The Emergency Department Falls Study

NCT03870867 | Completed

• 1 other identifier: 467
• Study Type: observational
• Target: 1,753
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Fall; Head Injury Trauma; Intracranial Hemorrhages

Keywords

seniors; falls; imaging; emergency department; CT head; intracranial hemorrhages

Outcome Measures

Primary Outcomes (1)

• Intracranial Bleeding

  the incidence of intracranial bleeding (including subdural, subarachnoid, extradural, intracerebral and cerebral contusion) diagnosis in the following 6 weeks

  6 weeks

Secondary Outcomes (3)

• Proportion of immediate bleeds

  6 weeks

• Proportion of delayed bleeds

  6 weeks

• Proportion Eligible

  Duration of Recruitment

Study Arms (1)

Seniors who have fallen

Emergency department patients over the age of 65 who present to the emergency department after a fall.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Seniors who have fallen

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• + 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

You may not qualify if:

• Non-English speaking without an an adequate interpreter
• Falls with an other mechanism of injury
• Falls \> 48 hours before presentation

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Ciences

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Intracranial Hemorrhages; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Kerstin de Wit, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: March 12, 2019
• Study Start: December 14, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)