Developing a decision rule for safely assessing head injuries in patients on blood thinners
Selective Neuroimaging for Head-injured Emergency Patients Who Take Anticoagulant Medication
This study is testing a new guideline to help doctors safely determine if patients on blood thinners have a serious head injury after a bump to the head.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 7 sites (Vancouver, British Columbia and 6 other locations) |
| Trial ID | NCT05364749 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create and validate a clinical decision rule that can safely exclude traumatic brain injury in patients who have experienced blunt head trauma while on anticoagulant medications. It will enroll 4,000 patients presenting to emergency departments, where emergency physicians will assess clinical predictors of traumatic brain injury. All participants will undergo head CT scans and will be monitored for 30 days to evaluate the accuracy of the new decision rule compared to existing ones. The study focuses on both immediate and delayed diagnoses of clinically important traumatic brain injury.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older who present to the emergency department with a head injury and are current users of anticoagulant medications.
Not a fit: Patients who have had a head injury more than 48 hours prior to arrival or those with penetrating head injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more efficient assessment protocols for head-injured patients on anticoagulants, reducing unnecessary imaging and associated risks.
How similar studies have performed: Other studies have explored clinical decision rules for head injuries, but this specific approach focusing on anticoagulated patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vancouver, British Columbia and 6 other locations
- University of British Columbia — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada (Not_yet_recruiting)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Not_yet_recruiting)
- Sinai Health — Toronto, Ontario, Canada (Not_yet_recruiting)
- Hôpital du Sacré-Cœur de Montréal — Montreal, Quebec, Canada (Not_yet_recruiting)
- CHU de Québec - Université Laval — Québec, Quebec, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Kerstin de Wit, MD — Queens University
- Study coordinator: Natasha Clayton, CRA, RA
- Email: natasha.clayton@queensu.ca
- Phone: 416-566-3590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.