NCT07536906

Falls Validation Study

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Dr. Kerstin de Wit · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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. We have created 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. We will check this this decision rule 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, we derived the Falls Decision Rule 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.

Conditions

• Intracranial Bleed
• Falls

Interventions

Type	Name	Description
OTHER	Clinical Decision Rule	The Falls Decision Rule will help guide emergency physicians when to obtain brain imaging and when brain imaging is not required.

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-04-30
• Completion: 2030-12-30
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

5 sites across 1 country: Canada