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Fibrin Sealant Vapor-Heated Solvent/Detergent-treated · 2 trials · 4 indications
| Name | Type | Description |
|---|---|---|
| Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) | DRUG | - |
| TISSEEL VH fibrin sealant | DRUG | - |
| Fibrin Sealant Vapor-Heated Solvent/Detergent-treated | DRUG | - |
Inclusion Criteria: All subjects accepted for this study must be: * Informed of the nature of the study and have provided written informed consent * \>= 18 years of age * Scheduled to undergo cardiac surgery requiring CPB and median sternotomy * Able and willing to comply with the procedures requi...
Fibrin Sealant Vapor-Heated Solvent/Detergent-treated is an investigational surgical hemostatic agent studied for use in cardiac surgery requiring cardiopulmonary bypass and median sternotomy, and in hip replacement surgery. It is applied during these procedures to support hemostasis, meaning control of bleeding at the surgical site.
Fibrin Sealant Vapor-Heated Solvent/Detergent-treated is developed by Baxter International Inc., which trades under the ticker BAX. Baxter is the sponsor of the clinical program evaluating this fibrin sealant product.
Fibrin Sealant Vapor-Heated Solvent/Detergent-treated is in Phase 3 clinical development. It is investigational and has not been established as approved for marketing. The Phase 3 program includes completed studies in hip replacement surgery and in cardiac surgery requiring cardiopulmonary bypass and median sternotomy.
Two Phase 3 trials have evaluated Fibrin Sealant Vapor-Heated Solvent/Detergent-treated. NCT00161902 studied hemostasis in subjects undergoing total hip replacement in Austria, Germany, and the Netherlands. NCT00161733 compared its safety and hemostatic efficacy with licensed TISSEEL VH Fibrin Sealant in subjects undergoing cardiac surgery in the United States. Both trials are completed.
The Phase 3 trials of Fibrin Sealant Vapor-Heated Solvent/Detergent-treated were randomized and double blind. NCT00161733 compared the product with currently licensed TISSEEL VH Fibrin Sealant in cardiac surgery, while NCT00161902 evaluated hemostasis in total hip replacement surgery. Both studies are completed.