Fibrin Sealant Vascular Surgery Study

PHASE2CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

November 30, 2008

Study Completion Date

December 31, 2008

Conditions
Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
Interventions
BIOLOGICAL

FS VH S/D 500 s-apr, 60-seconds polymerization time

FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.

BIOLOGICAL

FS VH S/D 500 s-apr, 120-seconds polymerization time

Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.

PROCEDURE

Manual compression with surgical gauze pads

Treatment of the study suture line with manual compression with surgical gauze pads.

Trial Locations (11)

Unknown

Birmingham

Tucson

Long Beach

Jacksonville

Lexington

Baton Rouge

Pittsburgh

Salt Lake City

Charlottesville

Virginia Beach

Seattle

All Listed Sponsors
lead

Baxter Healthcare Corporation

INDUSTRY

NCT00576420 - Fibrin Sealant Vascular Surgery Study | Biotech Hunter | Biotech Hunter