Extracorporeal Membrane Oxygenation (ECMO) and Coronavirus Disease (COVID) 19

• Conditions: ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2; Acute Refractory Heart Failure Related to SARS-CoV 2

• Registration Number: NCT04397588
• Lead Sponsor: Rennes University Hospital

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2020-04-21
• Status Verified: 2020-05
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Last Update Submitted: 2020-08-28
• Last Update Posted: 2020-08-31
• Primary Completion: 2020-10-21
• Study Completion: 2020-10-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital mortality	up to 90 days	Hospital mortality

Secondary Outcome Measures

Name	Time	Method
Mortality Day 90	Day 90	Mortality Day 90
Ventilator-free days	Day 28	Ventilator-free days
Mortality Day 28	Day 28	Mortality Day 28
Hospital-free days	Day 28	Hospital-free days
Intensive care unit-free days	Day 28	ICU-free days

Trial Locations

Locations (44)

Angers University Hospital; 🇫🇷 Angers, France

Besançon Hospital; 🇫🇷 Besançon, France

Brest university Hospital; 🇫🇷 Brest, France

Caen University Hospital; 🇫🇷 Caen, France

Clermont ferrand University hospital; 🇫🇷 Clermont-Ferrand, France

APHP Henri Mondor Paris University Hospital; 🇫🇷 Créteil, France

Dijon University Hospital; 🇫🇷 Dijon, France

Vendée Hospital; 🇫🇷 La Roche-sur-Yon, France

Grenoble University Hospital; 🇫🇷 La Tronche, France

APHP Kremli Bicetre Paris University Hospital; 🇫🇷 Le Kremlin-Bicêtre, France

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