{"id":"protamine-fixed-dose","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypotension"},{"rate":null,"effect":"Bradycardia"},{"rate":null,"effect":"Dyspnea"},{"rate":null,"effect":"Flushing"},{"rate":null,"effect":"Anaphylaxis (rare)"}]},"_chembl":{"chemblId":"CHEMBL1201651","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Protamine sulfate is a cationic polypeptide derived from fish sperm that rapidly binds to negatively charged heparin molecules, forming a stable salt complex that is devoid of anticoagulant activity. This reversal of heparin's anticoagulant effect occurs within minutes of intravenous administration. Protamine is used clinically to counteract heparin overdose or to reverse heparin anticoagulation at the end of cardiac surgery or other procedures.","oneSentence":"Protamine is a positively charged protein that binds to and neutralizes the anticoagulant effects of heparin by forming an inactive complex.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:03:07.670Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Reversal of heparin anticoagulation"},{"name":"Management of heparin overdose"}]},"trialDetails":[{"nctId":"NCT05426031","phase":"PHASE4","title":"Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass","status":"COMPLETED","sponsor":"University of Miami","startDate":"2022-06-28","conditions":"Coagulation; Intravascular","enrollment":130},{"nctId":"NCT05944107","phase":"PHASE4","title":"Anticoagulation Management in Complex Cardiac Surgery","status":"COMPLETED","sponsor":"Aristotle University Of Thessaloniki","startDate":"2021-01-01","conditions":"Extracorporeal Circulation","enrollment":65},{"nctId":"NCT04435912","phase":"EARLY_PHASE1","title":"Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate","status":"COMPLETED","sponsor":"University of Jordan","startDate":"2019-07-04","conditions":"Blood Pressure, Heart Rate, Airway Pressure","enrollment":200},{"nctId":"NCT01068652","phase":"PHASE4","title":"Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2010-03","conditions":"Diabetes, Diabetes Mellitus, Type 2","enrollment":403},{"nctId":"NCT01648218","phase":"PHASE4","title":"Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia","status":"TERMINATED","sponsor":"Vancouver General Hospital","startDate":"2012-08","conditions":"Post-Transplant Glucocorticoid Induced Diabetes","enrollment":5},{"nctId":"NCT01868568","phase":"PHASE1","title":"Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2008-04","conditions":"Diabetes, Diabetes Mellitus, Type 1","enrollment":55},{"nctId":"NCT01267487","phase":"PHASE4","title":"Clinical Trial Comparing Heparin and Protamine Fixed and Titrated Doses in Cardiac Surgery With Cardiopulmonary Bypass","status":"COMPLETED","sponsor":"SANE-Society of Anesthesiology","startDate":"2009-07","conditions":"Cardiac Surgery, Cardiopulmonary Bypass, Anticoagulation","enrollment":240},{"nctId":"NCT00587444","phase":"PHASE3","title":"Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2001-06","conditions":"Postoperative Hemorrhage","enrollment":270}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":13,"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":"Protamine fixed dose","genericName":"Protamine fixed dose","companyName":"University of Miami","companyId":"university-of-miami","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Protamine is a positively charged protein that binds to and neutralizes the anticoagulant effects of heparin by forming an inactive complex. Used for Reversal of heparin anticoagulation, Management of heparin overdose.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}