Decision rule to detect brain bleeding after falls in older adults
Validation of the Falls Decision Rule for Diagnosing Intracranial Bleeding in Older Adults After a Fall
We will test a quick bedside decision rule to see if it can identify which people aged 65 and older who fell need a head CT to detect brain bleeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 7 sites (Boston, Massachusetts and 6 other locations) |
| Trial ID | NCT07536906 on ClinicalTrials.gov |
What this trial studies
This is a multicenter observational validation where clinicians will record a simple bedside decision rule and subsequent clinical care for older adults who present after a fall. Adults aged 65 or older presenting within 48 hours of a low-energy fall (standing, chair, bed, or toilet seat) at participating emergency departments will be enrolled. Head CT results and clinical outcomes will be used as the reference standard to measure the rule's sensitivity and specificity for detecting traumatic intracranial bleeding. The goal is to determine whether the rule reliably identifies patients who need imaging and those who can safely avoid it.
Who should consider this trial
Good fit: Ideal candidates are people aged 65 or older who present to a participating emergency department within 48 hours after a low-energy fall from standing, a chair, a toilet seat, or a bed and who live in the hospital catchment area.
Not a fit: Patients who were transferred after prior brain imaging, who leave the emergency department before completing assessment, who live outside the catchment area, or who were previously enrolled are not eligible and are unlikely to benefit from this validation.
Why it matters
Potential benefit: If successful, the rule could help doctors find intracranial bleeding earlier while reducing unnecessary head CT scans for low-risk older adults.
How similar studies have performed: Various head-injury decision rules have been successful in younger populations, but evidence specifically validating a simple bedside rule for intracranial bleeding after low-energy falls in older adults is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts and 6 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada (Not_yet_recruiting)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Not_yet_recruiting)
- Sinai Health System — Toronto, Ontario, Canada (Not_yet_recruiting)
- Centre Intégré Universitaire De Santé Et De Services Sociaux Du Nord-De-L'île-De-Montréal, — Montreal, Quebec, Canada (Not_yet_recruiting)
- CHU de Québec - Université Laval — Québec, Quebec, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Kerstin de Wit, MD — Queens University
- Study coordinator: Natasha Clayton, Clinical Trial Manager, CRA, RA
- Email: natasha.clayton@queensu.ca
- Phone: 416-566-3590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.