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

NCT ID: NCT00161733

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2004-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

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

Intervention Type: DRUG

TISSEEL VH fibrin sealant

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

All subjects accepted for this study must be:

• Informed of the nature of the study and have provided written informed consent
• >= 18 years of age
• Scheduled to undergo cardiac surgery requiring CPB and median sternotomy
• Able and willing to comply with the procedures required by the protocol.

Additional Intraoperative Eligibility Criteria (in addition to the above):

Subjects must satisfy the following intraoperative criteria in order to be eligible for treatment with either investigational product:

• Subjects must complete all screening/preoperative evaluations (see study protocol)
• Subjects must present, after cessation of cardiopulmonary bypass and heparin reversal by protamine sulfate, with a minimum of one intraoperative bleeding site which cannot be controlled by conventional surgical techniques (i.e., suture, ligature, cautery, clips, and clamps) alone and which has not been previously treated with any topical hemostatic agent
• Subjects must not have received any commercial or blood bank-derived fibrin sealant prior to application of investigational product.

Exclusion Criteria

Any one or more of the following are cause for exclusion from the study:

• Subject is scheduled to undergo a cardiac surgical procedure which does not require CPB and median sternotomy (e.g., thoracotomy, minimally invasive direct coronary artery bypass, etc.)
• Subject has undergone a sternotomy within 36 hours prior to being randomized under this protocol
• History of any hereditary or acquired bleeding disorders. Subjects concurrently treated with prophylactic antithrombotic therapy (i.e., aspirin, heparin, Warfarin, etc.) are eligible
• Either of the following: International Normalized Ratio (INR) >1.35, activated or partial thromboplastin time (aPTT) greater than 35 seconds in subjects who are not on antithrombotic therapy (i.e., aspirin, heparin, Warfarin, etc.)
• Fibrinogen level less than 150mg/dL
• Platelet count less than 100,000/mm3
• Active hepatic disease (persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 2.5X the upper limit of normal)
• Subject was previously randomized under this protocol
• Pregnancy or lactation
• Known sensitivity to aprotinin or bovine protein
• Subject is currently participating in another clinical study and has received an investigational product or device within 30 days prior to study entry
• Treatment with thrombolytic agents (e.g. tissue plasminogen activator [tPA], Streptase® [streptokinase], Activase® [alteplase], Retavase® [reteplase],) Integrilin® (eptifibatide), Aggrastat® (tirofiban), Plavix® (clopidogrel), ReoPro® (abciximab), or Ticlid® (ticlopidine), Pletal® (cilostazol) < 24 hours prior to treatment with investigative product
• Subject is scheduled for heart transplantation
• Subject is scheduled for left ventricular assist device insertion or removal
• Subject is scheduled to undergo any surgical procedure other than the cardiac surgery for which the subject is being treated under this protocol within 14 days prior to treatment. Surgeries in the pericardium associated with the cardiac surgery and not specifically excluded above are permitted.
• Subject has an anticipated life expectancy of <=6 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jeffrey Milliken, MD

Role: PRINCIPAL_INVESTIGATOR

UCI Medical Center, Orange, CA

John Rousou, MD

Role: PRINCIPAL_INVESTIGATOR

Baystate Medical Center, Springfield, MA

Charles Klodell, MD

Role: PRINCIPAL_INVESTIGATOR

Shads Hospital at the University of Florida, Gainesville, FL

Russell Vester, MD

Role: PRINCIPAL_INVESTIGATOR

The Linder Clinical Trial Center, Cincinnati, OH

Nicholas Smedira, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic, Cleveland, OH

Steven Bolling, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital, Ann Arbor, MI

Sidney Levitsky, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center, Boston MA

James Lowe, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Durham, NC

E. Charles Douville, MD

Role: PRINCIPAL_INVESTIGATOR

The Oregon Clinic, Portland, OR

Robert Jones, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph´s/Candler Health System, Inc., Savannah, GA

Robert Mentzer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky Medical Center, Lexington, KY

Steven Macheers, MD

Role: PRINCIPAL_INVESTIGATOR

Peachtree Cardiovascular, Atlanta, GA

Robert Hebeler, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor University Medical Center, Dallas, TX

Michael Greene, MD

Role: PRINCIPAL_INVESTIGATOR

Brevard Cardio Surgeons/Health First Heart Institute, Melbourne, FL

Valluvan Jeevanandam, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Medical Center, Chicago, IL

John Luber, MD

Role: PRINCIPAL_INVESTIGATOR

Franciscan Health System Research Center, Tacoma, WA

Irving Kron, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vigrinia Health System, Charlottesville, VA

Michael McGrath, MD

Role: PRINCIPAL_INVESTIGATOR

Sentara Norfolk General Hospital, Norfolk, VA

Marc Moon, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University Medical Center, St. Louis, MO

Steven Marra, MD

Role: PRINCIPAL_INVESTIGATOR

UMDNJ - Robert Wood Johnson Medical School, Camden, NJ

Ramachandra Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Lenox Hill Hospital, New York, NY

Pierre Tibi, MD

Role: PRINCIPAL_INVESTIGATOR

Banner health Research Institute, Phoenix, AZ

Locations

Banner Health Research Institute

Phoenix, Arizona, United States

UCI Medical Center

Orange, California, United States

Shands Hospital at the University of Florida

Gainesville, Florida, United States

Brevard Cardio Surgeons/Health First Heart Institute

Melbourne, Florida, United States

Peachtree Cardiovascular

Atlanta, Georgia, United States

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

Savannah, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Cardiac Surgery Service, Baystate Medical Center

Springfield, Massachusetts, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Washington University Medical Center

St Louis, Missouri, United States

UMDNJ - Robert Wood Johnson Medical School

Camden, New Jersey, United States

Lenox Hill Hospital

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

The Linder Clinical Trial Center

Cincinnati, Ohio, United States

The Cleveland Clinic

Cleveland, Ohio, United States

The Oregon Clinic

Portland, Oregon, United States

Baylor University Medical Center

Dallas, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Franciscan Health System Research Center

Tacoma, Washington, United States

Countries

United States

Other Identifiers

550003

Identifier Type: -

Identifier Source: org_study_id