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PROTHROMBIN
Prothrombin is a protein involved in blood clotting. It is a precursor to thrombin, which converts fibrinogen into fibrin, forming a blood clot. However, there is no information available on a pharmaceutical product called 'prothrombin'. Therefore, this summary will be based on the general concept of prothrombin. In the context of a pharmaceutical product, it is likely that a prothrombin-related product would be used to treat bleeding disorders or prevent excessive bleeding.
At a glance
| Generic name | PROTHROMBIN |
|---|---|
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2023 |
Approved indications
Common side effects
- Anemia
- Procedural pain
- Wound complications
- Asthenia
- Dysuria
- Procedural vomiting
- Catheter site related reaction
Serious adverse events
- Death
- Thromboembolic events
- Cerebral infarction
- Pulmonary embolism
- Unstable angina
- Hemorrhage
- Acute respiratory failure
- Shock
- Subdural hemorrhage
- Myocardial ischemia
Key clinical trials
- Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy (NA)
- Monitoring of Anti-TFPI in Hemophilia
- An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
- Autologous Whole Blood Management for Transfusion Reduction in Adult Cardiac Surgery Patients (NA)
- Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) (PHASE3)
- Efficacy of Platelet-rich-Fibrin Gel in Patients With Chronic Leg Ulcers (EARLY_PHASE1)
- A Trial of Intraoperative Fibrin Sealant on Postoperative Recovery After Total Knee Replacement (PHASE4)
- Testing a New Treatment Strategy to Improve Secondary Stroke Prevention for Older Adults: The STROKE75+ Trial (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |