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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Neuroimaging for Head-injured Emergency Patients Who Take Anticoagulant Medication
- ClinicalTrials.gov ID
- NCT05364749
- Acronym / sponsor ID
- Can-SCAHn / 202104PJ2-461744
- Conditions
- Head Injury, Traumatic Brain Injury, Intracranial Hemorrhage, Traumatic, Blunt Head Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Dr. Kerstin de WitUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study enrolls a anticoagulated emergency department patients presenting within 48 hours of a blunt head injury.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically important traumatic brain injury
Time frame: 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.
1 secondary outcome
Delayed clinically important traumatic brain injury
Time frame: Diagnosed within 30 days of a negative index head CT scan at the index emergency department presentation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Head Injury
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Nanopulse Laser Therapy
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RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerstin de Wit, MD principal investigator
Queens University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury and Traumatic Brain Injury, run by Dr. Kerstin de Wit at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Clayton, CRA, RA (416-566-3590, natasha.clayton@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically important traumatic brain injury (time frame: Index emergency department presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.