CClinicalTrials.gg
RecruitingNCT07536906Updated May 27, 2026

Falls Validation Study

An observational study in Intracranial Bleed and Falls, sponsored by Dr. Kerstin de Wit. Recruiting at 7 sites in 2 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Dr. Kerstin de Wit · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Intracranial Bleed
  • Falls

Keywords

  • Falls
  • Intracranial Bleeding
  • Head CT
  • Computed Tomography
  • Clinical Decision Rule
03

In context

Intracranial Hemorrhages

199 studies on the registry are indexed under Intracranial Hemorrhages; 64 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 240 across 87 observational studies indexed under Intracranial Hemorrhages.

Browse Intracranial Hemorrhages studies →

Lead sponsor

Dr. Kerstin de Wit is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who present to the emergency department.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cohort 1

    Older adults who fall within 48 hours of emergency department visit

    Other: Clinical Decision Rule

Interventions

  • OtherClinical Decision Rule

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

06

What researchers measure

Primary outcomes

  1. Clinically Important Intracranial Bleeding

    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.

    Time frame: 30 days

Secondary outcomes

  1. Clinically Unimportant Intracranial Bleeding

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

    Time frame: 30 days

  2. Delayed Intracranial Bleeding

    Intracranial bleeding diagnosed after the emergency department visit until day 30

    Time frame: 30 days

  3. Death

    Death within 120 days of the index emergency department visit

    Time frame: 120 days

  4. Recurrent Falls

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

    Time frame: 120 days

07

Study locations

1 of 7 sites recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02115, United States
    • Shan Liu, MD · Principal investigator
    Not yet recruiting
  • Hamilton Health Sciences Corporation
    Hamilton, Ontario L8L 2X2, Canada
    • Natasha Clayton · Contact · claytonn@hhsc.ca · 416-566-3590
    • Alim Pardhan, MD · Principal investigator
    Not yet recruiting
  • Kingston Health Sciences Centre
    Kingston, Ontario K7L 2V7, Canada
    Recruiting
  • Ottawa Hospital Research Institute
    Ottawa, Ontario, Canada
    • Gabriel Sandino-Gold · Contact · gsandino@ohri.ca · 613-798-5555
    • Ian Stiell, MD · Principal investigator
    Not yet recruiting
  • Sinai Health System
    Toronto, Ontario M5G 1X5, Canada
    Not yet recruiting
  • Centre Intégré Universitaire De Santé Et De Services Sociaux Du Nord-De-L'île-De-Montréal,
    Montreal, Quebec H3L 1K5, Canada
    • Justine Lessard, MD · Principal investigator
    Not yet recruiting
  • CHU de Québec - Université Laval
    Québec, Quebec, Canada
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07536906
Lead sponsor
Dr. Kerstin de Wit
Collaborators
Network of Canadian Emergency Researchers (NCER)
Responsible party
Dr. Kerstin de Wit (Professor, Queen's University) — Sponsor-investigator
First posted
Apr 17, 2026
Start date
May 1, 2026
Primary completion
Apr 30, 2029 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
May 27, 2026

Study contacts

Natasha Clayton, Clinical Trial Manager, CRA, RA
Contact
natasha.clayton@queensu.ca
416-566-3590
Kerstin de Wit, MD
principal investigator · Queens University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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