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NCT01014403 · ClinicalTrials.gov registry record · Phase 1
Delayed Versus Early Enoxaparin Prophylaxis After Traumatic Brain Injury (TBI)
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT01014403: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT01014403 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01014403, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
Brain injured patients are at high risk for forming blood clots in the legs and lungs. For non-brain injured trauma patients, we decrease the chances of these blood clots forming by placing the patients on a low dose of the blood thinner enoxaparin. Starting patients with a brain injury on the blood thinner is problematic, however, as this can theoretically cause the brain injury to worsen. Trauma surgeons wait a variable period of time before starting this blood thinner because waiting too long can result in the formation of these blood clots in the legs and lungs. Previous research has shown that some brain injuries which are of lower severity can have enoxaparin started at 24 hours after injury if the brain injury is stable on a repeated computed tomography (CT) scan of the head. This is a pilot study designed to look at the rates of worsening of brain injury if the low dose blood thinner is started at 24 versus 96 hours post-injury.
Primary Outcome
Worsening of TBI hemorrhage pattern on any scheduled or PRN CT scans after the initiation of treatment
Interventions
- DRUG placebo
- DRUG enoxaparin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
What the finished NCT01014403 record still lists
NCT01014403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01014403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01014403 about?
NCT01014403 is a clinical study titled "Delayed Versus Early Enoxaparin Prophylaxis After Traumatic Brain Injury (TBI)". Brain injured patients are at high risk for forming blood clots in the legs and lungs. For non-brain injured trauma patients, we decrease the chances of these blood clots forming by placing the patients on a low dose of the blood thinner enoxaparin. Starting patients with a brain injury on the blood...
What is the current status of trial NCT01014403?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2009-11. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01014403?
The interventions under investigation include: placebo (DRUG), enoxaparin (DRUG).
Who is sponsoring clinical trial NCT01014403?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01014403's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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