Status:
UNKNOWN
Restart TICrH Alpha Pilot Protocol, Restarting DOACs After Traumatic Intracranial Hemorrhage
Lead Sponsor:
University of Texas at Austin
Collaborating Sponsors:
University of Kansas
Conditions:
Anticoagulants; Increased
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
Randomized pilot trial of restarting DOACs at 1 week versus 4 weeks after traumatic intracranial hemorrhage
Detailed Description
Restart TICrH two-center pilot trial will assign patients with anticoagulant-associated traumatic intracranial hemorrhage to restart anticoagulation at 1 week or 4 weeks. Entry into the trial is prima...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
- Completion of DOAC therapy expected prior to 60 day primary endpoint, e.g. 3-6 month VTE treatment
- Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4
- Low body weight (\<45kg)
- Inability to swallow
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04891861
Start Date
July 1 2021
End Date
July 1 2023
Last Update
May 19 2021
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