Restarting Anticoagulation After Traumatic Intracranial Hemorrhage

Launched by UNIVERSITY OF TEXAS AT AUSTIN · Jan 13, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the best timing for restarting blood-thinning medications, known as anticoagulants, after a patient has experienced a traumatic brain bleed (intracranial hemorrhage). The goal is to find out whether restarting these medications one week, two weeks, or four weeks after the injury can help prevent serious problems like blood clots while keeping patients safe from further bleeding. The trial will involve about 2,500 patients each year who have a higher risk of blood clots due to conditions like atrial fibrillation (irregular heartbeat) or previous blood clots.

To participate in this trial, patients must have had a recent brain bleed and be on anticoagulants for their underlying conditions. They should also have a certain level of risk for stroke, as determined by a scoring system. The trial is not yet recruiting participants, but if someone is eligible, they can expect to be closely monitored for 60 days to see how well they do after restarting their anticoagulants at different times. This study is important because it aims to improve how doctors manage anticoagulation in patients who have suffered a serious brain injury, balancing the risks of bleeding and blood clots.

Gender

ALL

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.
• • 1. 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)
• • 2. 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:
• • 1. Mechanical Valve
• • 2. Ventricular Assist Device (VAD)
• • 3. SDH \>8 mm maximum width or any midline shift at any time point or more than one SDH
• • 4. Physician plan to start/restart antiplatelet therapy during trial period
• • 5. Acute Injury Score other than head \>=3
• • 6. Pregnancy
• • 7. Inability to understand need for adherence to study protocol
• • 8. Renal function below DOAC label exclusions
• • 9. Any active pathological bleeding (e.g. no acute blood on most recent CT)
• • 10. Hypersensitivity to drug or other label contraindication
• • 11. Any bleeding that the investigator deems unsafe to restart DOAC at 1 week post injury, or conversely unsafe to hold DOAC to 4 weeks
• • 12. Expected completion of DOAC therapy expected prior to 60 day primary outcome, e.g. 3-6 month VTE therapy
• • 13. Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4