Restarting Anticoagulation After Traumatic Intracranial Hemorrhage
Status:
Not yet recruiting
Trial end date:
2027-02-01
Target enrollment:
Participant gender:
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