drugset / Trial / NCT00161733
Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2002-09
- Primary completion
- —
- Completion
- 2004-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FS VH S/D | Protein / enzyme biologic | — | Topical |
| Subject | TISSEEL VH fibrin sealant | Protein / enzyme biologic | — | Topical |
Indications
No indication recorded.