{"id":"fibrin-sealant-grifols","safety":{"commonSideEffects":[{"rate":null,"effect":"Allergic reaction"},{"rate":null,"effect":"Thromboembolism (rare, with systemic absorption)"},{"rate":null,"effect":"Infection at surgical site"},{"rate":null,"effect":"Hematoma formation"}]},"_chembl":{"chemblId":"CHEMBL2108390","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The product combines human fibrinogen and human thrombin to create a two-component system that, when mixed at the surgical site, polymerizes fibrinogen into fibrin strands, forming a stable clot. This mechanical seal provides hemostasis and can also serve as a tissue adhesive to promote wound healing and reduce postoperative bleeding complications.","oneSentence":"Fibrin Sealant Grifols is a topical hemostatic agent that forms a fibrin clot to seal wounds and control bleeding during surgical procedures.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:46:39.938Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemostasis and tissue sealing during surgical procedures"},{"name":"Reduction of postoperative bleeding in general, cardiac, and vascular surgery"}]},"trialDetails":[{"nctId":"NCT03461406","phase":"PHASE3","title":"A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants","status":"COMPLETED","sponsor":"Instituto Grifols, S.A.","startDate":"2019-01-18","conditions":"Excessive Bleeding During Surgery","enrollment":186},{"nctId":"NCT01662856","phase":"PHASE3","title":"Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery","status":"COMPLETED","sponsor":"Instituto Grifols, S.A.","startDate":"2012-08","conditions":"Vascular Surgical Bleeding","enrollment":225},{"nctId":"NCT01731938","phase":"PHASE3","title":"Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries","status":"COMPLETED","sponsor":"Grifols Biologicals, LLC","startDate":"2012-11","conditions":"Soft Tissue Surgical Bleeding","enrollment":327},{"nctId":"NCT01754480","phase":"PHASE3","title":"Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries","status":"COMPLETED","sponsor":"Instituto Grifols, S.A.","startDate":"2013-03","conditions":"Parenchymous Tissue Surgical Bleeding","enrollment":325},{"nctId":"NCT00684047","phase":"PHASE2, PHASE3","title":"Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis","status":"COMPLETED","sponsor":"Instituto Grifols, S.A.","startDate":"2008-02","conditions":"Target Bleeding Site During Peripheral Vascular Surgery","enrollment":239}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["FS Grifols"],"phase":"phase_3","status":"active","brandName":"Fibrin Sealant Grifols","genericName":"Fibrin Sealant Grifols","companyName":"Instituto Grifols, S.A.","companyId":"instituto-grifols-s-a","modality":"Biologic","firstApprovalDate":"","aiSummary":"Fibrin Sealant Grifols is a topical hemostatic agent that forms a fibrin clot to seal wounds and control bleeding during surgical procedures. Used for Hemostasis and tissue sealing during surgical procedures, Reduction of postoperative bleeding in general, cardiac, and vascular surgery.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}