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COMPLETED Phase 3

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 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D)
  • DRUG TISSEEL VH fibrin sealant

Study Locations (20)

Florida

  • Shands Hospital at the University of Florida — Gainesville
  • Brevard Cardio Surgeons/Health First Heart Institute — Melbourne

Georgia

  • Peachtree Cardiovascular — Atlanta
  • St. Joseph's/Candler Health System, Inc. — Savannah

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston
  • Cardiac Surgery Service, Baystate Medical Center — Springfield

Ohio

  • The Linder Clinical Trial Center — Cincinnati
  • The Cleveland Clinic — Cleveland

Arizona

  • Banner Health Research Institute — Phoenix

California

  • UCI Medical Center — Orange

Illinois

  • University of Chicago Medical Center — Chicago

Kentucky

  • University of Kentucky Medical Center — Lexington

Trial Details

FieldValue
Start Date 2002-09
Est. Completion 2004-11
Phase Phase 3

Sponsor

Baxter Healthcare Corporation

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00161733

The ClinicalTrials.gov registry entry for NCT00161733 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Baxter Healthcare Corporation, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Cardiopulmonary Bypass appearing as the primary indexed condition, and to 2 interventions — of which Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00161733 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, Georgia, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00161733 about?

NCT00161733 is a clinical study titled "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". 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...

What is the current status of trial NCT00161733?

This trial is currently completed. It is a Phase 3 study. The study started on 2002-09. Estimated completion is 2004-11.

What conditions does trial NCT00161733 study?

This clinical trial studies the following conditions: Cardiopulmonary Bypass, Sternotomy, Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00161733?

The interventions under investigation include: Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) (DRUG), TISSEEL VH fibrin sealant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00161733?

This trial is sponsored by Baxter Healthcare Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00161733 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial