Selective CT for Anticoagulated Head Injured Patients

Recruiting

• Conditions: Traumatic Brain Injury; Intracranial Hemorrhage, Traumatic; Blunt Head Injury; Head Injury

• Registration Number: NCT05364749
• Lead Sponsor: Dr. Kerstin de Wit

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.

Study Timeline

• Study Start: 2022-03-17
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2026-02-28
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Delayed clinically important traumatic brain injury	Diagnosed within 30 days of a negative index head CT scan at the 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 Locations

Locations (7)

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Hamilton Health Sciences Corporation; 🇨🇦 Hamilton, Ontario, Canada

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada

Sinai Health; 🇨🇦 Toronto, Ontario, Canada

Hôpital du Sacré-Cœur de Montréal; 🇨🇦 Montréal, Quebec, Canada

CHU de Québec - Université Laval; 🇨🇦 Québec City, Quebec, Canada