Clinical trial NCT04397588: Extracorporeal Membrane Oxygenation (ECMO) and Coronavirus Disease (COVID) 19
Official title: Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2
Acute Refractory Heart Failure Related to SARS-CoV 2
Keywords: ECMO
COVID-19
SARS-CoV2
ARDS
Myocarditis
Heart failure
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill COVID-19 patients with ARDS or/and acute refractory heart failure

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

Eligibility criteria: 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

Primary outcomes:
measure: Hospital mortality
timeFrame: up to 90 days
Secondary outcomes:
measure: Mortality Day 28
timeFrame: Day 28
measure: Mortality Day 90
timeFrame: Day 90
measure: Ventilator-free days
timeFrame: Day 28
measure: Intensive care unit-free days
timeFrame: Day 28
measure: Hospital-free days
timeFrame: Day 28
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Besançon
country: France
facility: Besançon Hospital
city: Brest
country: France
facility: Brest university Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont ferrand University hospital
city: Créteil
country: France
facility: APHP Henri Mondor Paris University Hospital
city: Dijon
country: France
facility: Dijon University Hospital
city: La Roche-sur-Yon
country: France
facility: Vendée Hospital
city: La Tronche
country: France
facility: Grenoble University Hospital
city: Le Kremlin-Bicêtre
country: France
facility: APHP Kremli Bicetre Paris University Hospital
city: Le Plessis-Robinson
country: France
facility: Marie Lannelongue Hospital
city: Lens
country: France
facility: Lens Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Limoges
country: France
facility: Limoges University Hospital
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Lyon
country: France
facility: Lyon University Hospital
city: Marseille
country: France
facility: Marseille Européen Hospital
city: Marseille
country: France
facility: APHM la Timone- Marseille University Hospital
city: Marseille
country: France
facility: Clairval Hospital
city: Metz
country: France
facility: Metz University Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Mulhouse
country: France
facility: Emile Muller Hospital
city: Nancy
country: France
facility: Nancy University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Neuilly-sur-Seine
country: France
facility: Ambroise Paré Hospital
city: Nimes
country: France
facility: Nimes University Hospital
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: APHP Hopital Européen Georges Pompidou - Paris University Hospital
city: Paris
country: France
facility: APHP necker Paris University Hospital
city: Paris
country: France
facility: APHP Bichat - Paris University Hospital
city: Paris
country: France
facility: APHP La Pitié Salpêtrière Paris University Hospital
city: Pessac
country: France
facility: Bordeaux University Hospital
city: Poitiers
country: France
facility: Poitiers University hospital
city: Reims
country: France
facility: Reims University hospital
city: Rennes
country: France
facility: Rennes University hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Saint brieuc
country: France
facility: Saint brieuc Hospital
city: Saint-Denis
country: France
facility: La Réunion University Hospital
city: Saint-Nazaire
country: France
facility: Saint Nazaire Hospital
city: Saint-Étienne
country: France
facility: Saint Etienne University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital - Rangueil Hospital
city: Tours
country: France
facility: Tours University Hospital
city: Vannes
country: France
facility: Bretagne Atlantique Hospital
Study officials:
affiliation: Rennes University Hospital
name: Nicolas Nesseler, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Lille University Hospital
name: André Vincentelli, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mansour A, Flecher E, Schmidt M, Rozec B, Gouin-Thibault I, Esvan M, Fougerou C, Levy B, Porto A, Ross JT, Para M, Manganiello S, Lebreton G, Vincentelli A, Nesseler N; ECMOSARS Investigators. Bleeding and thrombotic events in patients with severe COVID-19 supported with extracorporeal membrane oxygenation: a nationwide cohort study. Intensive Care Med. 2022 Aug;48(8):1039-1052. doi: 10.1007/s00134-022-06794-y. Epub 2022 Jul 13.