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

NCT ID: NCT04397588

Last Updated: 2020-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-21

Study Completion Date

2020-10-21

Brief Summary

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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

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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

Conditions

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

Keywords

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ECMO COVID-19 SARS-CoV2 ARDS Myocarditis Heart failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Nesseler, doctor

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

André Vincentelli, professor

Role: PRINCIPAL_INVESTIGATOR

Lille University Hospital

Locations

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Angers University Hospital

Angers, , France

Site Status RECRUITING

Besançon Hospital

Besançon, , France

Site Status RECRUITING

Brest university Hospital

Brest, , France

Site Status NOT_YET_RECRUITING

Caen University Hospital

Caen, , France

Site Status NOT_YET_RECRUITING

Clermont ferrand University hospital

Clermont-Ferrand, , France

Site Status RECRUITING

APHP Henri Mondor Paris University Hospital

Créteil, , France

Site Status RECRUITING

Dijon University Hospital

Dijon, , France

Site Status RECRUITING

Vendée Hospital

La Roche-sur-Yon, , France

Site Status NOT_YET_RECRUITING

Grenoble University Hospital

La Tronche, , France

Site Status RECRUITING

APHP Kremli Bicetre Paris University Hospital

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Marie Lannelongue Hospital

Le Plessis-Robinson, , France

Site Status RECRUITING

Lens Hospital

Lens, , France

Site Status NOT_YET_RECRUITING

Lille University Hospital

Lille, , France

Site Status RECRUITING

Limoges University Hospital

Limoges, , France

Site Status NOT_YET_RECRUITING

Clinique de la Sauvegarde

Lyon, , France

Site Status RECRUITING

Lyon University Hospital

Lyon, , France

Site Status RECRUITING

Marseille Européen Hospital

Marseille, , France

Site Status RECRUITING

APHM la Timone- Marseille University Hospital

Marseille, , France

Site Status RECRUITING

Clairval Hospital

Marseille, , France

Site Status NOT_YET_RECRUITING

Metz University Hospital

Metz, , France

Site Status NOT_YET_RECRUITING

Montpellier University Hospital

Montpellier, , France

Site Status RECRUITING

Emile Muller Hospital

Mulhouse, , France

Site Status RECRUITING

Nancy University Hospital

Nancy, , France

Site Status RECRUITING

Nantes University Hospital

Nantes, , France

Site Status RECRUITING

Ambroise Paré Hospital

Neuilly-sur-Seine, , France

Site Status RECRUITING

Nimes University Hospital

Nîmes, , France

Site Status RECRUITING

Institut Mutualiste Montsouris

Paris, , France

Site Status RECRUITING

APHP Hopital Européen Georges Pompidou - Paris University Hospital

Paris, , France

Site Status RECRUITING

APHP necker Paris University Hospital

Paris, , France

Site Status RECRUITING

APHP Bichat - Paris University Hospital

Paris, , France

Site Status RECRUITING

APHP La Pitié Salpêtrière Paris University Hospital

Paris, , France

Site Status RECRUITING

Bordeaux University Hospital

Pessac, , France

Site Status RECRUITING

Poitiers University hospital

Poitiers, , France

Site Status RECRUITING

Reims University hospital

Reims, , France

Site Status RECRUITING

Rennes University hospital

Rennes, , France

Site Status RECRUITING

Rouen University Hospital

Rouen, , France

Site Status RECRUITING

Saint brieuc Hospital

Saint-Brieuc, , France

Site Status NOT_YET_RECRUITING

La Réunion University Hospital

Saint-Denis, , France

Site Status RECRUITING

Saint Etienne University Hospital

Saint-Etienne, , France

Site Status RECRUITING

Saint Nazaire Hospital

Saint-Nazaire, , France

Site Status RECRUITING

Strasbourg University Hospital

Strasbourg, , France

Site Status RECRUITING

Toulouse University Hospital - Rangueil Hospital

Toulouse, , France

Site Status RECRUITING

Tours University Hospital

Tours, , France

Site Status RECRUITING

Bretagne Atlantique Hospital

Vannes, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Cécile Ferragu

Role: CONTACT

Phone: 0299282555

Email: [email protected]

