{"id":"fresh-frozen-plasma-ffp","safety":{"commonSideEffects":[{"rate":null,"effect":"Volume overload / Fluid overload"},{"rate":null,"effect":"Transfusion-related acute lung injury (TRALI)"},{"rate":null,"effect":"Allergic reaction"},{"rate":null,"effect":"Transfusion-transmitted infection (rare with modern screening)"},{"rate":null,"effect":"Hyperkalemia"}]},"_chembl":{"chemblId":"CHEMBL2108772","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"FFP is a blood product containing all vitamin K-dependent clotting factors (II, V, VII, X), fibrinogen, and other plasma proteins. It is used to correct multiple factor deficiencies when specific factor replacement is unavailable or impractical, or in cases of massive transfusion where dilutional coagulopathy occurs. FFP restores the ability of blood to clot by providing the missing coagulation cascade components.","oneSentence":"Fresh Frozen Plasma replaces deficient clotting factors and other plasma proteins to restore hemostatic function in patients with coagulopathy or massive bleeding.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:30:51.525Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Coagulopathy due to multiple clotting factor deficiencies"},{"name":"Massive transfusion and dilutional coagulopathy"},{"name":"Reversal of warfarin in emergency settings (when prothrombin complex concentrate unavailable)"},{"name":"Thrombotic thrombocytopenic purpura (TTP) plasma exchange"},{"name":"Deficiency of vitamin K-dependent factors"}]},"trialDetails":[{"nctId":"NCT07094087","phase":"PHASE3","title":"Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2025-09-15","conditions":"Complex Cardiovascular Surgery With Cardiopulmonary Bypass","enrollment":200},{"nctId":"NCT07032792","phase":"PHASE2","title":"Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery","status":"RECRUITING","sponsor":"Northwell Health","startDate":"2025-11-03","conditions":"Cardiac Disease, Surgery, Bleeding","enrollment":140},{"nctId":"NCT06062888","phase":"PHASE2, PHASE3","title":"FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial","status":"RECRUITING","sponsor":"Northwestern University","startDate":"2026-02-01","conditions":"Moderate to Severe Traumatic Brain Injury","enrollment":357},{"nctId":"NCT06429332","phase":"PHASE4","title":"International Care Bundle Evaluation in Cerebral Hemorrhage Research","status":"RECRUITING","sponsor":"Region Skane","startDate":"2025-01-07","conditions":"Intracerebral Hemorrhage, Intracerebral Haemorrhage, Intraventricular Hemorrhage","enrollment":3500},{"nctId":"NCT04794348","phase":"PHASE2","title":"Clinical Trial Assessing Non-Inferiority of Freeze Dried Plasma to Fresh Frozen Plasma in Reversing Warfarin","status":"WITHDRAWN","sponsor":"Vascular Solutions LLC","startDate":"2021-05","conditions":"Anticoagulant Reversal","enrollment":""},{"nctId":"NCT05069922","phase":"NA","title":"Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2022-02-17","conditions":"Burns","enrollment":59},{"nctId":"NCT04244981","phase":"PHASE4","title":"Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery","status":"RECRUITING","sponsor":"SHI Jia","startDate":"2023-10-25","conditions":"Cardiac Surgical Procedures","enrollment":820},{"nctId":"NCT07160426","phase":"PHASE2","title":"Study of Protection And Repair of Endothelial-glycocalyx in Sepsis","status":"NOT_YET_RECRUITING","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2025-11-01","conditions":"Sepsis","enrollment":45},{"nctId":"NCT06859307","phase":"NA","title":"Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Zagazig University","startDate":"2025-03-01","conditions":"Adhesive Peritoneal Band","enrollment":176},{"nctId":"NCT05542277","phase":"NA","title":"A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasma™) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement","status":"TERMINATED","sponsor":"PlasFree Ltd.","startDate":"2022-11-08","conditions":"Bleeding, Bypass Complication, Valve Replacement","enrollment":130},{"nctId":"NCT03444324","phase":"PHASE3","title":"Adjusted Fibrinogen Replacement Strategy","status":"COMPLETED","sponsor":"Biotest","startDate":"2018-04-03","conditions":"Bleeding Disorder, Hypofibrinogenemia; Acquired","enrollment":222},{"nctId":"NCT03458429","phase":"PHASE1, PHASE2","title":"Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older Individuals","status":"ENROLLING_BY_INVITATION","sponsor":"Dipnarine Maharaj","startDate":"2018-02-05","conditions":"Frailty","enrollment":30},{"nctId":"NCT06642493","phase":"NA","title":"Efficacy of Fresh