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NCT00161733 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Cardiopulmonary Bypass and Sternotomy, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Study locations
NCT00161733: Completed Phase 3 study of Cardiopulmonary Bypass and Sternotomy, sponsored by Baxter Healthcare Corporation.
NCT00161733 is a Phase 3 study of Cardiopulmonary Bypass and Sternotomy that has completed, run by Baxter Healthcare Corporation. The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00161733, a Phase 3 study of Cardiopulmonary Bypass and Sternotomy, has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Start Date | 2002-09 |
| Est. Completion | 2004-11 |
| Phase | Phase 3 |
What the finished NCT00161733 record still lists
NCT00161733 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
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.
NCT00161733 names 20 study sites across 16 states, led by Florida, Georgia, Massachusetts.
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.
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).
Who is sponsoring clinical trial NCT00161733?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
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.
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