{"id":"apcc-apcc-txa","safety":{"commonSideEffects":[{"rate":null,"effect":"Thromboembolism (venous thromboembolism, myocardial infarction)"},{"rate":null,"effect":"Disseminated intravascular coagulation (DIC)"},{"rate":null,"effect":"Allergic reactions"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"aPCC contains activated forms of factors II, VII, IX, and X that bypass deficient or inhibited factors in the coagulation cascade, restoring thrombin generation. The addition of tranexamic acid, a plasminogen inhibitor, prevents excessive fibrin breakdown and stabilizes clots, creating a synergistic hemostatic effect. This combination is used to manage life-threatening bleeding in patients with factor deficiencies or anticoagulant reversal needs.","oneSentence":"aPCC (activated prothrombin complex concentrate) restores coagulation by providing vitamin K-dependent clotting factors, and when combined with TXA (tranexamic acid), is further enhanced by inhibiting fibrinolysis to reduce bleeding.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:17:36.894Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Life-threatening bleeding in patients with factor deficiencies or warfarin/anticoagulant reversal"},{"name":"Perioperative hemostasis management in high-risk bleeding scenarios"}]},"trialDetails":[{"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},{"nctId":"NCT01800435","phase":"PHASE4","title":"A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor","status":"COMPLETED","sponsor":"Oslo University Hospital","startDate":"2011-10","conditions":"Hereditary Factor VIII Deficiency Disease With Inhibitor","enrollment":6}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":11,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Feiba i.v","Feiba i.v + Cyklokapron"],"phase":"marketed","status":"active","brandName":"aPCC, aPCC + TXA","genericName":"aPCC, aPCC + TXA","companyName":"Oslo University Hospital","companyId":"oslo-university-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"aPCC (activated prothrombin complex concentrate) restores coagulation by providing vitamin K-dependent clotting factors, and when combined with TXA (tranexamic acid), is further enhanced by inhibiting fibrinolysis to reduce bleeding. Used for Life-threatening bleeding in patients with factor deficiencies or warfarin/anticoagulant reversal, Perioperative hemostasis management in high-risk bleeding scenarios.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}