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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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The goal is to derive and a clinical decision rule for safe exclusion of traumatic brain injury without neuroimaging in head-injured ED patients who take anticoagulant medications.
The objectives are to:
This is a prospective cohort study enrolling 4000 anticoagulated patients presenting with blunt head trauma to the emergency department. Emergency physicians will record the presence or absence of clinical predictors for traumatic brain injury at the time of assessment. All patients will undergo head CT scanning and are followed for 30 days.
The adjudicated primary outcome is clinically important traumatic brain injury diagnosed at the index ED presentation. The secondary outcome is delayed clinically important traumatic brain injury, diagnosed within 30 days of normal index head CT scan.
The primary analysis will be to derive a novel clinical decision rule which excludes clinically important traumatic brain injury diagnosed at the index ED visit. The secondary analyses will include:
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| Measure | Description | Time Frame |
|---|---|---|
| Clinically important traumatic brain injury | Clinically important TBI is defined as the diagnosis of bleeding within the cranial vault, diffuse axonal injury or an isolated skull fracture, which also receives hospital intervention or causes death within 90 days of the traumatic brain injury diagnosis. | Index emergency department presentation |
| Measure | Description | Time Frame |
|---|---|---|
| Delayed clinically important traumatic brain injury | Clinically important TBI is defined as the diagnosis of bleeding within the cranial vault, diffuse axonal injury or an isolated skull fracture, which also receives hospital intervention or causes death within 90 days of the traumatic brain injury diagnosis. | Diagnosed within 30 days of a negative index head CT scan at the index emergency department presentation |
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Inclusion Criteria:
Exclusion Criteria:
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The study enrolls a anticoagulated emergency department patients presenting within 48 hours of a blunt head injury.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natasha Clayton, CRA, RA | Contact | 416-566-3590 | natasha.clayton@queensu.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kerstin de Wit, MD | Queens University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Not yet recruiting | Vancouver | British Columbia | V6T 1Z4 | Canada |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D000070642 | Brain Injuries, Traumatic |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D016489 | Head Injuries, Closed |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
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| Hamilton Health Sciences Corporation | Not yet recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| Kingston Health Sciences Centre | Recruiting | Kingston | Ontario | N3T 6P9 | Canada |
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| Ottawa Hospital Research Institute | Not yet recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| Sinai Health | Not yet recruiting | Toronto | Ontario | M5G 1X5 | Canada |
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| Hôpital du Sacré-Cœur de Montréal | Not yet recruiting | Montreal | Quebec | H4J 1C5 | Canada |
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| CHU de Québec - Université Laval | Not yet recruiting | Québec | Quebec | G1R 2J6 | Canada |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014949 | Wounds, Nonpenetrating |