FallFALLSNCT03870867
The Emergency Department Falls Study
An observational study of Fall and Head Injury Trauma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
This is a pilot study to evaluate clinical predictors of intracranial bleeding in elderly patients who present to the emergency department (ED) after a fall. The aim is to assess feasibility and rate of patient recruitment, patient follow up, and to establish a point estimate for the incidence of intracranial bleeding… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall, Head Injury Trauma, Intracranial Hemorrhages
- How many people
- 1,753 participants
- Where
- 1 siteCanada
- Study dates
- 14 Dec 2015to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Older adult
Study population: Patients over the age of 65 who present to the emergency departments of the Hamilton General or Juravinski Hospitals following a fall are eligible for recruitment
Who may be able to join
- 65+ years
- Presenting to the emergency department with fall on level ground, from a bed, from a chair, from the toilet seat or down steps 1 or 2 steps, within the last 48 hours
Who cannot join
- Non-English speaking without an an adequate interpreter
- Falls with an other mechanism of injury
- Falls > 48 hours before presentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracranial Bleeding and Emergency Physician CT Scanning in Seniors Who Have Fallen
This is a pilot study to evaluate clinical predictors of intracranial bleeding in elderly patients who present to the emergency department (ED) after a fall. The aim is to assess feasibility and rate of patient recruitment, patient follow up, and to establish a point estimate for the incidence of intracranial bleeding in the investigator's population.
Currently there are no guidelines for ED physicians to assess the pretest probability of intracranial bleed in these patients, and no safe way to exclude a bleed without CT.
Read the detailed description
Seniors account for 15% of the Canadian population. The proportion will greatly increase over the next few years. Elderly people attend the ED more often than younger people, and they often come to the ED after a fall at home or outside. Falling is associated with head injuries, which cause half of all the deaths from falling.
Head injuries are diagnosed with CT scans. In the ED, it can be difficult for the physician to know when to perform a CT scan of the head. It can be hard to know if the elderly person hit their head, and often times, people with bleeding in the head can have a normal examination. The Investigators think that the overall risk of bleeding in the head in elderly who fall is between 3 and 10%. If emergency physicians scanned every senior who fell, only a few would show bleeding, the scanning department would be overwhelmed, there would be increased costs for the hospital and longer delays for patients. It is important for physicians to diagnose a serious head injury as there are lifesaving treatments that can be given.
The Investigators plan to develop a decision rule for emergency physicians that would inform them which patients should have a CT scan of the head and which patients can have a serious head injury safely ruled out without a CT.
The Investigators propose to identify and recruit patients over the age of 65 who come to the Hamilton General or Juravinski Emergency departments after falling. Patients and their caregivers will be consented for a telephone follow-up call after 6 weeks. Data collected will include patient characteristics, general health, and blood test results which might be predictors of a serious head injury.
The Investigators will develop a tool to help emergency physicians to order a CT scan on the right patients.
- Conditions
- Fall, Head Injury Trauma, Intracranial Hemorrhages
- Being tested
- No intervention
- Keywords
- seniors, falls, imaging, emergency department, CT head, intracranial hemorrhages
- Medical subject headings
- Intracranial Hemorrhages, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Seniors who have fallen | Emergency department patients over the age of 65 who present to the emergency department after a fall. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Bleeding
the incidence of intracranial bleeding (including subdural, subarachnoid, extradural, intracerebral and cerebral contusion) diagnosis in the following 6 weeks
Measured: 6 weeks
Secondary outcomes (3)
Proportion of immediate bleeds
Intracranial bleeding categorized as 'immediate' and 'delayed', neurosurgical intervention for intracranial bleeding, length of stay in hospital and all cause mortality at 6 weeks.
Measured: 6 weeks
Proportion of delayed bleeds
Intracranial bleeding categorized as 'immediate' and 'delayed', neurosurgical intervention for intracranial bleeding, length of stay in hospital and all cause mortality at 6 weeks.
