tumor","enrollment":150,"completionDate":"2026-08-01","primaryEndpoint":"total blood loss"},{"nctId":"NCT06818630","phase":"NA","title":"Enhanced Photoaging Reversal Efficacy and Safety of 755nm Alexandrite Picosecond Laser with Diffractive Lens Array (DLA) in Conjunction with Integrated Skin Care for Skin Quality Improvement","status":"COMPLETED","sponsor":"L'Oréal Taiwan Co., Ltd","startDate":"2024-07-29","conditions":"Skin Quality Improvement","enrollment":35,"completionDate":"2025-01-23","primaryEndpoint":"The change of wrinkles, ultraviolet spots, brown spots, texture, pores, porphyrin, redness, blood vessels, hydration"},{"nctId":"NCT04304625","phase":"PHASE3","title":"TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA","status":"RECRUITING","sponsor":"University Hospital, Bordeaux","startDate":"2020-08-07","conditions":"Postpartum Hemorrhage","enrollment":1380,"completionDate":"2027-09","primaryEndpoint":"Incidence of red blood cell transfusion (binary outcome) between delivery of child and discharge from postpartum hospital stay."},{"nctId":"NCT05759156","phase":"NA","title":"Tranexamic Acid in Patients for Caesarian Delivery.","status":"COMPLETED","sponsor":"Dow University of Health Sciences","startDate":"2023-03-20","conditions":"Postpartum Hemorrhage, Cesarean Section Complications, Obstetric Anesthesia Problems","enrollment":572,"completionDate":"2024-02-10","primaryEndpoint":"Occurrence of postpartum haemorrhage (PPH)"},{"nctId":"NCT02561923","phase":"PHASE1","title":"A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants","status":"COMPLETED","sponsor":"Janssen Scientific Affairs, LLC","startDate":"2015-08-27","conditions":"Healthy","enrollment":158,"completionDate":"2016-06-17","primaryEndpoint":"Change From Baseline in Blood Volume in Part 1"},{"nctId":"NCT03714360","phase":"PHASE4","title":"The Effect of Tranexamic Acid. A Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.","status":"COMPLETED","sponsor":"Mikkel Østerheden Andersen","startDate":"2015-10-19","conditions":"Pharmacological Action","enrollment":250,"completionDate":"2016-08-16","primaryEndpoint":"Operative time"},{"nctId":"NCT06419075","phase":"PHASE4","title":"Tranexamic Acid in Vaginal Reconstructive Surgery","status":"WITHDRAWN","sponsor":"The University of Texas Medical Branch, Galveston","startDate":"2024-07-01","conditions":"Pelvic Organ Prolapse","enrollment":0,"completionDate":"2025-01-27","primaryEndpoint":"Intraoperative quantitative blood loss QBL (mL)"},{"nctId":"NCT06725732","phase":"EARLY_PHASE1","title":"Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score","status":"RECRUITING","sponsor":"Assiut University","startDate":"2025-01-29","conditions":"Blood Loss, Surgical","enrollment":90,"completionDate":"2026-01-01","primaryEndpoint":"Modena Bleeding Score- assessing surgical field"},{"nctId":"NCT06493227","phase":"NA","title":"Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery","status":"RECRUITING","sponsor":"Saint Petersburg State University, Russia","startDate":"2024-08-01","conditions":"Thoracic Surgery, Heart Diseases, Fibrinolysis Shutdown","enrollment":1373,"completionDate":"2026-06-01","primaryEndpoint":"RBC transfusion"},{"nctId":"NCT05688111","phase":"NA","title":"Tranexamic Acid as an Intervention in Placenta Previa","status":"COMPLETED","sponsor":"Hawler Medical University","startDate":"2022-12-10","conditions":"Interventional Drug in Placenta Previa","enrollment":146,"completionDate":"2023-12-03","primaryEndpoint":"To stope or decrease vaginal