Developing a decision rule for safely assessing head injuries in patients on blood thinners

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kingston Health Sciences Centre
  Kingston, Ontario, Canada Recruiting
• University of British Columbia
  Vancouver, British Columbia, Canada Not yet recruiting
• Hamilton Health Sciences Corporation
  Hamilton, Ontario, Canada Not yet 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.