Health TrialsbyHealthPanel

Falls Validation Study

ConditionsIntracranial BleedFalls
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorDr. Kerstin de Wit

About this trial

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.

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 was created. This decision rule will be checked to see if it works well in guiding who needs a brain scan.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients who present to the emergency department.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clinical Decision Rule

    Other intervention

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

Treatment groups

4,000 Participants
are divided into 1 treatment group
Group A: Cohort 11 intervention

Trial outcomes

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.

Time frame
30 days

Secondary outcomes

1

Clinically Unimportant Intracranial Bleeding

Adjudicated intracranial bleeding within 30 days which does not meet our definition of clinically important.

Time frame
30 days
2

Delayed Intracranial Bleeding

Intracranial bleeding diagnosed after the emergency department visit until day 30

Time frame
30 days
3

Death

Death within 120 days of the index emergency department visit

Time frame
120 days
4

Recurrent Falls

Evidence that the patient fell at least 1 time after the index emergency department visit.

Time frame
120 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Kerstin de Wit

Lead sponsor

Queen's University

Sponsor institution

Network of Canadian Emergency Researchers (NCER)

Collaborator

Source ClinicalTrials.gov
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