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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: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT00958581 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 177 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00958581 record still lists
NCT00958581 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 3 interventions - of which Tranexamic Acid is the first listed.
NCT00958581 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00958581's enrollment target sits among peer trials
177 477th of 2000 higher than 1,524 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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