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Evaluation of the Topical Hemostatic Efficacy and Safety of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass. If bleeding is still present after conventional surgical methods to achieve hemostasis have been applied FS VH S/D or Tisseel VH are applied. Achievement of hemostasis within 5 minutes is compared between the study groups.
Details
| Lead sponsor | Baxter Healthcare Corporation |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Start date | 2002-09 |
| Completion | 2004-11 |
Conditions
- Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy
- Cardiopulmonary Bypass
- Sternotomy
Interventions
- Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D)
- TISSEEL VH fibrin sealant
Countries
United States