FallNCT03745755
Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen
An observational study of Fall and Intracranial Bleed, run by McMaster University at 1 site in Canada.
Trial summary
Falls are the leading cause of traumatic death in the elderly with head injury causing half of these deaths. Each year, one in three adults over the age of 65 (seniors) fall, and half of these seniors seek treatment at a hospital emergency department (ED). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall, Intracranial Bleed
- How many people
- 4,308 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2019to 20 Jul 2023
- 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
- No healthy volunteers
- Older adult
Study population: ED patients aged over 65 years who present to the ED within 48 hours of having a fall. Eligibility is determined by having fallen on level ground (either inside or outside), off a chair or toilet seat or off a bed. Patients are included regardless of whether they hit their head.
Who may be able to join
- 65+ years old
- Fall within 48 hours of emergency department visit (regardless of presenting complaint)
Who cannot join
- Repeat event/visit (already enrolled in the study)
- Transferred from another hospital
- Lives outside of hospital catchment area
- Major trauma (e.g. fall from steps, fall from height, motor vehicle accident, struck by a vehicle, recreational accident)
- Left emergency department prior to completion of assessment (left against medical advice)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen (the Falls Multicentre Study)
Falls are the leading cause of traumatic death in the elderly with head injury causing half of these deaths. Each year, one in three adults over the age of 65 (seniors) fall, and half of these seniors seek treatment at a hospital emergency department (ED). There is a major evidence gap in the study of brain injury diagnosis in seniors, which is problematic for emergency physicians since the number of fall-associated head injuries is rising. ED diagnostic tools for risk stratification of these patients do not exist. The investigators will derive a novel ED clinical decision rule for detecting traumatic intracranial bleeding which will standardize the approach to head CT scans. Once validated, the investigators will optimize patient care by ensuring that intracranial bleeding is identified early. By reducing the use of head CT, this decision rule will lead to health care savings and streamlined, patient-centered ED care.
Read the detailed description
This study is designed to develop a unique clinical decision rule for ED physicians evaluating senior patients who have fallen. Clinical decision rules are a common method for standardizing diagnostic decision-making and minimizing misdiagnosis in the ED. Each patient will be assessed at their index ED visit by an emergency physician who will record history and examination findings. The primary outcome will be clinically important intracranial bleeding diagnosed with 42 days. Patients who return to the ED within 42 days with new confusion, headache, loss of balance, repeat falls, change in behaviour, reduced Glasgow Coma Scale score or other neurological symptoms will also undergo head CT. All intracranial bleeding events will be adjudicated independently.
- Conditions
- Fall, Intracranial Bleed
- Keywords
- elderly, clinical decision rule, emergency department, CT scan, bleeding
- Medical subject headings
- Intracranial Hemorrhages, Emergencies, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically important intracranial bleeding
Number of patients with bleeding within the cranial vault (including subdural, intracerebral, intraventricular, subarachnoid, epidural blood and cerebral contusion) which requires medical or surgical treatment.
Measured: Within 42 days of the index emergency department presentation.
Secondary outcomes (4)
Neurosurgical intervention
Number of patients with intracranial bleeding who undergo neurosurgical intervention.
Measured: Within 90 days
Intensive care admission
Number of patients with intracranial bleeding who are admitted to the intensive care unit.
Measured: Within 90 days
Hospital length of stay
Duration of hospitalization among patients with intracranial bleeding.
Measured: Within 90 days
In-hospital death
Number of patients with intracranial bleeding who die in hospital.
Measured: Within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start30 Jan 2019
- Primary completion15 Nov 2020
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- 4,308 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Kerstin de Wit, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745755
- Sponsor's protocol ID
- Falls_MC_5304
- Status last verified
- Jul 2023
- First submitted
- 15 Nov 2018
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Wit K, Mercuri M, Clayton N, Mercier E, Morris J, Jeanmonod R, Eagles D, Varner C, Barbic D, Buchanan IM, Ali M, Kagoma YK, Shoamanesh A, Engels P, Sharma S, Worster A, McLeod S, Emond M, Stiell I, Papaioannou A, Parpia S; Network of Canadian Emergency Researchers. Derivation of the Falls Decision Rule to exclude intracranial bleeding without head CT in older adults who have fallen. CMAJ. 2023 Dec 3;195(47):E1614-E1621. doi: 10.1503/cmaj.230634.
PubMed 38049159de Wit K, Mercuri M, Clayton N, Worster A, Mercier E, Emond M, Varner C, McLeod SL, Eagles D, Stiell I, Barbic D, Morris J, Jeanmonod R, Kagoma Y, Shoamanesh A, Engels PT, Sharma S, Kearon C, Papaioannou A, Parpia S; Network of Canadian Emergency Researchers. Which older emergency patients are at risk of intracranial bleeding after a fall? A protocol to derive a clinical decision rule for the emergency department. BMJ Open. 2021 Jul 2;11(7):e044800. doi: 10.1136/bmjopen-2020-044800.
