Selective CT for Anticoagulated Head Injured Patients

Traumatic Brain Injury Clinical Trial

— Can-SCAHn  

Official title:

Selective Neuroimaging for Head-injured Emergency Patients Who Take Anticoagulant Medication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364749
• Other study ID #: 202104PJ2-461744
• Status: Recruiting
• Start date: March 17, 2022
• Est. completion date: September 30, 2027

Study information

• Verified date: May 2024
• Source: Queen's University
• Contact: Natasha Clayton, CRA, RA
• Phone: 416-566-3590
• Email: natasha.clayton[@]queensu.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: September 30, 2027
• Est. primary completion date: February 28, 2026
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma
• Head Injuries, Closed
• Head Injury
• Hemorrhage
• Intracranial Hemorrhage, Traumatic
• Intracranial Hemorrhages
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	Hôpital du Sacré-Cœur de Montréal	Montréal	Quebec
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	CHU de Québec - Université Laval	Québec City	Quebec
Canada	Sinai Health	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Kerstin de Wit	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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