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临床试验/NCT04397588
NCT04397588已完成不适用

Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study

Rennes University Hospital88 个研究点 分布在 1 个国家目标入组 761 人开始时间: 2020年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
761
试验地点
88
主要终点
Hospital mortality

研究概览

简要总结

The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.

详细描述

The main objective of this study is to evaluate the hospital survival of COVID-19 patients supported by venovenous or venoarterial ECMO in a multicenter registry.

The secondary objectives are to describe the characteristics of COVID-19 patients who have received ECMO support, to identify the risk factors associated with hospital mortality, to analyze the outcomes after ECMO weaning including survival at day 28 and day 90, and to analyze the utility of a circulatory support mobile unit in a severe pandemic

Inclusions are both prospective and retrospective in order to collect data over the whole pandemic

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All COVID-19 patients, adults or children,
  • Tested positive by RT-PCR for SARS-CoV2 (nasopharyngeal swabs, sputum, endotracheal aspiration, bronchoalveolar lavage or stool sample) and / or with a diagnosis made on chest CT findings,
  • Supported by venovenous or venoarterial ECMO

排除标准

  • Temporary legally protected Adults over a set period or waiting for protection supervision, guardianship
  • Patients or proxies who express their opposition to study participation

结局指标

主要结局

Hospital mortality

时间窗: up to 90 days

Hospital mortality

次要结局

  • Mortality Day 90(Day 90)
  • Ventilator-free days(Day 28)
  • Mortality Day 28(Day 28)
  • Intensive care unit-free days(Day 28)
  • Hospital-free days(Day 28)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (88)

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