{"id":"factor-concentrate-bebulin","safety":{"commonSideEffects":[{"rate":null,"effect":"Thromboembolism"},{"rate":null,"effect":"Disseminated intravascular coagulation (DIC)"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Bebulin contains lyophilized concentrates of the vitamin K-dependent coagulation factors II, VII, IX, and X derived from human plasma. It is used to rapidly correct coagulopathy and restore clotting capacity in patients with deficiencies of these factors, such as those with warfarin overdose, liver disease, or vitamin K deficiency. The concentrate works by directly supplying the missing clotting factors needed for the intrinsic and common coagulation pathways.","oneSentence":"Bebulin is a prothrombin complex concentrate that replaces deficient vitamin K-dependent clotting factors (II, VII, IX, X) to restore hemostatic function.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:30:19.771Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Warfarin reversal in patients with serious bleeding"},{"name":"Coagulopathy due to vitamin K deficiency"},{"name":"Coagulopathy associated with liver disease"},{"name":"Urgent reversal of anticoagulation"}]},"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 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Policlinico S. Donato","startDate":"2020-02-27","conditions":"Bleeding, Cardiac Defect, Surgery--Complications","enrollment":40},{"nctId":"NCT03320603","phase":"NA","title":"Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants","status":"COMPLETED","sponsor":"Octapharma","startDate":"2017-10-13","conditions":"Emergency Care for Severe Bleeding While on Anticoagulants","enrollment":397},{"nctId":"NCT02319460","phase":"","title":"An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2014-04-24","conditions":"Hemorrhage","enrollment":2238},{"nctId":"NCT01159210","phase":"PHASE4","title":"Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2010-07-09","conditions":"Prothrombin Complex Factor Deficiency","enrollment":61},{"nctId":"NCT01128881","phase":"PHASE4","title":"IMMUNINE Pre-Treatment Study","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2010-05-31","conditions":"Hemophilia B","enrollment":57},{"nctId":"NCT02392156","phase":"","title":"Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes","status":"TERMINATED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2015-07","conditions":"Hemophilia A, Hemophilia B","enrollment":3},{"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":"NCT04114643","phase":"PHASE2","title":"Factor Replacement in Surgery","status":"UNKNOWN","sponsor":"University Health Network, Toronto","startDate":"2019-09-24","conditions":"Bleeding in Cardiac Surgery","enrollment":103},{"nctId":"NCT03981484","phase":"PHASE2","title":"REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy","status":"UNKNOWN","sponsor":"Bellal A. Joseph, MD, FACS","startDate":"2020-01","conditions":"Coagulopathy, Hemorrhage","enrollment":280},{"nctId":"NCT02047565","phase":"PHASE1","title":"A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2013-10","conditions":"Bleeding","enrollment":110},{"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":"NCT01656330","phase":"PHASE1","title":"A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult 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Hemorrhage","enrollment":2},{"nctId":"NCT00168077","phase":"PHASE3","title":"Prothrombin Complex Concentrate for Anticoagulant Reversal","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2005-09","conditions":"Acquired Coagulation Factor Deficiency","enrollment":40},{"nctId":"NCT00004801","phase":"PHASE1, PHASE2","title":"Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency","status":"COMPLETED","sponsor":"National Center for Research Resources (NCRR)","startDate":"1992-03","conditions":"Hemophilia B, Factor IX 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Used for Warfarin reversal in patients with serious bleeding, Coagulopathy due to vitamin K deficiency, Coagulopathy associated with liver disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}