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临床试验/NCT07536906
NCT07536906招募中不适用

Validation of the Falls Decision Rule for Diagnosing Intracranial Bleeding in Older Adults After a Fall

Dr. Kerstin de Wit7 个研究点 分布在 2 个国家目标入组 4,000 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
4,000
试验地点
7
主要终点
Clinically Important Intracranial Bleeding

研究概览

简要总结

Each year, one in three adults over the age of 65 has a fall. These falls lead to half a million Canadian emergency department patient visits annually and falls in older adults account for more than 3% of all emergency department visits.

A rapid, simple bedside test (known as a decision rule) to guide emergency physicians on when older adults should have a brain scan to diagnose traumatic brain bleeding was created. This decision rule will be checked to see if it works well in guiding who needs a brain scan.

详细描述

Traumatic intracranial bleeding is much more prevalent in older adults and has a much worse prognosis as compared to the younger population. Older adults are at risk of traumatic intracranial bleeding because there is loss of the elastic integrity of the cerebral bridging veins and brain atrophy, allowing rapid movements of the brain with trauma. The vast majority of traumatic intracranial bleeding diagnoses in older adults result from low-energy falls from standing or sitting.

In 2015, the Canadian Medical Association called for a national strategy for older adults that would include evidence-based hospital practices. In 2021-22, older adults accounted for about 25% of all Canadian emergency department visits, and older adults who had fallen account for over 3% of visits. This number continues to rise. A conservative estimation using 2022 Canadian Institute of Health Information data suggests there are at least 500,000 emergency department visits from older adults after a fall annually in Canada, yet there is little research evidence to guide testing for intracranial bleeding.

It is difficult for physicians to determine the risk of intracranial bleeding when an older patient has fallen. Diagnosing fall-related intracranial bleeding is an important part of the emergency department assessment. It is critical that older patients with intracranial bleeding are identified early so that they are provided with appropriate medical and neurosurgical care

To address the lack of evidence-based guidance specific to older adults who fall, the Falls Decision Rule was derived to guide the use of brain imaging.

Validation of the Falls Rules would improve image utilization for older adults who have fallen, meaning that intracranial bleeding would be diagnosed on the first emergency department visit. People with very low risk of intracranial bleeding would not need brain imaging which facilitates a faster discharge from the emergency department.

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

  • Age 65 or older
  • Present to the emergency department within 48 hours of having a fall
  • Fall from standing, from a chair, toilet seat, or bed

排除标准

  • Transferred from another hospital organization after brain imaging
  • Leave the emergency department prior to completion of their medical assessment
  • Previously enrolled
  • Lives outside the hospital catchment area

研究组 & 干预措施

Cohort 1

Older adults who fall within 48 hours of emergency department visit

干预措施: Clinical Decision Rule (Other)

结局指标

主要结局

Clinically Important Intracranial Bleeding

时间窗: 30 days

Intracranial bleeding diagnosed at the index emergency department visit or within 30 days. Clinically important intracranial bleeding is defined as bleeding within the cranial vault (including subdural, intracerebral, intraventricular, subarachnoid, epidural blood, and cerebral contusion), which subsequently requires medical or surgical intervention for the bleed or causes death.

次要结局

  • Death(120 days)
  • Clinically Unimportant Intracranial Bleeding(30 days)
  • Delayed Intracranial Bleeding(30 days)
  • Recurrent Falls(120 days)

研究者

发起方
Dr. Kerstin de Wit
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Kerstin de Wit

Professor

Queen's University

研究点 (7)

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