{"id":"fs-vh-s-d-4-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":"Febrile non-hemolytic transfusion reaction"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a pathogen-reduced fresh frozen plasma (FFP) product manufactured by Baxter using solvent/detergent (S/D) treatment technology. The S/D process inactivates enveloped viruses (such as HIV, hepatitis C, and hepatitis B) by disrupting their lipid membranes, while preserving the coagulation factors and other plasma proteins needed for hemostasis. It is intended for transfusion in patients with coagulation factor deficiencies.","oneSentence":"FS VH S/D 4 s-apr is a solvent/detergent-treated fresh frozen plasma product designed to provide clotting factors and other plasma proteins while reducing the risk of viral transmission.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:30.149Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Coagulation factor deficiency requiring plasma transfusion"},{"name":"Reversal of warfarin or other vitamin K antagonists"},{"name":"Massive transfusion protocols"}]},"trialDetails":[{"nctId":"NCT01112735","phase":"PHASE2","title":"Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty","status":"COMPLETED","sponsor":"Baxter Healthcare Corporation","startDate":"2010-05","conditions":"Seroma, Hematoma","enrollment":40},{"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},{"nctId":"NCT00999141","phase":"PHASE3","title":"Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy","status":"COMPLETED","sponsor":"Baxter Healthcare Corporation","startDate":"2009-09","conditions":"Face-lift, Facial Rhytidectomy","enrollment":75},{"nctId":"NCT01320514","phase":"","title":"Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift","status":"UNKNOWN","sponsor":"Nguyen, Davis B., M.D.","startDate":"2010-12","conditions":"Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant","enrollment":10}],"_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":["ARTISS"],"phase":"phase_3","status":"active","brandName":"FS VH S/D 4 s-apr","genericName":"FS VH S/D 4 s-apr","companyName":"Baxter Healthcare Corporation","companyId":"baxter-healthcare-corporation","modality":"Biologic","firstApprovalDate":"","aiSummary":"FS VH S/D 4 s-apr is a solvent/detergent-treated fresh frozen plasma product designed to provide clotting factors and other plasma proteins while reducing the risk of viral transmission. Used for Coagulation factor deficiency requiring plasma transfusion, Reversal of warfarin or other vitamin K antagonists, Massive transfusion protocols.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}