Restarting Anticoagulation After Traumatic Intracranial Hemorrhage
This study is looking for the best time to restart a Direct Oral Anticoagulant (DOAC) medication after a traumatic brain bleed (intracranial hemorrhage). If you've had a brain bleed caused by trauma and were taking a DOAC for conditions like non-valvular atrial fibrillation (a type of irregular heartbeat) or VTE (blood clots in veins), you might be able to join. The study will compare restarting DOACs at 1 week, 2 weeks, or 4 weeks after the bleed. The main goal is to find the timing that leads to the fewest new blood clots (thrombotic events) and major bleeding issues. The study aims to enroll about 1100 participants aged 18 and older.
- Study design
- This is a randomized study where about 1100 participants will be assigned to restart their DOAC at 1, 2, or 4 weeks. It is an open-label study, meaning you and your doctor will know which group you are in, but the people evaluating the results will not.
- What's involved
- Entry into the trial is based on your clinician's decision to restart a DOAC after a traumatic brain bleed. The DOAC will be given at its usual dose, with adjustments made based on your kidney function.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 60 days after their brain bleed event to check for blood clots and bleeding events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Restarting Anticoagulation After Traumatic Intracranial Hemorrhage
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Truman J Milling, MD · PRINCIPAL_INVESTIGATOR · Seton Dell Medical School Stroke Institute
Who to contact
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What this trial measures
- 60 Day Composite of Thrombotic and Bleeding Events60 days following index bleeding event
Composite of Thrombotic events, defined as DVT, PE, MI, Ischemic Strokes, and systemic emboli, cardiovascular death along with bleeding events defined as non-CNS major bleeding, worsening index tICrH, or new intracranial hemorrhage.