{"id":"fs-vh-s-d-500-s-apr","safety":{"commonSideEffects":[{"rate":null,"effect":"Transfusion-related acute lung injury (TRALI)"},{"rate":null,"effect":"Allergic reaction"},{"rate":null,"effect":"Circulatory overload"},{"rate":null,"effect":"Infection transmission (reduced with S/D treatment)"}]},"_chembl":{"chemblId":"CHEMBL3186011","moleculeType":"Small molecule","molecularWeight":"199.25"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a pathogen-reduced fresh frozen plasma (FFP) prepared using solvent/detergent (S/D) treatment, which inactivates enveloped viruses while preserving coagulation factors and other plasma proteins. It is used as a hemostatic agent to replace deficient clotting factors in patients with coagulopathy or massive transfusion requirements. The S/D treatment process enhances viral safety compared to standard FFP.","oneSentence":"FS VH S/D is a solvent/detergent-treated fresh frozen plasma product that provides multiple clotting factors and plasma proteins for hemostasis support.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:30.181Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Coagulopathy requiring clotting factor replacement"},{"name":"Massive transfusion / hemorrhage management"},{"name":"Deficiency of multiple clotting factors"}]},"trialDetails":[{"nctId":"NCT02891070","phase":"PHASE3","title":"Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery","status":"COMPLETED","sponsor":"Baxter Healthcare Corporation","startDate":"2016-10-11","conditions":"Cerebrospinal Fluid Leak","enrollment":224},{"nctId":"NCT00681824","phase":"PHASE2","title":"Fibrin Sealant for the Sealing of Dura Sutures","status":"COMPLETED","sponsor":"Baxter Healthcare Corporation","startDate":"2008-05","conditions":"Pathological Processes in the Posterior Fossa, Dura Defects","enrollment":95},{"nctId":"NCT01244425","phase":"PHASE2","title":"Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection","status":"COMPLETED","sponsor":"Baxter Healthcare Corporation","startDate":"2010-11","conditions":"Bleeding (Oozing) in Hepatic Resection","enrollment":70},{"nctId":"NCT00892957","phase":"PHASE3","title":"FS VH S/D 500 S-apr in Vascular Surgery","status":"COMPLETED","sponsor":"Baxter Healthcare Corporation","startDate":"2009-07","conditions":"Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses","enrollment":176},{"nctId":"NCT00576420","phase":"PHASE2","title":"Fibrin Sealant Vascular Surgery Study","status":"COMPLETED","sponsor":"Baxter Healthcare Corporation","startDate":"2007-12","conditions":"Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)","enrollment":101}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Tisseel"],"phase":"phase_3","status":"active","brandName":"FS VH S/D 500 s-apr","genericName":"FS VH S/D 500 s-apr","companyName":"Baxter Healthcare Corporation","companyId":"baxter-healthcare-corporation","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FS VH S/D is a solvent/detergent-treated fresh frozen plasma product that provides multiple clotting factors and plasma proteins for hemostasis support. Used for Coagulopathy requiring clotting factor replacement, Massive transfusion / hemorrhage management, Deficiency of multiple clotting factors.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}