bleeding"},{"nctId":"NCT06777966","phase":"PHASE4","title":"Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries","status":"RECRUITING","sponsor":"Cairo University","startDate":"2025-01-18","conditions":"Nebulization, Intravenous, Surgical Field","enrollment":60,"completionDate":"2025-07-01","primaryEndpoint":"The mean Wormald intraoperative surgical field grading"},{"nctId":"NCT06781021","phase":"NA","title":"The Effect of Tranexamic Acid Vs Torniquet on Visual Clarity in Knee Arthroscopic ACL Reconstruction","status":"ENROLLING_BY_INVITATION","sponsor":"The University of The West Indies","startDate":"2024-11-01","conditions":"ACL Tears","enrollment":60,"completionDate":"2026-02-01","primaryEndpoint":"Grading TXA"},{"nctId":"NCT06763094","phase":"NA","title":"Efficacy of Calcium Dobesilate Versus Tranexamic Acid for Treating Heavy Menstrual Bleeding","status":"NOT_YET_RECRUITING","sponsor":"University of Health Sciences Lahore","startDate":"2025-01-05","conditions":"Menorrhagia, Abnormal Uterine Bleeding","enrollment":100,"completionDate":"2025-12","primaryEndpoint":"Reduction in Menstrual Blood Loss"},{"nctId":"NCT06760078","phase":"PHASE4","title":"Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage","status":"NOT_YET_RECRUITING","sponsor":"Xuanwu Hospital, Beijing","startDate":"2024-12-31","conditions":"Spontaneous Intracranial Hemorrhage, Hypertension","enrollment":532,"completionDate":"2026-07-01","primaryEndpoint":"modified Rankin Scale (mRS) of 0-3 at 90 days"},{"nctId":"NCT06684080","phase":"NA","title":"The Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery","status":"NOT_YET_RECRUITING","sponsor":"Dunjin Chen","startDate":"2025-01-01","conditions":"Cesarean Delivery","enrollment":52000,"completionDate":"2027-06-30","primaryEndpoint":"Incidence of PPH"},{"nctId":"NCT04089865","phase":"PHASE4","title":"Oral Versus Intravenous Tranexamic Acid","status":"COMPLETED","sponsor":"Hospital for Special Surgery, New York","startDate":"2019-09-17","conditions":"Blood Loss, Blood Transfusion","enrollment":400,"completionDate":"2021-11-10","primaryEndpoint":"Calculated Blood Loss"},{"nctId":"NCT04410042","phase":"PHASE3","title":"Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure","status":"TERMINATED","sponsor":"St. Jude Children's Research Hospital","startDate":"2021-01-29","conditions":"Cancer of the Bone, Limb Salvage","enrollment":15,"completionDate":"2024-01-16","primaryEndpoint":"To Evaluate the Difference in intra-or Post-operatively Transfused Blood Volume (mL/kg) for Patients Undergoing Limb Salvage Procedures of the Distal Femur or Proximal Tibia Who Are Randomized to Rece"},{"nctId":"NCT05474027","phase":"PHASE4","title":"Reducing Hypotensive Anesthesia Use with TXA During Orthognathic Surgery","status":"ENROLLING_BY_INVITATION","sponsor":"University of Alabama at Birmingham","startDate":"2022-11-11","conditions":"Hypotension During Surgery, Blood Loss, Surgical","enrollment":50,"completionDate":"2025-12","primaryEndpoint":"Surgeon's Analysis of Surgical Field Visualization"},{"nctId":"NCT05806346","phase":"NA","title":"Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery","status":"RECRUITING","sponsor":"Konkuk University Medical Center","startDate":"2023-08-01","conditions":"Heart Diseases, Vascular Diseases, Transfusion Related Complication","enrollment":764,"completionDate":"2025-06-30","primaryEndpoint":"postoperative bleeding"},{"nctId":"NCT06736860","phase":"PHASE4","title":"Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography","status":"RECRUITING","sponsor":"Nanfang Hospital, Southern