Frozen Plasma (FFP) in Treating Thrombocytopenia in Dengue Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sheikh Hasina National Institute of Burn and Plastic Surgery","startDate":"2024-05-01","conditions":"Dengue Fever, Dengue Hemorrhagic Fever, Dengue Shock Syndrome","enrollment":300},{"nctId":"NCT06635707","phase":"","title":"Efficacy and Safety Study of Urapidil Alone or With Esmolol in Treating Acute Hypertensive Intracerebral Hemorrhage","status":"NOT_YET_RECRUITING","sponsor":"Qianfoshan Hospital","startDate":"2024-11-01","conditions":"Hypertensive Intracerebral Hemorrhage","enrollment":600},{"nctId":"NCT05819788","phase":"","title":"FFP Usage in Pediatric CV Surgery","status":"COMPLETED","sponsor":"University of Alberta","startDate":"2023-08-28","conditions":"Coagulopathy, Congenital Heart Disease","enrollment":431},{"nctId":"NCT06144099","phase":"PHASE4","title":"Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery","status":"UNKNOWN","sponsor":"Konkuk University Medical Center","startDate":"2024-03-01","conditions":"Prostate Cancer, Spine, Open, Hip Osteoarthritis","enrollment":154},{"nctId":"NCT06144125","phase":"PHASE4","title":"Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery","status":"UNKNOWN","sponsor":"Konkuk University Medical Center","startDate":"2024-03-01","conditions":"Cardiac Valve Disease","enrollment":152},{"nctId":"NCT00618098","phase":"PHASE3","title":"Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures","status":"COMPLETED","sponsor":"Octapharma","startDate":"2008-05","conditions":"Reversal of Anticoagulant Treatment","enrollment":200},{"nctId":"NCT03209258","phase":"NA","title":"The Third, Intensive Care Bundle With Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial","status":"COMPLETED","sponsor":"The George Institute for Global Health, China","startDate":"2017-12-12","conditions":"Cerebral Hemorrhage, Stroke, Hypertension","enrollment":7067},{"nctId":"NCT04174989","phase":"NA","title":"Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatment of Patients With Acute Upper Gastrointestinal Hemorrhage.","status":"COMPLETED","sponsor":"PlasFree Ltd.","startDate":"2020-10-24","conditions":"Acute Upper Gastrointestinal Hemorrhage, Acute Upper Gastrointestinal Bleeding","enrollment":53},{"nctId":"NCT04109144","phase":"PHASE2","title":"Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis","status":"WITHDRAWN","sponsor":"Montefiore Medical Center","startDate":"2019-11-11","conditions":"Liver Cirrhosis, Ascites Hepatic","enrollment":""},{"nctId":"NCT02557672","phase":"PHASE4","title":"PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2016-08","conditions":"Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures","enrollment":106},{"nctId":"NCT04589949","phase":"PHASE3","title":"Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study)","status":"TERMINATED","sponsor":"Erasmus Medical Center","startDate":"2020-10-12","conditions":"Covid19","enrollment":420},{"nctId":"NCT04374149","phase":"PHASE2","title":"Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS","status":"COMPLETED","sponsor":"Prisma Health-Upstate","startDate":"2020-04-30","conditions":"Cytokine Release Syndrome, COVID19","enrollment":20},{"nctId":"NCT04434001","phase":"PHASE2","title":"ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery","status":"TERMINATED","sponsor":"IRCCS Policlinico S. Donato","startDate":"2020-02-27","conditions":"Bleeding, Cardiac Defect, Surgery--Complications","enrollment":40},{"nctId":"NCT05063409","phase":"NA","title":"Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting","status":"COMPLETED","sponsor":"Shriners Hospitals for Children","startDate":"2010-09","conditions":"Burn Injury","enrollment":72},{"nctId":"NCT03784794","phase":"NA","title":"Patient Blood Management for Massive Obstetric Hemorrhage","status":"COMPLETED","sponsor":"Angel Augusto Perez Calatayud","startDate":"2018-11-01","conditions":"Post Partum Hemorrhage, Fibrinogenolysis; Hemorrhage, Fibrinogen; Deficiency, Acquired","enrollment":100},{"nctId":"NCT01716208","phase":"PHASE2","title":"Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma","status":"COMPLETED","sponsor":"Joseph Tuscano","startDate":"2013-01-14","conditions":"Chronic Lymphocytic Leukemia","enrollment":12},{"nctId":"NCT04869072","phase":"PHASE1","title":"Convalescent Plasma Therapy - Zurich Protocol","status":"COMPLETED","sponsor":"University of Zurich","startDate":"2020-04-29","conditions":"COVID-19","enrollment":30},{"nctId":"NCT02930226","phase":"PHASE1","title":"Ascending Doses of Autologous