Actively Recruiting
Validation of the Falls Decision Rule for Diagnosing Intracranial Bleeding in Older Adults After a Fall
Led by Dr. Kerstin de Wit · Updated on 2026-05-27
4000
Participants Needed
7
Research Sites
87 weeks
Total Duration
On this page
Sponsors
D
Dr. Kerstin de Wit
Lead Sponsor
N
Network of Canadian Emergency Researchers (NCER)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Falls are a common and serious problem among adults aged 65 and older, leading to many emergency department visits and significant health risks such as traumatic brain bleeding. This research investigates a simple bedside decision rule designed to help emergency doctors determine when brain scans are needed for older adults after a fall. The goal is to improve diagnosis and care by identifying those at risk more accurately and efficiently. The study uses the Falls Decision Rule, which guides emergency physicians on whether to perform brain imaging for older adults who have experienced a fall within 48 hours. This observational study tracks patients presenting after low-energy falls, such as from standing, sitting, or a bed, to validate how well this decision rule works in clinical practice. The study does not involve any experimental treatments but observes the use of this clinical tool. Participants will be monitored for outcomes including important and unimportant intracranial bleeding within 30 days, delayed bleeding, death, and repeat falls up to 120 days. Data will be collected during their emergency department visit and through follow-up to understand the decision rule’s effectiveness in guiding imaging use and patient outcomes. The total duration of participation varies depending on individual follow-ups, with primary results assessed at 30 days after the fall event.
CONDITIONS
Brief Title
Falls Validation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during the emergency department visit
Duration - 48 hours
Participants undergo assessment using the Falls Decision Rule to determine the need for brain imaging after a fall.
1 visit (in-person) in the emergency department
Duration - Up to 120 days
Participants are monitored for clinically important and unimportant intracranial bleeding, delayed bleeding, death, and recurrent falls.
Follow-up assessments up to 120 days after the emergency department visit
Trial Site Locations
Total: 7 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8L 2X2
Not Yet Recruiting
3
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
4
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Not Yet Recruiting
5
Sinai Health System
Toronto, Ontario, Canada, M5G 1X5
Not Yet Recruiting
6
Centre Intégré Universitaire De Santé Et De Services Sociaux Du Nord-De-L'île-De-Montréal,
Montreal, Quebec, Canada, H3L 1K5
Not Yet Recruiting
7
CHU de Québec - Université Laval
Québec, Quebec, Canada
Not Yet Recruiting
Research Team
N
Natasha Clayton, Clinical Trial Manager, CRA, RA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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