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NCT Number: NCT07536906

Falls Validation Study

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.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada

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About this study

Traumatic intracranial bleeding is much more prevalent in older adults and has a much worse prognosis as compared to the younger population. Older adults are at risk of traumatic intracranial bleeding because there is loss of the elastic integrity of the cerebral bridging veins and brain atrophy, allowing rapid movements of the brain with trauma. The vast majority of traumatic intracranial bleeding diagnoses in older adults result from low-energy falls from standing or sitting.

In 2015, the Canadian Medical Association called for a national strategy for older adults that would include evidence-based hospital practices. In 2021-22, older adults accounted for about 25% of all Canadian emergency department visits, and older adults who had fallen account for over 3% of visits. This number continues to rise. A conservative estimation using 2022 Canadian Institute of Health Information data suggests there are at least 500,000 emergency department visits from older adults after a fall annually in Canada, yet there is little research evidence to guide testing for intracranial bleeding.

It is difficult for physicians to determine the risk of intracranial bleeding when an older patient has fallen. Diagnosing fall-related intracranial bleeding is an important part of the emergency department assessment. It is critical that older patients with intracranial bleeding are identified early so that they are provided with appropriate medical and neurosurgical care

To address the lack of evidence-based guidance specific to older adults who fall, the Falls Decision Rule was derived to guide the use of brain imaging.

Validation of the Falls Rules would improve image utilization for older adults who have fallen, meaning that intracranial bleeding would be diagnosed on the first emergency department visit. People with very low risk of intracranial bleeding would not need brain imaging which facilitates a faster discharge from the emergency department.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Clinical Decision Rule

Other

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

Primary outcomes

  1. Clinically Important Intracranial Bleeding

    Time frame: 30 days

    Intracranial bleeding diagnosed at the index emergency department visit or within 30 days. Clinically important intracranial bleeding is defined as bleeding within the cranial vault (including subdural, intracerebral, intraventricular, subarachnoid, epidural blood, and cerebral contusion), which subsequently requires medical or surgical intervention for the bleed or causes death.

Secondary outcomes

  1. Clinically Unimportant Intracranial Bleeding

    Time frame: 30 days

    Adjudicated intracranial bleeding within 30 days which does not meet our definition of clinically important.

  2. Delayed Intracranial Bleeding

    Time frame: 30 days

    Intracranial bleeding diagnosed after the emergency department visit until day 30

  3. Death

    Time frame: 120 days

    Death within 120 days of the index emergency department visit

  4. Recurrent Falls

    Time frame: 120 days

    Evidence that the patient fell at least 1 time after the index emergency department visit.

Study contacts

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

Natasha Clayton, Clinical Trial Manager, CRA, RA

CONTACT

[email protected]

416-566-3590

Sponsors and collaborators

Lead sponsor

Dr. Kerstin de Wit

Other

Collaborators

  • Network of Canadian Emergency Researchers (NCER)

Registry information

Official study title

Validation of the Falls Decision Rule for Diagnosing Intracranial Bleeding in Older Adults After a Fall

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 17, 2026
Registry last updated
May 27, 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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