NCT00892957

FS VH S/D 500 S-apr in Vascular Surgery

Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.

Conditions

• Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses

Interventions

Type	Name	Description
BIOLOGICAL	Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)	The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).
OTHER	Surgical gauze pads	Manual compression with surgical gauze pads

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-10-01
• Completion: 2010-11-01
• First posted: 2009-05-05
• Last updated: 2012-11-27
• Results posted: 2012-11-27

Locations

22 sites across 1 country: United States