An observational study in Intracranial Bleed and Falls, sponsored by Dr. Kerstin de Wit. Recruiting at 7 sites in 2 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Dr. Kerstin de Wit · Observational
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.
199 studies on the registry are indexed under Intracranial Hemorrhages; 64 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 240 across 87 observational studies indexed under Intracranial Hemorrhages.
Browse Intracranial Hemorrhages studies →Dr. Kerstin de Wit is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who present to the emergency department.
Exclusion Criteria:
Older adults who fall within 48 hours of emergency department visit
Other: Clinical Decision Rule
The Falls Decision Rule will help guide emergency physicians when to obtain brain imaging and when brain imaging is not required.
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
Clinically Unimportant Intracranial Bleeding
Adjudicated intracranial bleeding within 30 days which does not meet our definition of clinically important.
Time frame: 30 days
Delayed Intracranial Bleeding
Intracranial bleeding diagnosed after the emergency department visit until day 30
Time frame: 30 days
Death
Death within 120 days of the index emergency department visit
Time frame: 120 days
Recurrent Falls
Evidence that the patient fell at least 1 time after the index emergency department visit.
Time frame: 120 days
Plan to share: No
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Dr. Kerstin de Wit