findmyKOL
Clinical trialNCT00161733CompletedPhase 3Interventional

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

SponsorBaxter Healthcare CorporationCardiac Surgery Requiring Cardiopulmonary Bypass and Median SternotomyCardiopulmonary BypassSternotomy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

22 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Fibrin Sealant Vapor Heated Solvent/Detergent TreatedTISSEEL VH fibrin sealant
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2002
Primary completion
—
Completion
30 Nov 2004
Last update posted
5 Apr 2017
Registered enrollment
—
Registry id
NCT00161733

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.