NCT00576420

Fibrin Sealant Vascular Surgery Study

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 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.

Conditions

• Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)

Interventions

Type	Name	Description
BIOLOGICAL	FS VH S/D 500 s-apr, 60-seconds polymerization time	FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.
BIOLOGICAL	FS VH S/D 500 s-apr, 120-seconds polymerization time	Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.
PROCEDURE	Manual compression with surgical gauze pads	Treatment of the study suture line with manual compression with surgical gauze pads.

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2007-12-19
• Last updated: 2012-11-27
• Results posted: 2012-11-27

Locations

11 sites across 1 country: United States