Restart TICrH Alpha Pilot Protocol, Restarting DOACs After Traumatic Intracranial Hemorrhage

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized pilot trial of restarting DOACs at 1 week versus 4 weeks after traumatic intracranial hemorrhage

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas at Austin
• Collaborator: University of Kansas
• Treatments: Apixaban; Dabigatran; Edoxaban; Rivaroxaban

Criteria

Inclusion Criteria:

1. Acute traumatic intracranial hemorrhage on anticoagulation for Atrial Fibrillation (AF) or Venous Thromboembolism (VTE)

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 2 points), history of stroke or TIA (2 points), history of heart failure, history of diabetes, history of atherosclerotic vascular disease, female biological sex, history of hypertension)

3. DOAC prescribed at label dose with creatinine clearance adjustments. DOAC at continuation dose, i.e., not initial therapy high doses in the setting of VTE

Exclusion Criteria:

1. Mechanical Valve or Ventricular Assist Device (VAD)

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

3. Physician plan to start/restart antiplatelet therapy during trial period

4. Abbreviated Injury Scale other than head >3

5. Pregnancy

6. Inability to understand need for adherence to study protocol

7. Renal function below DOAC label exclusions

8. Any active pathological bleeding (e.g. no acute blood on most recent CT)

9. Hypersensitivity to drug or other label contraindication

10. Any bleeding that the investigator deems unsafe to restart DOAC at 1 week post injury, or conversely unsafe to hold DOAC to 4 weeks

11. Completion of DOAC therapy expected prior to 60 day primary endpoint, e.g. 3-6 month VTE treatment

12. Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4

13. Low body weight (<45kg)

14. Inability to swallow