Selective CT for Anticoagulated Head Injured Patients (Can-SCAHn)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Natasha Clayton, CRA, RA; Phone Number: 416-566-3590; Email: natasha.clayton@queensu.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z4
      • Not yet recruiting
      • University of British Columbia
      • Contact: David Barbic, MD
      • Principal Investigator: David Barbic, MD
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Not yet recruiting
      • Hamilton Health Sciences Corporation
      • Contact: Natasha S Clayton, CRA, RA; Email: claytonn@hhsc.ca
      • Principal Investigator: Alim Pardhan, MD
    • Kingston, Ontario, Canada, N3T 6P9
      • Recruiting
      • Kingston Health Sciences Centre
      • Contact: Natasha S Clayton, CRA, RA; Email: natasha.clayton@queensu.ca
      • Principal Investigator: Kerstin de Wit, MD
    • Ottawa, Ontario, Canada, K1H 8L6
      • Not yet recruiting
      • Ottawa Hospital Research Institute
      • Contact: Gabriel Sandino-Gold
      • Principal Investigator: Debra Eagles, MD
    • Toronto, Ontario, Canada, M5G 1X5
      • Not yet recruiting
      • Sinai Health
      • Contact: Shelley McLeod, PhD, MSc
      • Principal Investigator: Catherine Varner, MD
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Not yet recruiting
      • Hopital du Sacre-Coeur de Montreal
      • Contact: Chantal Lanthier, RN
      • Principal Investigator: Justine Lessard, MD
    • Québec, Quebec, Canada, G1R 2J6
      • Not yet recruiting
      • CHU de Québec - Université Laval
      • Contact: Alexandra Nadeau
      • Principal Investigator: Éric Mercier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study enrolls a anticoagulated emergency department patients presenting within 48 hours of a blunt head injury.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Kerstin de Wit
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Kerstin de Wit, MD, Queens University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): March 15, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Trauma, Nervous System; Wounds, Nonpenetrating; Intracranial Hemorrhages; Brain Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Head Injuries, Closed; Intracranial Hemorrhage, Traumatic
• Other Study ID Numbers: 202104PJ2-461744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No