SIU School of Medicine

Jump directly to a section:

A Randomized, Open Label, Parallel Group, Multi-center Trial to Compare Efficacy and Safety of TachoSil Versus Surgicel Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery

IRB Number

12-136

ClinicalTrials.gov Identifier

NCT01500135

Trial Status

Open for Enrollment
Phase 3

Why is this study being done?

Present trial is one of two trials (the other being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and efficacy data to support a general hemostasis indication across several surgical procedures and organ systems in the USA. The patient will come for a screening and baseline visit, the day of surgery and follow up visits after 1 months, 3 months and 6 months. The enrollment period is planned for 16 months and 6 months of follow up.

Who is eligible to participate?

Patients undergoing prosthetic lower extremity bypass

What is involved?

Patients who experience bleeding at the most proximal graft site will be treated with either the Study Drug, TachoSil, or a commercially available fibrin sealant, Surgicel Original to treat the bleeding.

How long is the study?

Patients will be in the study for six months.

Who can I contact for additional information?

Tiffany Whitaker, RN (217) 545-2531 twhitaker@siumed.edu

Who is the Principal Investigator of this study?

Kim Hodgson, MD

Where is the trial located?

Springfield, Illinois