FDP vs FFP","status":"COMPLETED","sponsor":"U.S. Army Medical Research and Development Command","startDate":"2017-02-13","conditions":"Freeze Dried Plasma in Healthy Volunteers","enrollment":30},{"nctId":"NCT04231994","phase":"PHASE2","title":"Therapeutic Plasmaexchange in Early Septic Shock","status":"COMPLETED","sponsor":"Hannover Medical School","startDate":"2018-06-01","conditions":"Septic Shock","enrollment":40},{"nctId":"NCT04514575","phase":"","title":"Plasma Transfusion in Major Vascular Surgery","status":"COMPLETED","sponsor":"Naestved Hospital","startDate":"1997-01-01","conditions":"Aortic Aneurysm, Abdominal, Arterial Occlusive Diseases","enrollment":17000},{"nctId":"NCT03715348","phase":"PHASE2","title":"Trial of PCC Versus FFP in Patients Undergoing Heart Surgery","status":"COMPLETED","sponsor":"Queen Mary University of London","startDate":"2019-03-01","conditions":"Bleeding, Surgery, Transfusion","enrollment":50},{"nctId":"NCT04485169","phase":"NA","title":"Therapeutic Plasma Exchange for Coronavirus Disease-2019 Triggered Cytokine Release Storm;","status":"COMPLETED","sponsor":"UNICEF","startDate":"2020-04-01","conditions":"COVID-19, Cytokine Release Syndrome","enrollment":280},{"nctId":"NCT04492501","phase":"NA","title":"Investigational Treatments for COVID-19 in Tertiary Care Hospital of Pakistan","status":"COMPLETED","sponsor":"UNICEF","startDate":"2020-04-01","conditions":"Covid19, Cytokine Release Syndrome, Critical Illness","enrollment":600},{"nctId":"NCT02366845","phase":"PHASE4","title":"Prospective Validation of a Plasma Transfusion Dosing Algorithm in Patients With Chronic Liver Disease","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2012-06-27","conditions":"Liver Disease","enrollment":50},{"nctId":"NCT03202524","phase":"PHASE4","title":"Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis","status":"WITHDRAWN","sponsor":"Montefiore Medical Center","startDate":"2017-12","conditions":"Liver Cirrhosis, Ascites Hepatic","enrollment":""},{"nctId":"NCT03801135","phase":"NA","title":"Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation","status":"UNKNOWN","sponsor":"University Medical Centre Ljubljana","startDate":"2018-10-03","conditions":"Humoral Rejection, Guillain-Barre Syndrome, Miller Fisher Syndrome","enrollment":20},{"nctId":"NCT02567786","phase":"NA","title":"Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children","status":"COMPLETED","sponsor":"Cliniques universitaires Saint-Luc- Université Catholique de Louvain","startDate":"2015-10","conditions":"Congenital Heart Disease","enrollment":60},{"nctId":"NCT02774317","phase":"PHASE4","title":"Pilot Study to Compare Fresh Frozen Plasma With 24-Hour Plasma in Babies Up to Age Six Months","status":"WITHDRAWN","sponsor":"University of Chicago","startDate":"2017-10","conditions":"Blood Coagulation Disorders","enrollment":""},{"nctId":"NCT03699813","phase":"","title":"ROTEM Versus aPTT/PT in Pediatric Surgery","status":"COMPLETED","sponsor":"University Hospital, Motol","startDate":"2015-02-02","conditions":"Coagulation Defect; Bleeding","enrollment":45},{"nctId":"NCT01910675","phase":"PHASE4","title":"PCC and Fibrinogen Compared With FFP in PPH","status":"WITHDRAWN","sponsor":"Helsinki University Central Hospital","startDate":"2013-07","conditions":"Postpartum Haemorrhage","enrollment":""},{"nctId":"NCT00670774","phase":"PHASE1, PHASE2","title":"Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant","status":"COMPLETED","sponsor":"Mark Stegall","startDate":"2008-03","conditions":"Kidney Transplant","enrollment":31},{"nctId":"NCT02037373","phase":"","title":"Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation","status":"TERMINATED","sponsor":"Octapharma","startDate":"2015-08","conditions":"Coagulopathy, Endstage Liver Disease","enrollment":43},{"nctId":"NCT03354559","phase":"","title":"Trauma Associated Bleeding: Effectiveness of an Early Coagulation Support Protocol","status":"COMPLETED","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","startDate":"2011-01-01","conditions":"Major Trauma","enrollment":235},{"nctId":"NCT01053169","phase":"","title":"Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2010-05","conditions":"Coagulation Protein Disorders, Blood Loss, Surgical, Perioperative Care","enrollment":445},{"nctId":"NCT01903863","phase":"NA","title":"The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity","status":"COMPLETED","sponsor":"Duke University","startDate":"2013-07","conditions":"Extracorporeal Membrane Oxygenation","enrollment":31},{"nctId":"NCT00994045","phase":"PHASE4","title":"Fibrinogen