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

Summary

The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass. If bleeding is still present after conventional surgical methods to achieve hemostasis have been applied FS VH S/D or Tisseel VH are applied. Achievement of hemostasis within 5 minutes is compared between the study groups.

Conditions

• Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy
• Cardiopulmonary Bypass
• Sternotomy

Interventions

DRUG

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

DRUG

TISSEEL VH fibrin sealant

Sponsors & Collaborators

• Baxter Healthcare Corporation

  lead INDUSTRY

Principal Investigators

• Jeffrey Milliken, MD · UCI Medical Center, Orange, CA

• John Rousou, MD · Baystate Medical Center, Springfield, MA

• Charles Klodell, MD · Shads Hospital at the University of Florida, Gainesville, FL

• Russell Vester, MD · The Linder Clinical Trial Center, Cincinnati, OH

• Nicholas Smedira, MD · The Cleveland Clinic, Cleveland, OH

• Steven Bolling, MD · University of Michigan Hospital, Ann Arbor, MI

• Sidney Levitsky, MD · Beth Israel Deaconess Medical Center, Boston MA

• James Lowe, MD · Duke University Medical Center, Durham, NC

• E. Charles Douville, MD · The Oregon Clinic, Portland, OR

• Robert Jones, MD · St. Joseph´s/Candler Health System, Inc., Savannah, GA

• Robert Mentzer, MD · University of Kentucky Medical Center, Lexington, KY

• Steven Macheers, MD · Peachtree Cardiovascular, Atlanta, GA

• Robert Hebeler, MD · Baylor University Medical Center, Dallas, TX

• Michael Greene, MD · Brevard Cardio Surgeons/Health First Heart Institute, Melbourne, FL

• Valluvan Jeevanandam, MD · University of Chicago Medical Center, Chicago, IL

• John Luber, MD · Franciscan Health System Research Center, Tacoma, WA

• Irving Kron, MD · University of Vigrinia Health System, Charlottesville, VA

• Michael McGrath, MD · Sentara Norfolk General Hospital, Norfolk, VA

• Marc Moon, MD · Washington University Medical Center, St. Louis, MO

• Steven Marra, MD · UMDNJ - Robert Wood Johnson Medical School, Camden, NJ

• Ramachandra Reddy, MD · Lenox Hill Hospital, New York, NY

• Pierre Tibi, MD · Banner health Research Institute, Phoenix, AZ

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-09-30

Completion

2004-11-30

Countries

• United States

Study Locations