Fibrin Sealant Vascular Surgery Study

Phase 2 Completed 101 enrolled Baxter Healthcare Corporation

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2007-12
Primary completion: 2008-11
Completion: 2008-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); FS VH S/D 500 S-apr - 60-Seconds vs FS VH S/D 500 S-apr - 120-Seconds vs Control Group; p = 0.1564 NCT00576420 ↗

Publications

Results Saha SP, Muluk S, Schenk W 3rd, Burks SG, Grigorian A, Ploder B, Presch I, Pavlova BG, Hantak E. Use of fibrin sealant as a hemostatic agent in expanded polytetrafluoroethylene graft placement surgery. Ann Vasc Surg. 2011 Aug;25(6):813-22. doi: 10.1016/j.avsg.2010.12.016. Epub 2011 Apr 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FS VH S/D 500 s-apr	Protein / enzyme biologic	4 ml	—

Indications

No indication recorded.