Falls Validation Study

NCT07536906 | Not Yet Recruiting

• 2 other identifiers: 202409PJT527093-202409PJT
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 5

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. 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.

Conditions

Intracranial Bleed; Falls

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinically Important Intracranial Bleeding

  Intracranial 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.

  30 days

Secondary Outcomes (4)

• Clinically Unimportant Intracranial Bleeding

  30 days

• Delayed Intracranial Bleeding

  30 days

• Death

  120 days

• Recurrent Falls

  120 days

Study Arms (1)

Cohort 1

Older adults who fall within 48 hours of emergency department visit

Other: Clinical Decision Rule

Interventions

Clinical Decision Rule OTHER

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

Cohort 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the emergency department.

You may qualify if:

• age 65 or older who present to the emergency department within 48 hours of having a fall. Eligible patients will have fallen from standing, from a chair, toilet seat, or bed.

You may not qualify if:

• Patients will be excluded if they fall in any other circumstance, if they are transferred from another hospital after brain imaging, if they leave the emergency department prior to completion of their medical assessment, if they were previously enrolled, or if they live outside the hospital catchment area.

Sponsors & Collaborators

• Dr. Kerstin de Wit: lead
• Kingston Health Sciences Centre: collaborator
• Hamilton Health Sciences Corporation: collaborator
• Sinai Health System: collaborator
• CHU de Quebec-Universite Laval: collaborator
• Ottawa Hospital Research Institute: collaborator

Study Sites (5)

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L 2X2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Sinai Health System

Toronto, Ontario, M5G 1X5, Canada

Location

CHU de Québec - Université Laval

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Intracranial Hemorrhages

Interventions

Clinical Decision Rules

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Decision Support Techniques; Investigative Techniques

Study Officials

• Kerstin de Wit, MD

  Queens University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Clayton, Clinical Trial Manager, CRA, RA

CONTACT

416-566-3590; natasha.clayton@queensu.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): December 30, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)