Recruiting

Decision Rule

Sponsor:

Dr. Kerstin de Wit

Code:

NCT07536906

Conditions

Intracranial Bleed

Falls

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Clinical Decision Rule

Study Details

Brief summary:

Each year, one in three adults over the age of 65 has a fall. These falls lead to half a million Canadian emergency department patient visits annually and falls in older adults account for more than 3% of all emergency department visits.

A rapid, simple bedside test (known as a decision rule) to guide emergency physicians on when older adults should have a brain scan to diagnose traumatic brain bleeding was created. This decision rule will be checked to see if it works well in guiding who needs a brain scan.

Conditions

Intracranial Bleed

Falls

Study ID

NCT07536906

Start date

May 1, 2026

Status verified date

May, 2026

Completion date

Dec 30, 2030

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 65 or older
  • Present to the emergency department within 48 hours of having a fall
  • Fall from standing, from a chair, toilet seat, or bed

Exclusion Criteria:

  • Transferred from another hospital organization after brain imaging
  • Leave the emergency department prior to completion of their medical assessment
  • Previously enrolled
  • Lives outside the hospital catchment area

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Older adults who fall within 48 hours of emergency department visit

Interventions

Clinical Decision Rule

The Falls Decision Rule will help guide emergency physicians when to obtain brain imaging and when brain imaging is not required.

Primary outcome measure

  • Clinically Important Intracranial Bleeding [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Natasha Clayton, Clinical Trial Manager, CRA, RA

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

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Natasha Clayton

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

Principal Investigator:

Isabelle Gray, MD

More Information

Sponsor

Dr. Kerstin de Wit

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

  • Falls
  • Intracranial Bleeding
  • Head CT
  • Computed Tomography
  • Clinical Decision Rule

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 2026-05-27.