Restarting Anticoagulation After Traumatic Intracranial Hemorrhage (Restart tICrH)
Hemorrhage, Intracranial Hemorrhages, Bleeding
About this trial
This is an interventional prevention trial for Hemorrhage focused on measuring Anticoagulation, Anticoagulant, Anticoagulants, Restart, Delay, Hemorrhage, ICH, SAH, SDH, DOAC, NOAC, apixaban, rivaroxaban, edoxaban
Eligibility Criteria
Inclusion Criteria:
Entry into the trial is primarily driven pragmatically by clinician intent to restart a Direct Oral Anticoagulant (DOAC) after anticoagulant-associated traumatic intracranial hemorrhage and equipoise concerning restart of anticoagulation at the specified time intervals. DOAC will be at label dose with label adjustments for creatinine clearance. DOAC will be at continuation dose, i.e. not initial therapy high doses in the setting of VTE.
- 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)
Exclusion Criteria:
- 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
- Acute Injury Score other than head >=3
- Pregnancy
- Inability to understand need for adherence to study protocol
- Renal function below DOAC label exclusions
- Any active pathological bleeding (e.g. no acute blood on most recent CT)
- Hypersensitivity to drug or other label contraindication
- Any bleeding that the investigator deems unsafe to restart DOAC at 1 week post injury, or conversely unsafe to hold DOAC to 4 weeks
- Expected completion of DOAC therapy expected prior to 60 day primary outcome, e.g. 3-6 month VTE therapy
- Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4
Sites / Locations
- Dell Seton Medical Center at The University of Texas
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
1 week
2 weeks
4 weeks
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.
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.
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.