Head InjuryCan-SCAHnNCT05364749
Selective CT for Anticoagulated Head Injured Patients
An observational study of Head Injury and Traumatic Brain Injury, run by Dr. Kerstin de Wit at 7 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Head Injury, Traumatic Brain Injury, Intracranial Hemorrhage, Traumatic
- How many people
- 4,000 participants
- Where
- 7 sitesCanada
- Study dates
- 1 Feb 2022to 30 Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: The study enrolls a anticoagulated emergency department patients presenting within 48 hours of a blunt head injury.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Not yet recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 2X2
Natasha S Clayton, CRA, RA, claytonn@hhsc.ca
Alim Pardhan, MD
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, N3T 6P9
Natasha S Clayton, CRA, RA, natasha.clayton@queensu.ca
Kerstin de Wit, MD
- Not yet recruiting
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
Chantal Lanthier, RN
Justine Lessard, MD
- Not yet recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Gabriel Sandino-Gold
Debra Eagles, MD
- Not yet recruiting
CHU de Québec - Université Laval
Québec, Quebec, G1R 2J6
Alexandra Nadeau
Éric Mercier, MD
- Not yet recruiting
Sinai Health
Toronto, Ontario, M5G 1X5
Shelley McLeod, PhD, MSc
Catherine Varner, MD
- Not yet recruiting
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
David Barbic, MD
David Barbic, MD
About this study
Official title: 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:
- 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,
- Estimate the sensitivity and specificity of existing head injury clinical decision rules in head-injured ED patients who take anticoagulant medications.
Read the 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:
- 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,
- The sensitivity and specificity of the new and existing rules for the diagnosis of both index and delayed clinically important traumatic brain injury.
- Conditions
- Head Injury, Traumatic Brain Injury, Intracranial Hemorrhage, Traumatic, Blunt Head Injury
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic, Intracranial Hemorrhage, Traumatic, Head Injuries, Closed
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Index emergency department presentation
Secondary outcomes (1)
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.
Measured: Diagnosed within 30 days of a negative index head CT scan at the index emergency department presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 Feb 2022
- Primary completion15 Mar 2026
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Kerstin de Wit
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Dr. Kerstin de Wit, Queen's University
- Investigators
- Kerstin de Wit, MD, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364749
- Sponsor's protocol ID
- 202104PJ2-461744
- Acronym
- Can-SCAHn
- Status last verified
- Apr 2026
- First submitted
- 3 May 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No