Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery

IRB Number

12-425

ClinicalTrials.gov Identifier

NCT01662856

Trial Status

Open for Enrollment
Phase 3

Why is this study being done?

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.

Who is eligible to participate?

Males/Females undergoing Lower Extremity Bypass Grafting or Upper Extremity Dialysis Graft placement using PTFE graft.

What is involved?

Bypass surgery, then clinic visits at 3 days, 7 days, 14 days, 6 weeks, 3 months, and 6 months after surgery.

How long is the study?

You will be in the study approximately 7 months.

Who can I contact for additional information?

You may contact Tiffany Whitaker,RN at 217-545-2320 or email twhitaker@siumed.edu

Who is the Principal Investigator of this study?

Kim Hodgson, MD

Where is the trial located?

Springfield, Illinois