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NCT00681824 · ClinicalTrials.gov registry record · Phase 2
Fibrin Sealant for the Sealing of Dura Sutures
A Phase 2 study, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT00681824: Completed Phase 2 study, sponsored by Baxter Healthcare Corporation.
NCT00681824 is a Phase 2 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00681824, a Phase 2 study, has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an adjunct to dura and dura substitute sutures in preventing postoperative cerebrospinal fluid (CSF) leakage.
Primary Outcome
Study-relevant CSF leakage is defined as one or more of following: 1. Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2-transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI) 2. Epidural CSF collection in surgical area depicted by CT or MRI 3. Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2-transferrin 4. Progressive pneumatocephalus (ai
Interventions
- PROCEDURE Standard of care
- BIOLOGICAL Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00681824 record still lists
NCT00681824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT00681824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00681824 about?
NCT00681824 is a clinical study titled "Fibrin Sealant for the Sealing of Dura Sutures". The purpose of this study is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an adjunct to dura and dura substitute sutures in preventing postoperative cerebrospinal fluid (CSF) l...
What is the current status of trial NCT00681824?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2008-05. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00681824?
The interventions under investigation include: Standard of care (PROCEDURE), Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00681824?
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 NCT00681824's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 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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