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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 is a Phase 2 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 95 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00681824
The ClinicalTrials.gov registry entry for NCT00681824 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxter Healthcare Corporation, which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT00681824 reports 0 study locations.
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.
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