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

NCT00161733 | Completed Phase 3

• 1 other identifier: 550003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 22

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

Keywords

Cardiopulmonary bypass; Median sternotomy; Fibrin sealant; Clot; Cardiac surgery

Interventions

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

TISSEEL VH fibrin sealant DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (22)

Banner Health Research Institute

Phoenix, Arizona, 85006, United States

Location

UCI Medical Center

Orange, California, 92868-3298, United States

Location

Shands Hospital at the University of Florida

Gainesville, Florida, 32610-0286, United States

Location

Brevard Cardio Surgeons/Health First Heart Institute

Melbourne, Florida, 32901, United States

Location

Peachtree Cardiovascular

Atlanta, Georgia, 30342, United States

Location

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

Savannah, Georgia, 31405, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536-0293, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215-5501, United States

Location

Cardiac Surgery Service, Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109-0344, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

UMDNJ - Robert Wood Johnson Medical School

Camden, New Jersey, 08103, United States

Location

Lenox Hill Hospital

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Linder Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Oregon Clinic

Portland, Oregon, 97213, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Franciscan Health System Research Center

Tacoma, Washington, 98405, United States

Location

Study Officials

• Jeffrey Milliken, MD

  UCI Medical Center, Orange, CA

  PRINCIPAL INVESTIGATOR

• John Rousou, MD

  Baystate Medical Center, Springfield, MA

  PRINCIPAL INVESTIGATOR

• Charles Klodell, MD

  Shads Hospital at the University of Florida, Gainesville, FL

  PRINCIPAL INVESTIGATOR

• Russell Vester, MD

  The Linder Clinical Trial Center, Cincinnati, OH

  PRINCIPAL INVESTIGATOR

• Nicholas Smedira, MD

  The Cleveland Clinic, Cleveland, OH

  PRINCIPAL INVESTIGATOR

• Steven Bolling, MD

  University of Michigan Hospital, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

• Sidney Levitsky, MD

  Beth Israel Deaconess Medical Center, Boston MA

  PRINCIPAL INVESTIGATOR

• James Lowe, MD

  Duke University Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

• E. Charles Douville, MD

  The Oregon Clinic, Portland, OR

  PRINCIPAL INVESTIGATOR

• Robert Jones, MD

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

  PRINCIPAL INVESTIGATOR

• Robert Mentzer, MD

  University of Kentucky Medical Center, Lexington, KY

  PRINCIPAL INVESTIGATOR

• Steven Macheers, MD

  Peachtree Cardiovascular, Atlanta, GA

  PRINCIPAL INVESTIGATOR

• Robert Hebeler, MD

  Baylor University Medical Center, Dallas, TX

  PRINCIPAL INVESTIGATOR

• Michael Greene, MD

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

  PRINCIPAL INVESTIGATOR

• Valluvan Jeevanandam, MD

  University of Chicago Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

• John Luber, MD

  Franciscan Health System Research Center, Tacoma, WA

  PRINCIPAL INVESTIGATOR

• Irving Kron, MD

  University of Vigrinia Health System, Charlottesville, VA

  PRINCIPAL INVESTIGATOR

• Michael McGrath, MD

  Sentara Norfolk General Hospital, Norfolk, VA

  PRINCIPAL INVESTIGATOR

• Marc Moon, MD

  Washington University Medical Center, St. Louis, MO

  PRINCIPAL INVESTIGATOR

• Steven Marra, MD

  UMDNJ - Robert Wood Johnson Medical School, Camden, NJ

  PRINCIPAL INVESTIGATOR

• Ramachandra Reddy, MD

  Lenox Hill Hospital, New York, NY

  PRINCIPAL INVESTIGATOR

• Pierre Tibi, MD

  Banner health Research Institute, Phoenix, AZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: September 1, 2002
• Study Completion: November 1, 2004
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

US (22)