Trial Information

Summary: Men and Women 18 and older who plan to undergo vascular surgery, neede for research study

UVa Health System, Department of Surgery, seeks men and women 18 years of age and older who plan to undergo vascular surgery involving the implant of a dialysis graft or a bypass graft in the leg, for a research study.

The purpose of this study is to test an investigational fibrin sealant (a product used to help stop bleeding in different types of operations) when it is used in certain types of vascular surgery (operations involving the blood vessels). Patients scheduled to have an operation where a material called ePTFE (expanded polytetrafluoroethylene) will be used as a graft (a tube) may be eligible to participate. Sometimes, there is bleeding at the line where the PTFE graft is connected the blood vessel which requires some additional treatments during the operation to control the bleeding. The performance of the fibrin sealant will be compared to direct pressure with gauze pads to see if it can stop bleeding faster at the suture line, where the graft connects to the blood vessel. The study involves several blood draws and an outpatient follow-up visit 2 weeks after the surgery. Patients will also be contacted by phone one month after surgery.

The fibrin sealant and study required blood tests will be provided at no charge
Participants will be expected to pay for the surgery any other procedures that are considered routine care related to their surgery

Contact Information:
For more information please contact:
Zona Chalifoux, RN
Surgical Therapeutic Advancement Center, by phone: 434-243-0315, or by email at uvastac@virginia.edu
IRB-HSR # 13513

Principal Investigator: John Kern, M.D.




www.healthsystem.virginia.edu/clinical_trials

If you would like to learn more about participating in this study, please send an e-mail message using the form below.