Medical University","startDate":"2024-08-01","conditions":"Trauma Coagulopathy","enrollment":580,"completionDate":"2028-12-31","primaryEndpoint":"30-day all-cause mortality rate"},{"nctId":"NCT05802238","phase":"PHASE2","title":"Efficacy of Tranexamic Acid (TXA) in Humerus ORIF","status":"WITHDRAWN","sponsor":"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)","startDate":"2023-04-12","conditions":"Fracture Humerus","enrollment":0,"completionDate":"2024-11-25","primaryEndpoint":"Blood loss"},{"nctId":"NCT06479161","phase":"PHASE2","title":"Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty","status":"RECRUITING","sponsor":"Matthew Grosso, MD","startDate":"2024-06-10","conditions":"Postoperative Pain","enrollment":80,"completionDate":"2025-03-30","primaryEndpoint":"Visual Analogue Scale (VAS) Pain scores"},{"nctId":"NCT04272606","phase":"PHASE2","title":"TXA in Spinal Fusion","status":"COMPLETED","sponsor":"Catherine R. Olinger","startDate":"2020-08-01","conditions":"Degenerative Disc Disease","enrollment":123,"completionDate":"2023-06-12","primaryEndpoint":"Transfusion"},{"nctId":"NCT06728670","phase":"NA","title":"Pharmacokinetic Study of Tranexamic Acid","status":"RECRUITING","sponsor":"Zhejiang Cancer Hospital","startDate":"2024-11-20","conditions":"Ovarian Neoplasm Epithelial","enrollment":30,"completionDate":"2025-08-31","primaryEndpoint":"Elimination clearance rate (CL) of tranexamic acid"},{"nctId":"NCT05994989","phase":"","title":"Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery","status":"COMPLETED","sponsor":"Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital","startDate":"2023-08-14","conditions":"Postoperative Hemorrhage","enrollment":90,"completionDate":"2024-10-21","primaryEndpoint":"Postoperative hemorrhage"},{"nctId":"NCT05448456","phase":"PHASE4","title":"Use of Tranexamic Acid After Vaginal Delivery with Episiotomy a RCT Placebo Control Trail","status":"COMPLETED","sponsor":"Assuta Ashdod Hospital","startDate":"2022-07-25","conditions":"Episiotomy Wound, Anemia, Early Postpartum Hemorrhage","enrollment":150,"completionDate":"2024-09-01","primaryEndpoint":"Delta Hb levels"},{"nctId":"NCT06270407","phase":"PHASE4","title":"The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery","status":"RECRUITING","sponsor":"St. Olavs Hospital","startDate":"2024-10-01","conditions":"Surgical Complication","enrollment":3000,"completionDate":"2029-12-31","primaryEndpoint":"Postoperative re-bleeding"},{"nctId":"NCT06710327","phase":"PHASE4","title":"Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Aquablation","status":"NOT_YET_RECRUITING","sponsor":"Kaiser Permanente","startDate":"2025-01","conditions":"Benign Prostatic Hyperplasia","enrollment":56,"completionDate":"2025-08","primaryEndpoint":"Perioperative Hemoglobin Change"},{"nctId":"NCT06707051","phase":"PHASE2, PHASE3","title":"Effect of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin","status":"COMPLETED","sponsor":"District Headquarters Teaching Hospital Sahiwal","startDate":"2022-01-01","conditions":"Heavy. Mentrual Bleeding, Abormal utèrine Bleeding, Bleeding","enrollment":100,"completionDate":"2024-06-30","primaryEndpoint":"Reduction in blood loss"},{"nctId":"NCT06243575","phase":"NA","title":"Comparison of Outcomes Between Intraosseous Femoral and Tibial Injection in Simultaneous Bilateral Total Knee Arthroplasty Patients","status":"UNKNOWN","sponsor":"Department of Medical Services Ministry of Public Health of Thailand","startDate":"2024-02-01","conditions":"Pain, Postoperative","enrollment":20,"completionDate":"2024-12-31","primaryEndpoint":"Pain