Recruiting

Clinical Decision Rule

Sponsor:

Dr. Kerstin de Wit

Code:

NCT05364749

Conditions

Head Injury

Traumatic Brain Injury

Intracranial Hemorrhage, Traumatic

Blunt Head Injury

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Study Details

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 to:

1. 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,
2. Estimate the sensitivity and specificity of existing head injury clinical decision rules in head-injured ED patients who take anticoagulant medications.

Conditions

Head Injury

Traumatic Brain Injury

Intracranial Hemorrhage, Traumatic

Blunt Head Injury

Study ID

NCT05364749

Start date

Feb 1, 2022

Status verified date

Apr, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Mar 15, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Clinically important traumatic brain injury [ Time Frame: Index emergency department presentation ]

Central Contacts and Locations

Central contacts

Natasha Clayton, CRA, RA

416-566-3590natasha.clayton@queensu.ca

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, N3T 6P9

Contacts

Natasha S Clayton, CRA, RA

natasha.clayton@queensu.ca

Principal Investigator:

Kerstin de Wit, MD

More Information

Sponsor

Dr. Kerstin de Wit

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Kerstin de Wit on 2026-04-14.