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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 week restart | Experimental | Restart of mono or dual antiplatelet therapy one week post injury in TICrH patients |
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| 3 week restart | Active Comparator | Usual Care for restart of mono or dual antiplatelet therapy after TICrH at clinician's discretion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing/1 week | Other | Time of restart of antiplatelet therapy is one week after injury |
| |
| Measure | Description | Time Frame |
|---|---|---|
| major bleeding | Recurrent ICrH or other major bleeding defined by BARC3A | 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 | Baseline (gambles performed pre-randomization) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Truman J Milling, MD | Contact | 15124969742 | tjmilling@yahoo.com | |
| Ashkan J Shoamanesh, MD PhD | Contact | ashkan.shoamanesh@phri.ca |
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Data sharing with NIH BIOLINCC
2 years from study launch
per NIH policy
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| ID | Term |
|---|---|
| D020198 | Intracranial Hemorrhage, Traumatic |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Prospective Randomized Open Label Blinded Endpoint pilot trial of 100 patients
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Blinded assessment and adjudication of endpoints
| Timing/3 weeks |
| Other |
Time of restart of antiplatelet therapy is left to treating clinician discretion |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014947 | Wounds and Injuries |