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NCT Number: NCT05364749

Selective CT for Anticoagulated Head Injured Patients

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.

Recruiting

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

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 clinical predictors for traumatic brain injury at the time of assessment. All patients will undergo head CT scanning and are followed for 30 days.

The adjudicated primary outcome is clinically important traumatic brain injury diagnosed at the index ED presentation. The secondary outcome is delayed clinically important traumatic brain injury, diagnosed within 30 days of normal index head CT scan.

The primary analysis will be to derive a novel clinical decision rule which excludes clinically important traumatic brain injury diagnosed at the index ED visit. The secondary analyses will include:

  • The diagnostic accuracy of existing head injury clinical decision rules in diagnosing clinically important traumatic brain injury on index ED visit, in patients who take anticoagulation; and,
  • The sensitivity and specificity of the new and existing rules for the diagnosis of both index and delayed clinically important traumatic brain injury.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinically important traumatic brain injury

    Time frame: Index emergency department presentation

    Clinically important TBI is defined as the diagnosis of bleeding within the cranial vault, diffuse axonal injury or an isolated skull fracture, which also receives hospital intervention or causes death within 90 days of the traumatic brain injury diagnosis.

Secondary outcomes

  1. Delayed clinically important traumatic brain injury

    Time frame: Diagnosed within 30 days of a negative index head CT scan at the index emergency department presentation

    Clinically important TBI is defined as the diagnosis of bleeding within the cranial vault, diffuse axonal injury or an isolated skull fracture, which also receives hospital intervention or causes death within 90 days of the traumatic brain injury diagnosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Natasha Clayton, CRA, RA

CONTACT

[email protected]

416-566-3590

Sponsors and collaborators

Lead sponsor

Dr. Kerstin de Wit

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Selective Neuroimaging for Head-injured Emergency Patients Who Take Anticoagulant Medication

Acronym: Can-SCAHn

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
May 6, 2022
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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