The purpose of this study is to obtain data to support the approval of a new human plasma-derived fibrin sealant (FS Grifols), manufactured by Instituto Grifols, S.A., Barcelona, Spain, by demonstrating that FS Grifols is both safe and effective in stopping bleeding during peripheral vascular surgery.
Males/Females undergoing Lower Extremity Bypass Grafting or Upper Extremity Dialysis Graft placement using PTFE graft.
Bypass surgery, then clinic visits at 3 days, 7 days, 14 days, 6 weeks, 3 months, and 6 months after surgery.
You will be in the study approximately 7 months.
You may contact Tiffany Whitaker,RN at 217-545-2320 or email firstname.lastname@example.org
Kim Hodgson, MD