Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery

PHASE3CompletedINTERVENTIONAL
Timeline

Start Date

September 30, 2002

Study Completion Date

November 30, 2004

Conditions
Cardiac Surgery Requiring Cardiopulmonary Bypass and Median SternotomyCardiopulmonary BypassSternotomy
Interventions
DRUG

Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D)

DRUG

TISSEEL VH fibrin sealant

Trial Locations (22)

10021

Lenox Hill Hospital, New York

22908

University of Virginia Health System, Charlottesville

23507

Sentara Norfolk General Hospital, Norfolk

27710

Duke University Medical Center, Durham

30342

Peachtree Cardiovascular, Atlanta

31405

St. Joseph's/Candler Health System, Inc., Savannah

32901

Brevard Cardio Surgeons/Health First Heart Institute, Melbourne

44195

The Cleveland Clinic, Cleveland

45219

The Linder Clinical Trial Center, Cincinnati

60637

University of Chicago Medical Center, Chicago

63110

Washington University Medical Center, St Louis

75246

Baylor University Medical Center, Dallas

85006

Banner Health Research Institute, Phoenix

97213

The Oregon Clinic, Portland

98405

Franciscan Health System Research Center, Tacoma

92868-3298

UCI Medical Center, Orange

32610-0286

Shands Hospital at the University of Florida, Gainesville

40536-0293

University of Kentucky Medical Center, Lexington

02215-5501

Beth Israel Deaconess Medical Center, Boston

01199

Cardiac Surgery Service, Baystate Medical Center, Springfield

48109-0344

University of Michigan Hospital, Ann Arbor

08103

UMDNJ - Robert Wood Johnson Medical School, Camden

All Listed Sponsors
lead

Baxter Healthcare Corporation

INDUSTRY

NCT00161733 - Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery | Biotech Hunter | Biotech Hunter