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Falls Validation Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07536906
Enrollment
4000
Registered
2026-04-17
Start date
2026-05-01
Completion date
2030-12-30
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falls, Intracranial Bleed

Keywords

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

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.

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.

Interventions

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

Sponsors

Dr. Kerstin de Wit
Lead SponsorOTHER
Network of Canadian Emergency Researchers (NCER)
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinically Important Intracranial Bleeding30 daysIntracranial 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

MeasureTime frameDescription
Clinically Unimportant Intracranial Bleeding30 daysAdjudicated intracranial bleeding within 30 days which does not meet our definition of clinically important.
Delayed Intracranial Bleeding30 daysIntracranial bleeding diagnosed after the emergency department visit until day 30
Death120 daysDeath within 120 days of the index emergency department visit
Recurrent Falls120 daysEvidence that the patient fell at least 1 time after the index emergency department visit.

Countries

Canada, United States

Contacts

CONTACTNatasha Clayton, Clinical Trial Manager, CRA, RA
natasha.clayton@queensu.ca416-566-3590
PRINCIPAL_INVESTIGATORKerstin de Wit, MD

Queens University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026