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: 1. Derive and externally validate a new highly sensitive and maximally specific clinical decision rule for the exclusion of traumatic brain injury in head-injured ED patients who take anticoagulant medications; and, 2. Estimate the sensitivity and specificity of existing head injury clinical decision rules in head-injured ED patients who take anticoagulant medications.
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: 1. The diagnostic accuracy of existing head injury clinical decision rules in diagnosing clinically important traumatic brain injury on index ED visit, in patients who take anticoagulation; and, 2. The sensitivity and specificity of the new and existing rules for the diagnosis of both index and delayed clinically important traumatic brain injury.
Study Type
OBSERVATIONAL
Enrollment
4,000
University of British Columbia
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGHamilton Health Sciences Corporation
Hamilton, Ontario, Canada
NOT_YET_RECRUITINGKingston Health Sciences Centre
Kingston, Ontario, Canada
RECRUITINGOttawa Hospital Research Institute
Ottawa, Ontario, Canada
NOT_YET_RECRUITINGSinai Health
Toronto, Ontario, Canada
NOT_YET_RECRUITINGHôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada
NOT_YET_RECRUITINGCHU de Québec - Université Laval
Québec, Quebec, Canada
NOT_YET_RECRUITINGClinically 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.
Time frame: Index emergency department presentation
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.
Time frame: Diagnosed within 30 days of a negative index head CT scan at the index emergency department presentation
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