Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-09 @ 4:09 AM
Study NCT ID:
NCT03870867
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2018-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Emergency Department Falls Study
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Study Overview
Official Title:
Intracranial Bleeding and Emergency Physician CT Scanning in Seniors Who Have Fallen
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FALLS
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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: