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

Phase 3 Completed 176 enrolled Baxter Healthcare Corporation

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2009-07
Primary completion: 2010-10
Completion: 2010-11

Outcome

Met primary endpoint

registry p <0.0001; Likelihood ratio chi-square test NCT00892957 ↗

Publications

Background Saha SP, Muluk S, Schenk W 3rd, Dennis JW, Ploder B, Grigorian A, Presch I, Goppelt A. A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts. J Vasc Surg. 2012 Jul;56(1):134-41. doi: 10.1016/j.jvs.2012.01.009. Epub 2012 May 25.

Drugs

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

Indications

No indication recorded.