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

August 28, 2020 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49933
      • Besançon, France, 25030
      • Brest, France, 29200
      • Caen, France, 14033
        • Not yet recruiting
        • CAEN University Hospital
        • Contact:
      • Clermont-Ferrand, France, 63003
      • Créteil, France, 94000
      • Dijon, France, 21079
      • La Roche-sur-Yon, France, 85000
      • La Tronche, France, 38700
      • Le Kremlin-Bicêtre, France, 94275
        • Recruiting
        • APHP Kremli Bicetre Paris University Hospital
        • Contact:
      • Le Plessis-Robinson, France, 92350
        • Recruiting
        • Marie Lannelongue Hospital
        • Contact:
      • Lens, France, 62307
        • Not yet recruiting
        • Lens Hospital
        • Contact:
      • Lille, France, 59000
      • Limoges, France, 87042
      • Lyon, France, 69337
      • Lyon, France, 69500
      • Marseille, France, 13003
      • Marseille, France, 13005
        • Recruiting
        • APHM la Timone- Marseille University Hospital
        • Contact:
      • Marseille, France, 13009
      • Metz, France, 45000
      • Montpellier, France, 34090
      • Mulhouse, France, 68051
      • Nancy, France, 54511
      • Nantes, France, 44000
      • Neuilly-sur-Seine, France, 92200
      • Nimes, France, 30029
      • Paris, France, 75014
        • Recruiting
        • Institut Mutualiste Montsouris
        • Contact:
      • Paris, France, 75015
        • Recruiting
        • APHP Hopital Européen Georges Pompidou - Paris University Hospital
        • Contact:
      • Paris, France, 75015
      • Paris, France, 75018
      • Paris, France, 75651
      • Pessac, France, 33604
      • Poitiers, France, 86000
      • Reims, France, 51092
      • Rennes, France, 35000
      • Rouen, France, 76031
      • Saint brieuc, France, 22027
      • Saint-Denis, France, 97400
      • Saint-Nazaire, France, 44606
      • Saint-Étienne, France, 42000
      • Strasbourg, France, 67091
      • Toulouse, France, 31000
        • Recruiting
        • Toulouse University Hospital - Rangueil Hospital
        • Contact:
      • Tours, France, 37044
      • Vannes, France, 56000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill COVID-19 patients with ARDS or/and acute refractory heart failure

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital mortality
Time Frame: up to 90 days
Hospital mortality
up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality Day 28
Time Frame: Day 28
Mortality Day 28
Day 28
Mortality Day 90
Time Frame: Day 90
Mortality Day 90
Day 90
Ventilator-free days
Time Frame: Day 28
Ventilator-free days
Day 28
Intensive care unit-free days
Time Frame: Day 28
ICU-free days
Day 28
Hospital-free days
Time Frame: Day 28
Hospital-free days
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Nicolas Nesseler, doctor, Rennes University Hospital
  • Principal Investigator: André Vincentelli, professor, Lille University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2020

Primary Completion (Anticipated)

October 21, 2020

Study Completion (Anticipated)

October 21, 2020

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC20_8979 ECMO-SARS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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