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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04397588
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
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.

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

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

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study
Actual Study Start Date : April 21, 2020
Estimated Primary Completion Date : October 21, 2020
Estimated Study Completion Date : October 21, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Hospital mortality [ Time Frame: up to 90 days ]
    Hospital mortality


Secondary Outcome Measures :
  1. Mortality Day 28 [ Time Frame: Day 28 ]
    Mortality Day 28

  2. Mortality Day 90 [ Time Frame: Day 90 ]
    Mortality Day 90

  3. Ventilator-free days [ Time Frame: Day 28 ]
    Ventilator-free days

  4. Intensive care unit-free days [ Time Frame: Day 28 ]
    ICU-free days

  5. Hospital-free days [ Time Frame: Day 28 ]
    Hospital-free days



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill COVID-19 patients with ARDS or/and acute refractory heart failure
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397588


Contacts
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Contact: Cécile Ferragu 0299282555 cecile.ferragu@chu-rennes.fr
Contact: DRI 0299282555 dri@chu-rennes.fr

Locations
Show Show 44 study locations
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Nicolas Nesseler, doctor Rennes University Hospital
Principal Investigator: André Vincentelli, professor Lille University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04397588    
Other Study ID Numbers: 35RC20_8979 ECMO-SARS
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Rennes University Hospital:
ECMO
COVID-19
SARS-CoV2
ARDS
Myocarditis
Heart failure
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Heart Failure
Heart Diseases
Cardiovascular Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases