Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

June 30, 2015

Study Completion Date

December 31, 2015

Conditions
Bleeding
Interventions
DRUG

TachoSil®

TachoSil® is a sterile, ready-to-use, absorbable patch for intra-operative topical application. It consists of an equine collagen patch coated with fibrin glue components: human fibrinogen and human thrombin.

DRUG

Surgicel® Original

Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)

Trial Locations (37)

Unknown

Nycomed Investigational Site, Birmingham

Birmingham

Little Rock

Long Beach

Nycomed Investigational Site, Los Angeles

Los Angeles

Loveland

Jacksonville

Nycomed Investigational Site, Austell

Austell

Skokie

Nycomed Investigational Site, Springfield

Springfield

Nycomed Investigational Site, Lexington

Lexington

Worcester

Southfield

St Louis

Hackensack

East Setauket

Flushing

Nycomed Investigational Site, New York

New York

The Bronx

Durham

Raleigh

Winston-Salem

Toledo

Portland

Nycomed Investigational Site, Galveston

Galveston

Nycomed Investigational Site, Houston

Houston

Lubbock

Nycomed Investigational Site, Bellevue

Bellevue

Charleston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Baxter Healthcare Corporation

INDUSTRY

lead

Takeda

INDUSTRY