Selective CT for Anticoagulated Head Injured Patients

NCT05364749 · tracked via the Priya Life Science Canada tracker

Sponsor

Dr. Kerstin de Wit

Phase

Observational

Started

2022-02-01

Last updated

2026-04-14

Condition(s) studied

Head InjuryTraumatic Brain InjuryIntracranial Hemorrhage, TraumaticBlunt Head Injury

Study 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.

Eligibility

Sex

ALL

Min age

16 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Clinically important traumatic brain injury — Index emergency department presentation
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.

Trial sites (7)

Facility	City	Region	Status
University of British Columbia	Vancouver	British Columbia	Not Yet Recruiting
Hamilton Health Sciences Corporation	Hamilton	Ontario	Not Yet Recruiting
Kingston Health Sciences Centre	Kingston	Ontario	Recruiting
Ottawa Hospital Research Institute	Ottawa	Ontario	Not Yet Recruiting
Sinai Health	Toronto	Ontario	Not Yet Recruiting
Hôpital du Sacré-Cœur de Montréal	Montreal	Quebec	Not Yet Recruiting
CHU de Québec - Université Laval	Québec	Quebec	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05364749 on ClinicalTrials.gov ↗ ← All trials in Canada