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NCT00576420 · ClinicalTrials.gov registry record · Phase 2
Fibrin Sealant Vascular Surgery Study
A Phase 2 study, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT00576420: Completed Phase 2 study, sponsored by Baxter Healthcare Corporation.
NCT00576420 is a Phase 2 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00576420, a Phase 2 study, has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.
Primary Outcome
Hemostasis at the study suture line must be maintained. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period.
Interventions
- BIOLOGICAL FS VH S/D 500 s-apr, 60-seconds polymerization time
- BIOLOGICAL FS VH S/D 500 s-apr, 120-seconds polymerization time
- PROCEDURE Manual compression with surgical gauze pads
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2007-12 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00576420 record still lists
NCT00576420 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 3 interventions - of which FS VH S/D 500 s-apr, 60-seconds polymerization time is the first listed.
NCT00576420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00576420 about?
NCT00576420 is a clinical study titled "Fibrin Sealant Vascular Surgery Study". The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as c...
What is the current status of trial NCT00576420?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2007-12. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00576420?
The interventions under investigation include: FS VH S/D 500 s-apr, 60-seconds polymerization time (BIOLOGICAL), FS VH S/D 500 s-apr, 120-seconds polymerization time (BIOLOGICAL), Manual compression with surgical gauze pads (PROCEDURE).
Who is sponsoring clinical trial NCT00576420?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00576420's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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