Timing of Anticoagulation After Intracranial Hemorrhage
(Restart tICrH Trial)

Recruiting in Palo Alto (17 mi)

Overseen byTruman J Milling, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Texas at Austin

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

This trial is for patients who've had a traumatic brain bleed while on blood thinners for atrial fibrillation or clot prevention. They should be at high risk of stroke, with specific criteria met (CHA2DS2-VASc score >3), and their doctors are considering restarting anticoagulants within 1 to 4 weeks after the bleeding event.

Inclusion Criteria

I am at high risk for stroke with a CHA2DS2-VASc score over 3.

I have a recent brain bleed while on blood thinners for AF or VTE.

My doctor plans to restart my blood thinner medication after a brain bleed.

Exclusion Criteria

If you have bleeding that your doctor thinks is not safe to start or stop a specific medication after a week or four weeks.

I am not taking medication that strongly affects certain liver enzymes.

You are allergic to the drug or have a specific reason not to take it according to the label.

+10 more

Participant Groups

The study tests when it's best to restart blood thinners (DOACs) after a brain bleed due to injury: at 1 week, 2 weeks, or 4 weeks. The goal is to balance preventing clots against the risk of more bleeding. It uses random assignment and looks at thrombotic and bleeding events over two months.

3Treatment groups

Experimental Treatment

Group I: 4 weeksExperimental Treatment1 Intervention

Time to delay the initiation of anticoagulation is determined at randomization. Patients will be randomized to initiate anticoagulation 1 week, 2 weeks, or 4 weeks following injury.

Group II: 2 weeksExperimental Treatment1 Intervention

Time to delay the initiation of anticoagulation is determined at randomization. Patients will be randomized to initiate anticoagulation 1 week, 2 weeks, or 4 weeks following injury.

Group III: 1 weekExperimental Treatment1 Intervention

Time to delay the initiation of anticoagulation is determined at randomization. Patients will be randomized to initiate anticoagulation 1 week, 2 weeks, or 4 weeks following injury.