Clinical trial NCT05364749: Selective CT for Anticoagulated Head Injured Patients
Official title: Selective Neuroimaging for Head-injured Emergency Patients Who Take Anticoagulant Medication
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head Injury
Traumatic Brain Injury
Intracranial Hemorrhage, Traumatic
Blunt Head Injury
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-05-06
Enrollment: 4000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study enrolls a anticoagulated emergency department patients presenting within 48 hours of a blunt head injury.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥16 years
* Presents to the emergency department after a head injury
* Patient has a head CT in the emergency department
* Is a current anticoagulant user

Exclusion Criteria:

* Head injury occurred \>48 h before patient's arrival to the emergency department
* Penetrating head injury
* Previously enrolled
* Patient resides outside of the hospital's catchment area
* Patient was transferred from another emergency department following neuroimaging
* Patient was not managed by the emergency or trauma physician in the emergency department
* Leaves the emergency department prior to completion of their medical assessment

Primary outcomes:
measure: Clinically important traumatic brain injury
timeFrame: Index emergency department presentation
Secondary outcomes:
measure: Delayed clinically important traumatic brain injury
timeFrame: Diagnosed within 30 days of a negative index head CT scan at the index emergency department presentation
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Sinai Health
state: Ontario
city: Montréal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
city: Québec City
country: Canada
facility: CHU de Québec - Université Laval
state: Quebec
Study officials:
affiliation: Queens University
name: Kerstin de Wit, MD
role: PRINCIPAL_INVESTIGATOR
References: