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| ID | Type | Description | Link |
|---|---|---|---|
| 527093-202409PJT | Other Grant/Funding Number | Canadian Institutes of Health Research |
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| Name | Class |
|---|---|
| Network of Canadian Emergency Researchers (NCER) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Older adults who fall within 48 hours of emergency department visit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Unimportant Intracranial Bleeding | Adjudicated intracranial bleeding within 30 days which does not meet our definition of clinically important. | 30 days |
| Delayed Intracranial Bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who present to the emergency department.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natasha Clayton, Clinical Trial Manager, CRA, RA | Contact | 416-566-3590 | natasha.clayton@queensu.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kerstin de Wit, MD | Queens University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000081415 | Clinical Decision Rules |
| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| D008919 | Investigative Techniques |
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Intracranial bleeding diagnosed after the emergency department visit until day 30
| 30 days |
| Death | Death within 120 days of the index emergency department visit | 120 days |
| Recurrent Falls | Evidence that the patient fell at least 1 time after the index emergency department visit. | 120 days |
| Hamilton Health Sciences Corporation | Not yet recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| Kingston Health Sciences Centre | Recruiting | Kingston | Ontario | K7L 2V7 | Canada |
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| Ottawa Hospital Research Institute | Not yet recruiting | Ottawa | Ontario | Canada |
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| Sinai Health System | Not yet recruiting | Toronto | Ontario | M5G 1X5 | Canada |
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| Centre Intégré Universitaire De Santé Et De Services Sociaux Du Nord-De-L'île-De-Montréal, | Not yet recruiting | Montreal | Quebec | H3L 1K5 | Canada |
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| CHU de Québec - Université Laval | Not yet recruiting | Québec | Quebec | Canada |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |