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Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen

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ClinicalTrials.gov Identifier: NCT03745755
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

Brief 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). 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.

Condition or disease
Fall Intracranial Bleed

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 GCS or other neurological symptoms will also undergo head CT. All intracranial bleeding events will be adjudicated independently.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen (the Falls Multicentre Study)
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Neurosurgical intervention [ Time Frame: Within 90 days ]
    Number of patients with intracranial bleeding who undergo neurosurgical intervention.

  2. Intensive care admission [ Time Frame: Within 90 days ]
    Number of patients with intracranial bleeding who are admitted to the intensive care unit.

  3. Hospital length of stay [ Time Frame: Within 90 days ]
    Duration of hospitalization among patients with intracranial bleeding.

  4. In-hospital death [ Time Frame: Within 90 days ]
    Number of patients with intracranial bleeding who die in hospital.

  5. Recurrence of bleed within 90 days [ Time Frame: Within 90 days ]
    The number of patients who have more than one intracranial bleed within 90 days of the index ED visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 65+ years old
  • Fall within 48 hours of emergency department visit (regardless of presenting complaint)

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745755


Contacts
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Contact: Kerstin de Wit, MD 289-208-4090 dewitk@mcmaster.ca
Contact: Natasha Clayton, CRA 905-521-2100 ext 44832 clayton@mcmaster.ca

Locations
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Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada
Contact: Natasha Clayton, CRA         
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Kerstin de Wit, MD McMaster University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03745755     History of Changes
Other Study ID Numbers: Falls_MC_5304
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
elderly
clinical decision rule
emergency department
CT scan
bleeding
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Emergencies
Disease Attributes
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhage