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临床试验/NCT03870867
NCT03870867已完成不适用

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

Hamilton Health Sciences Corporation1 个研究点 分布在 1 个国家目标入组 1,753 人开始时间: 2015年12月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,753
试验地点
1
主要终点
Intracranial Bleeding

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Intracranial Bleeding

时间窗: 6 weeks

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

次要结局

  • Proportion of immediate bleeds(6 weeks)
  • Proportion Eligible(Duration of Recruitment)
  • Proportion of delayed bleeds(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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