PubMed 34215600
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen (the Falls Multicentre Study)
- ClinicalTrials.gov ID
- NCT03745755
- Acronym / sponsor ID
- Falls_MC_5304
- Conditions
- Fall, Intracranial Bleed
- Keywords
- elderly, clinical decision rule, emergency department, CT scan, bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,308 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 19 Nov 2018 (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.
Falls are the leading cause of traumatic death in the elderly with head injury causing half of these deaths. Each year, one in three adults over the age of 65 (seniors) fall, and half of these seniors seek treatment at a hospital emergency department (ED). There is a major evidence gap in the study of brain injury diagnosis in seniors, which is problematic for emergency physicians since the number of fall-associated head injuries is rising. ED diagnostic tools for risk stratification of these patients do not exist. The investigators will derive a novel ED clinical decision rule for detecting traumatic intracranial bleeding which will standardize the approach to head CT scans. Once validated, the investigators will optimize patient care by ensuring that intracranial bleeding is identified early. By reducing the use of head CT, this decision rule will lead to health care savings and streamlined, patient-centered ED care.
Detailed description
This study is designed to develop a unique clinical decision rule for ED physicians evaluating senior patients who have fallen. Clinical decision rules are a common method for standardizing diagnostic decision-making and minimizing misdiagnosis in the ED. Each patient will be assessed at their index ED visit by an emergency physician who will record history and examination findings. The primary outcome will be clinically important intracranial bleeding diagnosed with 42 days. Patients who return to the ED within 42 days with new confusion, headache, loss of balance, repeat falls, change in behaviour, reduced Glasgow Coma Scale score or other neurological symptoms will also undergo head CT. All intracranial bleeding events will be adjudicated independently.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- ED patients aged over 65 years who present to the ED within 48 hours of having a fall. Eligibility is determined by having fallen on level ground (either inside or outside), off a chair or toilet seat or off a bed. Patients are included regardless of whether they hit their head.
Key inclusion criteria (2 listed)
- 65+ years old
- Fall within 48 hours of emergency department visit (regardless of presenting complaint)
Key exclusion criteria (5 listed)
- Repeat event/visit (already enrolled in the study)
- Transferred from another hospital
- Lives outside of hospital catchment area
- Major trauma (e.g. fall from steps, fall from height, motor vehicle accident, struck by a vehicle, recreational accident)
- Left emergency department prior to completion of assessment (left against medical advice)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically important intracranial bleeding
Time frame: Within 42 days of the index emergency department presentation.
Number of patients with bleeding within the cranial vault (including subdural, intracerebral, intraventricular, subarachnoid, epidural blood and cerebral contusion) which requires medical or surgical treatment.
4 secondary outcomes
Neurosurgical intervention
Time frame: Within 90 days
Intensive care admission
Time frame: Within 90 days
Hospital length of stay
Time frame: Within 90 days
In-hospital death
Time frame: Within 90 days
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 25 Jul 2023.
- Derived from this study: PubMed 38049159de Wit K, Mercuri M, Clayton N, Mercier E, Morris J, Jeanmonod R, Eagles D, Varner C, Barbic D, Buchanan IM, Ali M, Kagoma YK, Shoamanesh A, Engels P, Sharma S, Worster A, McLeod S, Emond M, Stiell I, Papaioannou A, Parpia S; Network of Canadian Emergency Researchers. Derivation of the Falls Decision Rule to exclude intracranial bleeding without head CT in older adults who have fallen. CMAJ. 2023 Dec 3;195(47):E1614-E1621. doi: 10.1503/cmaj.230634.
- Derived from this study: PubMed 34215600de Wit K, Mercuri M, Clayton N, Worster A, Mercier E, Emond M, Varner C, McLeod SL, Eagles D, Stiell I, Barbic D, Morris J, Jeanmonod R, Kagoma Y, Shoamanesh A, Engels PT, Sharma S, Kearon C, Papaioannou A, Parpia S; Network of Canadian Emergency Researchers. Which older emergency patients are at risk of intracranial bleeding after a fall? A protocol to derive a clinical decision rule for the emergency department. BMJ Open. 2021 Jul 2;11(7):e044800. doi: 10.1136/bmjopen-2020-044800.
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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
McMaster University
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 Intracranial Bleed, run by McMaster University 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 5 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 25 Jul 2023. 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?
Clinically important intracranial bleeding (time frame: Within 42 days of the index emergency department presentation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03745755, which also lists 2 linked publications.
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 25 Jul 2023.