Measured: 6 weeks
Proportion Eligible
Proportion of eligible patients identified, recruited and followed up
Measured: Duration of Recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start14 Dec 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies 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
- 1,753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerstin de Wit, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870867
- Sponsor's protocol ID
- 467
- Acronym
- FALLS
- Status last verified
- Mar 2019
- First submitted
- 6 Apr 2018
- Last updated
- 12 Mar 2019
- 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 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Bleeding and Emergency Physician CT Scanning in Seniors Who Have Fallen
- ClinicalTrials.gov ID
- NCT03870867
- Acronym / sponsor ID
- FALLS / 467
- Conditions
- Fall, Head Injury Trauma, Intracranial Hemorrhages
- Keywords
- seniors, falls, imaging, emergency department, CT head, intracranial hemorrhages
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,753 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 14 Dec 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 12 Mar 2019 (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.
This is a pilot study to evaluate clinical predictors of intracranial bleeding in elderly patients who present to the emergency department (ED) after a fall. The aim is to assess feasibility and rate of patient recruitment, patient follow up, and to establish a point estimate for the incidence of intracranial bleeding in the investigator's population.
Currently there are no guidelines for ED physicians to assess the pretest probability of intracranial bleed in these patients, and no safe way to exclude a bleed without CT.
Detailed description
Seniors account for 15% of the Canadian population. The proportion will greatly increase over the next few years. Elderly people attend the ED more often than younger people, and they often come to the ED after a fall at home or outside. Falling is associated with head injuries, which cause half of all the deaths from falling.
Head injuries are diagnosed with CT scans. In the ED, it can be difficult for the physician to know when to perform a CT scan of the head. It can be hard to know if the elderly person hit their head, and often times, people with bleeding in the head can have a normal examination. The Investigators think that the overall risk of bleeding in the head in elderly who fall is between 3 and 10%. If emergency physicians scanned every senior who fell, only a few would show bleeding, the scanning department would be overwhelmed, there would be increased costs for the hospital and longer delays for patients. It is important for physicians to diagnose a serious head injury as there are lifesaving treatments that can be given.
The Investigators plan to develop a decision rule for emergency physicians that would inform them which patients should have a CT scan of the head and which patients can have a serious head injury safely ruled out without a CT.
The Investigators propose to identify and recruit patients over the age of 65 who come to the Hamilton General or Juravinski Emergency departments after falling. Patients and their caregivers will be consented for a telephone follow-up call after 6 weeks. Data collected will include patient characteristics, general health, and blood test results which might be predictors of a serious head injury.
The Investigators will develop a tool to help emergency physicians to order a CT scan on the right patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seniors who have fallen | – | Other: No interventionEmergency department patients over the age of 65 who present to the emergency department after a fall. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients over the age of 65 who present to the emergency departments of the Hamilton General or Juravinski Hospitals following a fall are eligible for recruitment
Key inclusion criteria (2 listed)
- 65+ years
- Presenting to the emergency department with fall on level ground, from a bed, from a chair, from the toilet seat or down steps 1 or 2 steps, within the last 48 hours
Key exclusion criteria (3 listed)
- Non-English speaking without an an adequate interpreter
- Falls with an other mechanism of injury
- Falls > 48 hours before presentation
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 |
|---|---|---|
| No interventionNo intervention | Other | Seniors who have fallen |
Primary outcome
Intracranial Bleeding
Time frame: 6 weeks
the incidence of intracranial bleeding (including subdural, subarachnoid, extradural, intracerebral and cerebral contusion) diagnosis in the following 6 weeks
3 secondary outcomes
Proportion of immediate bleeds
Time frame: 6 weeks
Proportion of delayed bleeds
Time frame: 6 weeks
Proportion Eligible
Time frame: Duration of Recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- 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. This study is not recruiting at the moment.
Kerstin de Wit, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fall and Head Injury Trauma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Bleeding (time frame: 6 weeks). 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 12 Mar 2019.