score (Visual analog scale)"},{"nctId":"NCT04541303","phase":"EARLY_PHASE1","title":"Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery","status":"COMPLETED","sponsor":"University of Missouri-Columbia","startDate":"2020-10-08","conditions":"Postoperative Wound Haemorrhage","enrollment":124,"completionDate":"2021-12-30","primaryEndpoint":"Frequency of Postoperative Hemorrhagic Complications"},{"nctId":"NCT04630886","phase":"EARLY_PHASE1","title":"Use of Tranexamic Acid in Reduction of Post-Op Complications in Mohs Micrographic Surgery","status":"TERMINATED","sponsor":"Riley McLean","startDate":"2021-06-16","conditions":"Skin Neoplasms","enrollment":34,"completionDate":"2024-01-16","primaryEndpoint":"Postoperative Complications"},{"nctId":"NCT06289478","phase":"NA","title":"Efficacy and Safety of Retrograde Intraarticular Injection, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Femoral Neck Fractured Patients Undergoing Cementless Bipolar Hemiarthroplasty","status":"RECRUITING","sponsor":"King Chulalongkorn Memorial Hospital","startDate":"2024-07-03","conditions":"Femoral Neck Fracture","enrollment":75,"completionDate":"2026-04","primaryEndpoint":"Rate of blood transfusion"},{"nctId":"NCT06604325","phase":"NA","title":"Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.","status":"RECRUITING","sponsor":"Aligarh Muslim University","startDate":"2024-10-01","conditions":"Post Partum Hemorrhage","enrollment":300,"completionDate":"2025-03-30","primaryEndpoint":"Perioperative blood loss"},{"nctId":"NCT02656472","phase":"PHASE4","title":"A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2016-02","conditions":"Pediatric Cardiac Surgery, Complication of Extracorporeal Circulation","enrollment":22,"completionDate":"2017-04","primaryEndpoint":"Inflammatory Markers/Cytokines"},{"nctId":"NCT05326997","phase":"NA","title":"Treatment of Melasma With Yellow Light Compared to Tranexamic Acid","status":"TERMINATED","sponsor":"University of Nove de Julho","startDate":"2023-05-01","conditions":"Melasma","enrollment":21,"completionDate":"2023-10-30","primaryEndpoint":"MASI (Melasma Area and Severity Index)"},{"nctId":"NCT06648369","phase":"NA","title":"Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial","status":"NOT_YET_RECRUITING","sponsor":"Insel Gruppe AG, University Hospital Bern","startDate":"2024-12-01","conditions":"Intra Cerebral Hemorrhage","enrollment":50,"completionDate":"2026-05-01","primaryEndpoint":"Recruitment"},{"nctId":"NCT06457360","phase":"EARLY_PHASE1","title":"Comparison of Chitosan, Ankaferd and Tranexamic Acid in Dental Extraction in Liver Pre-Transplant Children","status":"COMPLETED","sponsor":"British University In Egypt","startDate":"2023-11-15","conditions":"Liver Cirrhosis","enrollment":39,"completionDate":"2024-05-20","primaryEndpoint":"To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases"},{"nctId":"NCT06414031","phase":"PHASE3","title":"Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery","status":"RECRUITING","sponsor":"Ulrich Ronellenfitsch, MD","startDate":"2024-06-17","conditions":"Surgical Blood Loss, Transfusion-dependent Anemia, Abdomen Disease","enrollment":850,"completionDate":"2025-11-30","primaryEndpoint":"Transfusion necessity"}],"_emaApprovals":[{"date":"","name":"Cyklokapron","holder":"","status":"Authorised","rawText":"Skip to main content\nAn official website of the European Union\nHow do you know?\n\nWe use cookies on this website. 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