Intracranial BleedNCT07536906
Falls Validation Study
An observational study of Intracranial Bleed and Falls, run by Dr. Kerstin de Wit at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intracranial Bleed, Falls
- What is being tested?
- Clinical Decision Rule
- How many people
- 4,000 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 May 2026to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who present to the emergency department.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Canada6 sites, 6 recruiting
- Not yet recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 2X2
Natasha Clayton, 416-566-3590 ext. 76207, claytonn@hhsc.ca
Alim Pardhan, MD
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Natasha Clayton, 416-566-3590, natasha.clayton@queensu.ca
Isabelle Gray, MD
- Not yet recruiting
Centre Intégré Universitaire De Santé Et De Services Sociaux Du Nord-De-L'île-De-Montréal,
Montreal, Quebec, H3L 1K5
Justine Lessard, MD
- Not yet recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario
Gabriel Sandino-Gold, 613-798-5555 ext. 17709, gsandino@ohri.ca
Ian Stiell, MD
- Not yet recruiting
CHU de Québec - Université Laval
Québec, Quebec
Éric Mercier, MD, 418-649-0252 ext. 66024, eric.mercier@crchudequebec.ulaval.ca
Éric Mercier, MD
- Not yet recruiting
Sinai Health System
Toronto, Ontario, M5G 1X5
Cameron Thompson, 416-586-4800 ext. 3814, cameron.thompson@sinaihealth.ca
Catherine Varner, MD
United States1 site, 1 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02115
Shan Liu, MD
About this study
Official title: Validation of the Falls Decision Rule for Diagnosing Intracranial Bleeding in Older Adults After a Fall
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.
Read the detailed description
Traumatic intracranial bleeding is much more prevalent in older adults and has a much worse prognosis as compared to the younger population. Older adults are at risk of traumatic intracranial bleeding because there is loss of the elastic integrity of the cerebral bridging veins and brain atrophy, allowing rapid movements of the brain with trauma. The vast majority of traumatic intracranial bleeding diagnoses in older adults result from low-energy falls from standing or sitting.
In 2015, the Canadian Medical Association called for a national strategy for older adults that would include evidence-based hospital practices. In 2021-22, older adults accounted for about 25% of all Canadian emergency department visits, and older adults who had fallen account for over 3% of visits. This number continues to rise. A conservative estimation using 2022 Canadian Institute of Health Information data suggests there are at least 500,000 emergency department visits from older adults after a fall annually in Canada, yet there is little research evidence to guide testing for intracranial bleeding.
It is difficult for physicians to determine the risk of intracranial bleeding when an older patient has fallen. Diagnosing fall-related intracranial bleeding is an important part of the emergency department assessment. It is critical that older patients with intracranial bleeding are identified early so that they are provided with appropriate medical and neurosurgical care
To address the lack of evidence-based guidance specific to older adults who fall, the Falls Decision Rule was derived to guide the use of brain imaging.
Validation of the Falls Rules would improve image utilization for older adults who have fallen, meaning that intracranial bleeding would be diagnosed on the first emergency department visit. People with very low risk of intracranial bleeding would not need brain imaging which facilitates a faster discharge from the emergency department.
- Conditions
- Intracranial Bleed, Falls
- Being tested
- Clinical Decision Rule
- Keywords
- Falls, Intracranial Bleeding, Head CT, Computed Tomography, Clinical Decision Rule
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision RuleOther
The Falls Decision Rule will help guide emergency physicians when to obtain brain imaging and when brain imaging is not required.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Older adults who fall within 48 hours of emergency department visit Receives: Other: Clinical Decision Rule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (4)
Clinically Unimportant Intracranial Bleeding
Adjudicated intracranial bleeding within 30 days which does not meet our definition of clinically important.
Measured: 30 days
Delayed Intracranial Bleeding
Intracranial bleeding diagnosed after the emergency department visit until day 30
Measured: 30 days
Death
Death within 120 days of the index emergency department visit
Measured: 120 days
Recurrent Falls
Evidence that the patient fell at least 1 time after the index emergency department visit.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial BleedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Kerstin de Wit
- Sponsor type
- University, hospital or other
- Collaborators
- Network of Canadian Emergency Researchers (NCER)
- Responsible party
- Sponsor-investigator, Dr. Kerstin de Wit, Queen's University
- Investigators
- Kerstin de Wit, MD, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536906
- Sponsor's protocol ID
- 202409PJT
- Other IDs
- 527093-202409PJT
- Status last verified
- May 2026
- First submitted
- 11 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Falls Decision Rule for Diagnosing Intracranial Bleeding in Older Adults After a Fall
- ClinicalTrials.gov ID
- NCT07536906
- Acronym / sponsor ID
- 202409PJT
- Conditions
- Intracranial Bleed, Falls
- Keywords
- Falls, Intracranial Bleeding, Head CT, Computed Tomography, Clinical Decision Rule
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Dr. Kerstin de WitUniversity, hospital or other
- Collaborators
- Network of Canadian Emergency Researchers (NCER)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Traumatic intracranial bleeding is much more prevalent in older adults and has a much worse prognosis as compared to the younger population. Older adults are at risk of traumatic intracranial bleeding because there is loss of the elastic integrity of the cerebral bridging veins and brain atrophy, allowing rapid movements of the brain with trauma. The vast majority of traumatic intracranial bleeding diagnoses in older adults result from low-energy falls from standing or sitting.
In 2015, the Canadian Medical Association called for a national strategy for older adults that would include evidence-based hospital practices. In 2021-22, older adults accounted for about 25% of all Canadian emergency department visits, and older adults who had fallen account for over 3% of visits. This number continues to rise. A conservative estimation using 2022 Canadian Institute of Health Information data suggests there are at least 500,000 emergency department visits from older adults after a fall annually in Canada, yet there is little research evidence to guide testing for intracranial bleeding.
It is difficult for physicians to determine the risk of intracranial bleeding when an older patient has fallen. Diagnosing fall-related intracranial bleeding is an important part of the emergency department assessment. It is critical that older patients with intracranial bleeding are identified early so that they are provided with appropriate medical and neurosurgical care
To address the lack of evidence-based guidance specific to older adults who fall, the Falls Decision Rule was derived to guide the use of brain imaging.
Validation of the Falls Rules would improve image utilization for older adults who have fallen, meaning that intracranial bleeding would be diagnosed on the first emergency department visit. People with very low risk of intracranial bleeding would not need brain imaging which facilitates a faster discharge from the emergency department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Clinical Decision RuleOlder adults who fall within 48 hours of emergency department visit |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who present to the emergency department.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision RuleThe Falls Decision Rule will help guide emergency physicians when to obtain brain imaging and when brain imaging is not required. | Other | Cohort 1 |
Primary outcome
Clinically Important Intracranial Bleeding
Time frame: 30 days
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.
4 secondary outcomes
Clinically Unimportant Intracranial Bleeding
Time frame: 30 days
Delayed Intracranial Bleeding
Time frame: 30 days
Death
Time frame: 120 days
Recurrent Falls
Time frame: 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerstin de Wit, MD principal investigator
Queens University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Bleed and Falls, run by Dr. Kerstin de Wit at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Clayton, Clinical Trial Manager, CRA, RA (416-566-3590, natasha.clayton@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Important Intracranial Bleeding (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.