The Emergency Department Falls Study

Fall Clinical Trial

— FALLS  

Official title:

Intracranial Bleeding and Emergency Physician CT Scanning in Seniors Who Have Fallen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870867
• Other study ID #: 467
• Status: Completed
• Start date: December 14, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2019
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1753
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Non-English speaking without an an adequate interpreter

• Falls with an other mechanism of injury

• Falls > 48 hours before presentation

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Emergencies
• Fall
• Head Injury Trauma
• Hemorrhage
• Intracranial Hemorrhages

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Canada	Hamilton Health Ciences	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial Bleeding	the incidence of intracranial bleeding (including subdural, subarachnoid, extradural, intracerebral and cerebral contusion) diagnosis in the following 6 weeks	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	Proportion Eligible	Proportion of eligible patients identified, recruited and followed up	Duration of Recruitment