{"id":"fibrinogen-pcc","safety":{"commonSideEffects":[{"rate":null,"effect":"Thromboembolism (venous thromboembolism, stroke)"},{"rate":null,"effect":"Allergic reaction"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Disseminated intravascular coagulation (paradoxical worsening)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fibrinogen provides the structural protein substrate for clot formation, while prothrombin complex concentrate (PCC) supplies vitamin K-dependent clotting factors (II, VII, IX, X) to restore the extrinsic and common coagulation pathways. Together, they address both fibrinogen deficiency and factor deficiencies that occur in massive transfusion, disseminated intravascular coagulation, or warfarin reversal scenarios.","oneSentence":"This combination replaces depleted fibrinogen and restores multiple clotting factors simultaneously to correct severe coagulopathy and promote hemostasis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:32:50.662Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Massive hemorrhage with coagulopathy requiring fibrinogen and factor replacement"},{"name":"Disseminated intravascular coagulation (DIC)"},{"name":"Warfarin reversal in life-threatening bleeding"}]},"trialDetails":[{"nctId":"NCT06144112","phase":"PHASE4","title":"Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery","status":"NOT_YET_RECRUITING","sponsor":"Konkuk University Medical Center","startDate":"2025-09-01","conditions":"Liver Diseases","enrollment":92},{"nctId":"NCT07043556","phase":"","title":"Assessment of Artificial Intelligence Algorithms for ROTEM","status":"RECRUITING","sponsor":"Ondokuz Mayıs University","startDate":"2025-07-01","conditions":"Coagulopathy","enrollment":144},{"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},{"nctId":"NCT06153082","phase":"NA","title":"Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Non-variceal Bleeding.","status":"RECRUITING","sponsor":"Institute of Liver and Biliary Sciences, India","startDate":"2023-12-16","conditions":"Liver Cirrhosis","enrollment":80},{"nctId":"NCT04534751","phase":"PHASE4","title":"Factor In the Initial Resuscitation of Severe Trauma 2 Patients","status":"UNKNOWN","sponsor":"University Health Network, Toronto","startDate":"2021-04-01","conditions":"Traumatic Hemorrhage, Coagulopathy, Massive Hemorrhage","enrollment":350},{"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":"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":"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":"NCT02461251","phase":"NA","title":"Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients","status":"COMPLETED","sponsor":"Tampere University Hospital","startDate":"2016-01","conditions":"Obstetric Labor Complications, Hemorrhage","enrollment":59},{"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":"NCT02416817","phase":"PHASE4","title":"Strategy of Transfusion in Trauma Patients - STATA Trial","status":"COMPLETED","sponsor":"University of Sao Paulo General Hospital","startDate":"2014-07","conditions":"Wounds and Injuries","enrollment":156},{"nctId":"NCT01545635","phase":"PHASE3","title":"RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma","status":"TERMINATED","sponsor":"Medical University Innsbruck","startDate":"2012-03","conditions":"Major Trauma","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Fibryga + Octaplex"],"phase":"marketed","status":"active","brandName":"Fibrinogen + PCC","genericName":"Fibrinogen + PCC","companyName":"University Health Network, Toronto","companyId":"university-health-network-toronto","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combination replaces depleted fibrinogen and restores multiple clotting factors simultaneously to correct severe coagulopathy and promote hemostasis. Used for Massive hemorrhage with coagulopathy requiring fibrinogen and factor replacement, Disseminated intravascular coagulation (DIC), Warfarin reversal in life-threatening bleeding.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}