DRI

Role: CONTACT

Phone: 0299282555

Email: [email protected]

Facility Contacts

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Olivier Fouquet, Doctor

Role: primary

Guillaume Flicoteaux, Doctor

Role: primary

Olivier Huet, professor

Role: primary

Marc-Olivier FISCHER, Professor

Role: primary

Nicolas D'OSTREVY, Doctor

Role: primary

Nicolas Mongardon, Doctor

Role: primary

Pierre Guinot, Doctor

Role: primary

Gwenhaël COLIN, Doctor

Role: primary

Lucie Gaide-chevronnay, Doctor

Role: primary

Jordi Matiello, Doctor

Role: primary

Olaf Mercier, professor

Role: primary

Olivier Fabre, Doctor

Role: primary

André Vincentelli, Professor

Role: primary

Jerome Jouan, Doctor

Role: primary

Olivier DESEBBE, Doctor

Role: primary

Jean-Luc. Fellahi, Professor

Role: primary

Matthias CASTANIER, doctor

Role: primary

Alizée Porto, Doctor

Role: primary

Charles Chanavaz

Role: primary

Cyril Cadoz, Doctor

Role: primary

Philippe Gaudard, Doctor

Role: primary

Nicolas BISCHOFF, Doctor

Role: primary

Bruno Levy, Professor

Role: primary

Bertrand Rozec, Doctor

Role: primary

Stéphane Aubert, Doctor

Role: primary

Claire Roger, Doctor

Role: primary

Kais Brini, Doctor

Role: primary

Bernard Cholley, Professor

Role: primary

Claudio Barbanti, Doctor

Role: primary

Sophie Provenchère, Doctor

Role: primary

Guillaume Lebreton

Role: primary

Alexandre OUATTARA, Professor

Role: primary

Corentin Lacroix, Doctor

Role: primary

Vito Giovanni Ruggieri, Professor

Role: primary

Nicolas Nesseler, Doctor

Role: primary

Emmanuel Besnier, Doctor

Role: primary

Pierre Fillatre, Doctor

Role: primary

Nicolas Allou, Doctor

Role: primary

Roxane NICOLAS

Role: primary

Maud Jonas

Role: primary

Pierre-Emmanuel Falcoz, Professor

Role: primary

François Labaste, Doctor

Role: primary

Antoine Guillon, Doctore

Role: primary

Yannick Fedun, Doctor

Role: primary

References

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Nesseler N, Mansour A, Schmidt M, Para M, Porto A, Falcoz PE, Mongardon N, Fougerou C, Ross JT, Beurton A, Gaide-Chevronnay L, Guinot PG, Lebreton G, Flecher E, Vincentelli A, Massart N; ECMOSARS Investigators; SFAR Research Network. Healthcare-associated infections in patients with severe COVID-19 supported with extracorporeal membrane oxygenation: a nationwide cohort study. Crit Care. 2024 Feb 20;28(1):54. doi: 10.1186/s13054-024-04832-3.

Reference Type DERIVED
PMID: 38374103 (View on PubMed)

Massart N, Guervilly C, Mansour A, Porto A, Flecher E, Esvan M, Fougerou C, Fillatre P, Duburcq T, Lebreton G, Para M, Stephan F, Hraiech S, Ross JT, Schmidt M, Vincentelli A, Nesseler N; Extracorporeal Membrane Oxygenation for Respiratory Failure and/or Heart failure related to Severe Acute Respiratory Syndrome Coronavirus 2 (ECMOSARS) Investigators. Impact of Prone Position in COVID-19 Patients on Extracorporeal Membrane Oxygenation. Crit Care Med. 2023 Jan 1;51(1):36-46. doi: 10.1097/CCM.0000000000005714. Epub 2022 Nov 11.

Reference Type DERIVED
PMID: 36519982 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35829723 (View on PubMed)

Other Identifiers

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35RC20_8979 ECMO-SARS

Identifier Type: -

Identifier Source: org_study_id