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Restarting Anticoagulation After Traumatic Intracranial Hemorrhage

Study acronym: Restart tICrH
StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Minor Secondary endpoints: 2 to 3
    • Study description expanded, about 63 words
    v8
  2. Minor Eligibility criteria expanded, about 9 words
    • Study description expanded, about 9 words
    v7
  3. Minor Eligibility criteria expanded, about 208 words
    • Study description expanded, about 176 words
    v6
  4. Minor Eligibility criteria shortened, about 8 words
    • Study description expanded, about 147 words
    v5
  5. Minor Eligibility criteria expanded, about 10 wordsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Study title shortened, about 3 wordsv3
  2. Notable Primary completion date: Mar 2024 to Dec 2026v2 Show 7 more changesShow less
    • Start date: Mar 2020 to Oct 2021
    • Study sites: 0 to 1
    • Study completion date: Jan 2025 to Feb 2027
    • Secondary endpoints revised (2)
    • Study description expanded, about 159 words
    • Eligibility criteria expanded, about 4 words
    • Study title shortened, about 4 words
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04229758
Lead Sponsor University of Texas at Austin
Conditions
(from sponsor)
Hemorrhage, Intracranial Hemorrhages, Bleeding, Trauma
Related terms Hemorrhage, Intracranial Hemorrhages, Wounds and Injuries
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov