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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy
• Cardiopulmonary Bypass
• Sternotomy

Interventions

Type	Name	Description
DRUG	Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D)
DRUG	TISSEEL VH fibrin sealant

Timeline

• Start date: 2002-09-01
• Completion: 2004-11-01
• First posted: 2005-09-13
• Last updated: 2017-04-05

Locations

22 sites across 1 country: United States