as an Alternative to FFP in Aortic Surgery.","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2010-06","conditions":"Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair","enrollment":20},{"nctId":"NCT02253082","phase":"PHASE4","title":"Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2014-11","conditions":"Aortic Aneurysm, Thoracic, Endothelial Dysfunction","enrollment":44},{"nctId":"NCT02429453","phase":"NA","title":"FFP Versus PCC in Intracranial Hemorrhage","status":"WITHDRAWN","sponsor":"University of Utah","startDate":"2015-04","conditions":"Intracranial Hemorrhage, Traumatic, Intracranial Hemorrhage, Spontaneous","enrollment":""},{"nctId":"NCT00928915","phase":"PHASE4","title":"International Normalized Ratio (INR) Normalization in Coumadin Associated Intracerebral Haemorrhage","status":"COMPLETED","sponsor":"Heidelberg University","startDate":"2009-07","conditions":"Intracranial Hemorrhages","enrollment":54},{"nctId":"NCT02845232","phase":"","title":"Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2013-03","conditions":"Acute Myeloid Leukemia","enrollment":214},{"nctId":"NCT02362178","phase":"PHASE2","title":"Thromboelastographic Guide for Blood Products in Cirrhotics","status":"COMPLETED","sponsor":"University of Modena and Reggio Emilia","startDate":"2011-02","conditions":"Liver Cirrhosis, Coagulation Disorder","enrollment":60},{"nctId":"NCT00233246","phase":"PHASE3","title":"Fresh-Frozen Plasma Infusions to Reduce Risk of Bleeding Related to Invasive Procedures","status":"WITHDRAWN","sponsor":"Massachusetts General Hospital","startDate":"2006-03","conditions":"Blood Coagulation Disorders","enrollment":""},{"nctId":"NCT00799773","phase":"PHASE3","title":"Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)","status":"TERMINATED","sponsor":"Carelon Research","startDate":"2009-04","conditions":"Thrombotic Thrombocytopenic Purpura","enrollment":3},{"nctId":"NCT01143909","phase":"NA","title":"Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients","status":"COMPLETED","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2010-05","conditions":"Blood Coagulation Disorders, Hemorrhage","enrollment":81},{"nctId":"NCT01834092","phase":"NA","title":"Study of the Glycocalyx in Abdominal Aortic Aneurysm","status":"UNKNOWN","sponsor":"Rigshospitalet, Denmark","startDate":"2013-04","conditions":"Abdominal Aortic Aneurism, Surgery, Ischemic Reperfusion Injury","enrollment":50},{"nctId":"NCT01670812","phase":"PHASE3","title":"Trial of FFP+HDMP+Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia","status":"UNKNOWN","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2012-01","conditions":"Chronic Lymphocytic Leukemia","enrollment":100},{"nctId":"NCT00968487","phase":"PHASE1","title":"The Safety of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Healthy Volunteers","status":"COMPLETED","sponsor":"HemCon Medical Technologies, Inc","startDate":"2010-06","conditions":"Healthy","enrollment":16},{"nctId":"NCT00770718","phase":"PHASE1","title":"Factor VII, Prothrombin Complex Concentrate, and Fresh Frozen Plasma in Warfarin-Related Intracranial Hemorrhage","status":"TERMINATED","sponsor":"University of Utah","startDate":"2008-04","conditions":"Intracranial Hemorrhage","enrollment":2},{"nctId":"NCT00892827","phase":"PHASE2","title":"Combined Treatment With Fresh Frozen Plasma and Rituximab (Mabthera) in Patients With Advanced Refractory Chronic Lymphocytic Leukemia","status":"UNKNOWN","sponsor":"Wolfson Medical Center","startDate":"2009-04","conditions":"Advanced Refractory Chronic Lymphocytic Leukemia","enrollment":10}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"ANAEMIA"},{"count":1,"reaction":"CYTOPENIA"},{"count":1,"reaction":"HEADACHE"},{"count":1,"reaction":"LEUKOPENIA"},{"count":1,"reaction":"POLYNEUROPATHY"},{"count":1,"reaction":"RECTAL HAEMORRHAGE"}],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Fresh Frozen Plasma (FFP)","genericName":"Fresh Frozen Plasma (FFP)","companyName":"Vascular Solutions LLC","companyId":"vascular-solutions-llc","modality":"Biologic","firstApprovalDate":"","aiSummary":"Fresh Frozen Plasma replaces deficient clotting factors and other plasma proteins to restore hemostatic function in patients with coagulopathy or massive bleeding. Used for Coagulopathy due to multiple clotting factor deficiencies, Massive transfusion and dilutional coagulopathy, Reversal of warfarin in emergency settings (when prothrombin complex concentrate unavailable).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}