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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
100
Time of restart of antiplatelet therapy is one week after injury
Time of restart of antiplatelet therapy is left to treating clinician discretion
major bleeding
Recurrent ICrH or other major bleeding defined by BARC3A
Time frame: 60 days
Major Vascular Occlusive events
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
Time frame: Baseline (gambles performed pre-randomization)
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