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

NCT03745755 | Completed

• 1 other identifier: Falls_MC_5304
• Study Type: observational
• Target: 4,308
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall; Intracranial Bleed

Keywords

elderly; clinical decision rule; emergency department; CT scan; bleeding

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 42 days of the index emergency department presentation.

Secondary Outcomes (4)

• Neurosurgical intervention

  Within 90 days

• Intensive care admission

  Within 90 days

• Hospital length of stay

  Within 90 days

• In-hospital death

  Within 90 days

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

Related Publications (2)

• 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.

  PMID: 38049159 DERIVED

• de 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.

  PMID: 34215600 DERIVED

MeSH Terms

Conditions

Intracranial Hemorrhages; Emergencies; Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Kerstin de Wit, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: January 30, 2019
• Primary Completion: November 15, 2020
• Study Completion: July 20, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

CA (1)