UnknownPhase 3

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

100 participantsStarted 2021-07-01

Plain-language summary

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

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Mechanical Valve or 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
✕. Abbreviated Injury Scale 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)

60-day composite endpoint

Timeframe: 60 days

NCT IDNCT04891861

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-01

Truman J Milling, MD