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临床试验/NCT04044924
NCT04044924已完成不适用

Geriatric Head Trauma Short Term Outcomes Project

Florida Atlantic University2 个研究点 分布在 1 个国家目标入组 5,387 人开始时间: 2019年8月15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
5,387
试验地点
2
主要终点
Number of Participants with Hospitalizations at 14 days

研究概览

简要总结

This prospective observational study will examine the incidence of intracranial hemorrhage. The investigators will compare patients on anticoagulant and/or antiplatelet therapy with head trauma compared to patients not on these medications. While many studies have sought to quantify the incidence of intracranial hemorrhage in these patients, there is considerable controversy regarding their care and what to do after an initial negative head CT in anticoagulated geriatric patients who have experienced head trauma.

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

  • Patients seen in the emergency department for head trauma

排除标准

  • Penetrating head trauma

结局指标

主要结局

Number of Participants with Hospitalizations at 14 days

时间窗: 14 days

If patient is admitted for any reason after initial ED visit

Number of Participants with Primary Intracranial Hemorrhage

时间窗: initial hospital visit

ICH on initial head CT scan

Number of Participants with Delayed Intracranial Hemorrhage

时间窗: 14 days

ICH on repeat CT scan

Mortality of Participants

时间窗: 60 days

Death of patient from any cause at primary visit or up to 60 days from follow-up

Number of Participants with 14 Day ED Returns

时间窗: 14 days

Return visit to ED within 2 weeks

次要结局

  • New Symptoms(60 days)
  • New interventions since fall(60 days)
  • Life alterations(60 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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