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Restarting Anticoagulation After Traumatic Intracranial Hemorrhage

ConditionsHemorrhageIntracranial HemorrhagesBleedingTrauma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas at Austin

About 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 does not accept healthy volunteers

Qualifiers

Acute traumatic intracranial hemorrhage on anticoagulation for Atrial Fibrillation (AF) or Venous Thromboembolism (VTE) or both (2,500 patients per year at our 40 sites)

Patient is higher risk for stroke or other thrombotic events as witnessed by having a CHA2DS2-VASc score of > 3 (at least 3 of the following risk factors: age greater than 65,( age > 75 counts for two points), history of stroke or TIA, history of heart failure, history of diabetes, history of atherosclerotic vascular disease, female gender, history of hypertension) (Excludes 20% or 500 patients per year)

Disqualifiers

Mechanical Valve

Ventricular Assist Device (VAD)

SDH >8 mm maximum width or any midline shift at any time point or more than one SDH

Physician plan to start/restart antiplatelet therapy during trial period

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anticoagulants

    Drug

    DOAC for the prevention of thromboembolic events in patients with non-valvular AF or VTE.

Treatment groups

1,100 Participants
are divided into 3 treatment groups
Group A: 1 weekExperimental treatment 1 intervention
Group B: 2 weeksExperimental treatment 1 intervention
Group C: 4 weeksExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

60 Day Composite of Thrombotic and Bleeding Events

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.

Time frame
60 days following index bleeding event

Secondary outcomes

1

60 Day Disability Rating Scale (1-29 with 29 being worse)

DRS is a scale to measure disability after an injury

Time frame
60 days following index bleeding event
2

60 Day Modified Rankin Scale (1-6 with 6 being worse)

The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

Time frame
60 days following index bleeding event
3

Standard Gamble Patient Reported utilities for endpoints

Performed prior to randomization and immediately after each endpoint

Time frame
pre-randomization and after endpoints

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas at Austin

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: