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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161733 |
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.
Condition | Intervention | Phase |
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Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy |
Drug: Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) Drug: TISSEEL VH fibrin sealant |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Topical Hemostatic Efficacy and Safety of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
All subjects accepted for this study must be:
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:
Exclusion Criteria:
Any one or more of the following are cause for exclusion from the study:
Principal Investigator: | 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 |
Study ID Numbers: | 550003 |
Study First Received: | September 8, 2005 |
Last Updated: | October 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00161733 |
Health Authority: | United States: Food and Drug Administration |
Cardiopulmonary bypass Median sternotomy Fibrin sealant Clot Cardiac surgery |
Fibrin Tissue Adhesive |
Coagulants Therapeutic Uses Hematologic Agents Pharmacologic Actions Hemostatics |