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NCT00958581 · ClinicalTrials.gov registry record · Phase 4
Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 177
- Enrollment target
NCT00958581 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 177 participants.
The verdict
NCT00958581, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 177 participants
- Enrollment target
Study Summary
Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce blood loss in the cardiac surgery literature but they have not been reported in use head-to-head in the orthopedic surgery literature. In a randomized, double-blind, prospective study we believe that TXA will be more effective than both EACA and placebo at reducing blood loss for corrective spinal surgery.
Interventions
- DRUG Tranexamic Acid
- DRUG Normal Saline
- DRUG Epsilon aminocaproic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2008-12 |
| Est. Completion | 2012-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00958581
The ClinicalTrials.gov registry entry for NCT00958581 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 177 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Tranexamic Acid is the first listed.
NCT00958581 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00958581 about?
NCT00958581 is a clinical study titled "Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery". Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce blood loss in the cardiac surgery literature but they have not been reported in use head-to-head in the orthopedic surgery literature. In a randomized, double-blind, prospective study we believe that TXA will be ...
What is the current status of trial NCT00958581?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 177 participants. The study started on 2008-12. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00958581?
The interventions under investigation include: Tranexamic Acid (DRUG), Normal Saline (DRUG), Epsilon aminocaproic acid (DRUG).
Who is sponsoring clinical trial NCT00958581?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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