Status:
RECRUITING
Selective CT for Anticoagulated Head Injured Patients
Lead Sponsor:
Dr. Kerstin de Wit
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Head Injury
Traumatic Brain Injury
Eligibility:
All Genders
16+ years
Brief 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...
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 cli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT05364749
Start Date
March 17 2022
End Date
September 30 2027
Last Update
May 10 2024
Active Locations (7)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z4
2
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8L 2X2
3
Kingston Health Sciences Centre
Kingston, Ontario, Canada, N3T 6P9
4
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6