Traumatic Intracranial Hemorrhage
Conditions
Keywords
restart, antiplatelet, traumatic intracranial hemorrhage
Brief summary
A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of restarting antiplatelet therapy at 1 week versus 3 weeks after traumatic intracranial hemorrhage with a primary composite endpoint of major bleeding and vascular occlusive events.
Interventions
OTHERTiming/1 week
Time of restart of antiplatelet therapy is one week after injury
OTHERTiming/3 weeks
Time of restart of antiplatelet therapy is left to treating clinician discretion
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded assessment and adjudication of endpoints
Intervention model description
Prospective Randomized Open Label Blinded Endpoint pilot trial of 100 patients
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Acute traumatic intracranial hemorrhage on either mono or dual antiplatelet therapy 2. History of stroke, vascular stent or coronary or peripheral arterial disease as indication for antiplatelet \*Restarting dual platelet therapy requires one of the following indications: 1) Acute myocardial infarction in the last year; 2) Coronary stent in the last year; 3) Non-cardioembolic stroke in the last 21 days (with switch to monotherapy at 21 days post stroke) 4) Peripheral arterial stent in the past month (with switch to monotherapy at one month post stent placement).
Exclusion criteria
1. SDH \>8 mm maximum width or any midline shift at any time point or more than one SDH 2. Physician plan to start/restart anticoagulant therapy during trial period 3. Abbreviated Injury Scale other than head \>3 4. Pregnancy 5. Inability to understand need for adherence to study protocol 6. Any active pathological bleeding (no acute blood on most recent CT) 7. Hypersensitivity to drug or other label contraindication 8. Any bleeding that the investigator deems unsafe to restart at 1 week post injury 9. Inability to swallow
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| major bleeding | 60 days | Recurrent ICrH or other major bleeding defined by BARC3A |
| Major Vascular Occlusive events | Baseline (gambles performed pre-randomization) | Ischemic stroke; myocardial infarction; mesenteric ischemia; peripheral arterial occlusion; deep vein thrombosis; pulmonary embolism; and carotid, coronary, or peripheral arterial revascularization procedures. Major vascular events defined by the Antithrombotic Trialists' Collaboration |
Contacts
Primary ContactTruman J Milling, MD
Backup ContactAshkan J Shoamanesh, MD PhD
Outcome results
None listed