A Prospective, Randomized Controlled Study to Compare the Effects of a Fibrin Sealant (FS2) Versus Manual Compression on Haemostatic Efficacy During Vascular Surgical Procedures Utilising Polytetrafluorethylene Graft Material on an End-to-Side Femoral or Upper Extremity Vascular Access Arterial Anastomosis

Ethicon, Inc.17 sites in 2 countries150 target enrollmentJune 2005

Overview

A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

March 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio.
•Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS.
•Subjects must be willing to and capable of participating in the study, and provided written informed consent.

•Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE.
•Subjects undergoing emergency surgery.
•Subjects with any intra-operative findings that may preclude conduct of the study procedure.
•Subjects with known intolerance to heparin, blood products or to one of the components of the study product.
•Subjects unwilling to receive blood products.
•Subjects with autoimmune immunodeficiency diseases (including known HIV).
•Subjects who are known, current alcohol and / or drug abusers.
•Subjects who have participated in another investigational drug or device research study within 30 days of enrolment.
•Female subjects who are pregnant or nursing.