Actively Recruiting

Age: 65Years +
All Genders
ID07536906

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

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during the emergency department visit

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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