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.

NCT04229758

Restarting Anticoagulation After Traumatic Intracranial Hemorrhage

Not Yet Recruiting
PHASE3Ages 18+InterventionalPrevention
University of Texas at Austin
~1,100 participants
Updated 2021-05-19 on ClinicalTrials.gov
What's tested:Anticoagulants

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
60 Day Composite of Thrombotic and Bleeding Events
Measured over 60 days following index bleeding event
Hemorrhage
Intracranial Hemorrhages
Bleeding
Trauma
1 sites across 1 states
Texas1
  • Truman J Milling, MD · PRINCIPAL_INVESTIGATOR · Seton Dell Medical School Stroke Institute

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  • 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.