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
Intensive care unit-free days	Day 28	ICU-free days
Hospital-free days	Day 28	Hospital-free days

Trial Locations

Locations (44)

Nancy University Hospital; 🇫🇷 Nancy, France

La Réunion University Hospital; 🇫🇷 Saint-Denis, France

Saint Nazaire Hospital; 🇫🇷 Saint-Nazaire, France

Brest university Hospital; 🇫🇷 Brest, France

Bretagne Atlantique Hospital; 🇫🇷 Vannes, France

Lens Hospital; 🇫🇷 Lens, France

Limoges University Hospital; 🇫🇷 Limoges, France

Metz University Hospital; 🇫🇷 Metz, France

Lyon University Hospital; 🇫🇷 Lyon, France

Caen University Hospital; 🇫🇷 Caen, France

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

Angers University Hospital; 🇫🇷 Angers, France

Besançon Hospital; 🇫🇷 Besançon, France

Clairval Hospital; 🇫🇷 Marseille, France

APHP necker Paris University Hospital; 🇫🇷 Paris, France

Toulouse University Hospital - Rangueil Hospital; 🇫🇷 Toulouse, France

Tours University Hospital; 🇫🇷 Tours, France

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

Dijon University Hospital; 🇫🇷 Dijon, France

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

Marie Lannelongue Hospital; 🇫🇷 Le Plessis-Robinson, France

APHM la Timone- Marseille University Hospital; 🇫🇷 Marseille, France

Nimes University Hospital; 🇫🇷 Nimes, France

Montpellier University Hospital; 🇫🇷 Montpellier, France

Emile Muller Hospital; 🇫🇷 Mulhouse, France

Nantes University Hospital; 🇫🇷 Nantes, France

Ambroise Paré Hospital; 🇫🇷 Neuilly-sur-Seine, France

APHP La Pitié Salpêtrière Paris University Hospital; 🇫🇷 Paris, France

APHP Hopital Européen Georges Pompidou - Paris University Hospital; 🇫🇷 Paris, France

Bordeaux University Hospital; 🇫🇷 Pessac, France

Poitiers University hospital; 🇫🇷 Poitiers, France

Reims University hospital; 🇫🇷 Reims, France

Saint Etienne University Hospital; 🇫🇷 Saint-Étienne, France

Strasbourg University Hospital; 🇫🇷 Strasbourg, France

Saint brieuc Hospital; 🇫🇷 Saint brieuc, France

Marseille Européen Hospital; 🇫🇷 Marseille, France

Lille University Hospital; 🇫🇷 Lille, France

Clinique de la Sauvegarde; 🇫🇷 Lyon, France

Rennes University hospital; 🇫🇷 Rennes, France

APHP Bichat - Paris University Hospital; 🇫🇷 Paris, France

Grenoble University Hospital; 🇫🇷 La Tronche, France

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

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Rouen University Hospital; 🇫🇷 Rouen, France