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NCT04229758 · ClinicalTrials.gov registry record · Phase 3
Restarting Anticoagulation After Traumatic Intracranial Hemorrhage
A Phase 3 study, sponsored by University of Texas at Austin.
- Not yet
- Registry status
- Phase 3
- Development phase
- 1,100
- Enrollment target
NCT04229758 is a Phase 3 study that has not yet begun recruiting, run by University of Texas at Austin. The registered enrollment target is 1,100 participants.
The verdict
NCT04229758, a Phase 3 study, has not yet begun recruiting, sponsored by University of Texas at Austin.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,100 participants
- Enrollment target
Study Summary
Primary Objective: To identify the optimal interval to restart oral anticoagulation after traumatic intracranial hemorrhage that will minimize thrombotic events and major bleeding by performing a response adaptive randomized (RAR) PROBE clinical trial of restarting in anticoagulant-associated traumatic intracranial hemorrhage patients, comparing restart at 1 week to restart at 2 weeks or at 4 weeks, with a primary composite outcome of major thrombotic events and bleeding. Primary Outcome: 60-day composite of thromboembolic events, defined as DVT, pulmonary emboli, myocardial infarctions, ischemic strokes and systemic emboli, and bleeding events defined as non-CNS major bleeding events (modified BARC3 or above) and worsening index tICrH or new intracranial hemorrhage (ICrH). Secondary objectives of this trial include: 1. To use the Trauma Quality Improvement Program (TQIP) of the American College of Surgeons - Committee on Trauma (ACS-COT), a well-established and highly respected trauma center oversight mechanism, to translate findings of the trial into practice in a closed loop. 2. To establish a relationship between time of restarting and overall secondary events, i.e. a dose response, that favors early restarting (1 week is better than 2 weeks and 2 weeks is better than 4 weeks. 3. To explore patient centered utility weighting of thrombotic versus bleeding composite endpoint components by: A) 60-day Disability Rating Scale (DRS) 24,25 and modified Rankin Scale (mRS)26; B) Trial patient-reported standard gamble utilities including by race, gender and ethnicity. 4. To explore the composite without DVT in the thrombotic component
Interventions
- DRUG Anticoagulants
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,100 participants |
| Start Date | 2021-10 |
| Est. Completion | 2027-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04229758
The ClinicalTrials.gov registry entry for NCT04229758 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 1,100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Anticoagulants is the first listed.
NCT04229758 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04229758 about?
NCT04229758 is a clinical study titled "Restarting Anticoagulation After Traumatic Intracranial Hemorrhage". Primary Objective: To identify the optimal interval to restart oral anticoagulation after traumatic intracranial hemorrhage that will minimize thrombotic events and major bleeding by performing a response adaptive randomized (RAR) PROBE clinical trial of restarting in anticoagulant-associated traum...
What is the current status of trial NCT04229758?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 1,100 participants. The study started on 2021-10. Estimated completion is 2027-02.
What interventions are being tested in trial NCT04229758?
The interventions under investigation include: Anticoagulants (DRUG).
Who is sponsoring clinical trial NCT04229758?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
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