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临床试验/NCT03348072
NCT03348072已完成不适用

Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses

Pierre Wauthy1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
93
试验地点
1
主要终点
Survival rate

研究概览

简要总结

This is a comparative study on the survival and long-term quality of life of Jehovah's witnesses having undergone a cardiac surgery and having refused blood transfusions for religious reasons. This group will be compared with two other groups having no restrictions on this subject.

The purpose of the study is to evaluate the impact of this decision on survival and postoperative quality of life, in the long term.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • •Cardiac surgery with extra corporeal blood circulation
  • •Informed consent given

排除标准

  • •Dementia (must be able to answer the questionnaire)
  • •Control group: refusal of blood transfusions

结局指标

主要结局

Survival rate

时间窗: Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed

Survival rate

Quality of life (score)

时间窗: Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed

Score computed with the "MacNew Heart Disease health-related quality of life instrument".The MacNew is a valuable tool for assessing and evaluating health related quality of life in heart disease patients. It consists of 27 questions, falling into 3 possible domains: physicial limitation capacity (13 questions), emotional domain (14 questions), social domain (13 questions), symptom related (5 questions). The time frame for the MacNew is the previous two weeks. Scoring of the MacNew is simple: one score in each domain and a global score (4 scores). The maximum possible score in any domain is 7 \[high HRQL\] and the minimum is 1 \[poor HRQL\].The global score is calculated as the average over all scored items unless one of the domains is completely missing.

次要结局

未报告次要终点

研究者

发起方
Pierre Wauthy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre Wauthy

Head of clinic

Brugmann University Hospital

研究点 (1)

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