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临床试验/NCT01214018
NCT01214018终止不适用

Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors: Comparison With the Nearest-relatives of Brain-dead Patients Who Were Not Organ Donors for Medical or Legal Reasons, or Because of Donation Opposition

Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2011年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
91
试验地点
4
主要终点
Proportion of participants with an IES score > 37

研究概览

简要总结

The goal is to compare post tramautic stress between the nearest relatives of brain-dead patients who are organ donor to those of brain-dead patients who are not organ donors for medical, legal or opposition reasons.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased

排除标准

  • refusal to participate
  • does not speak French
  • deaf/mute
  • adult, but under guardianship

结局指标

主要结局

Proportion of participants with an IES score > 37

时间窗: 2 hours

The IES score follows Azoulay et al (2005). Am J Respir Crit Care Med. 171: 987-94. IES = Impact of Event Scale - revised, ranging from 0 to 88, with 88 being the greatest risk for post-traumatic stress

次要结局

  • The IES score(2 hours)
  • Hospital Depression and Anxiety Score (HDAS)(2 hours)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (4)

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