RecruitingNot Applicable

Selective CT for Anticoagulated Head Injured Patients

Canada4,000 participantsStarted 2022-02-01

Plain-language 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.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinically important traumatic brain injury

Timeframe: Index emergency department presentation

Trial details

NCT IDNCT05364749

SponsorDr. Kerstin de Wit

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-15

Contact for this trial

Natasha Clayton, CRA, RA

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

View on ClinicalTrials.gov More Head Injury trials