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
Public ClinicalTrials.gov record NCT00161733. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00161733
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2002 (Type not available)
- Primary completion
- Not listed
- Completion
- Nov 2004 (Type not available)
- Last update posted
- Apr 5, 2017
2002 – 2004
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Health Research Institute | Phoenix | Arizona | 85006 | — |
| UCI Medical Center | Orange | California | 92868-3298 | — |
| Shands Hospital at the University of Florida | Gainesville | Florida | 32610-0286 | — |
| Brevard Cardio Surgeons/Health First Heart Institute | Melbourne | Florida | 32901 | — |
| Peachtree Cardiovascular | Atlanta | Georgia | 30342 | — |
| St. Joseph's/Candler Health System, Inc. | Savannah | Georgia | 31405 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536-0293 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215-5501 | — |
| Cardiac Surgery Service, Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109-0344 | — |
| Washington University Medical Center | St Louis | Missouri | 63110 | — |
| UMDNJ - Robert Wood Johnson Medical School | Camden | New Jersey | 08103 | — |
| Lenox Hill Hospital | New York | New York | 10021 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| The Linder Clinical Trial Center | Cincinnati | Ohio | 45219 | — |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The Oregon Clinic | Portland | Oregon | 97213 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Franciscan Health System Research Center | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00161733, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 5, 2017 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00161733 live on ClinicalTrials.gov.