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临床试验/NCT06780722
NCT06780722招募中不适用

Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure. Prospective Observational Multicenter Study

Nantes University Hospital12 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
12
主要终点
PaO2 level

研究概览

简要总结

Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

详细描述

Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • •FOR THE DONORS :
  • •Inclusion Criteria :
  • •Patient over 18 years of age
  • •Organ donation procedure initiated in accordance with the legislation and procedures in force in France for the Maastricht III category
  • •No opposition formulated by the relative to the patient's participation in the study

排除标准

  • •Patient registered on the national register of refusals or living refusal of donation
  • •Pregnant or breast-feeding women
  • •Patients under guardianship, curatorship or legal protection
  • •Medical contraindication to organ donation according to the recommendations of the Agence de Biomédecine currently in force in France
  • •FOR THE RECEIVER
  • •Inclusion Criteria :
  • •No opposition to the collection of data concerning him/her
  • •Patient over 18 at pre-transplant consultation
  • •Patient who has received an organ from a donor participating in the HEPHAISTOS protocol
  • •Exclusion Criteria :
  • •- Patients under guardianship, curatorship or legal protection

结局指标

主要结局

PaO2 level

时间窗: 24 hours

PaO2 level and its 95% confidence interval in the event of circulatory cardiac arrest, defined as a pulse pressure below 5 mmHg, during a Maastricht III procedure.

次要结局

  • Spo2 Level(24 hours)
  • Correlation between the rate of delayed recovery of renal function in the recipient and the presence of hypoxemia at the time of cardiocirculatory arrest in the donor.(7 days)
  • Time between occurrence of first episode of pulsed oxygen saturation below 95% and onset of cardiocirculatory arrest(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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