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Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome

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: NCT04383678
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Fausto Biancari, Helsinki University Central Hospital

Study Description
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Brief Summary:
This study aims to investigate outcomes and predictors of outcome after extracorporeal membrane oxygenation (ECMO) therapy for severe acute respiratory syndrome (ARDS) in COVID-19 patients.

Condition or disease Intervention/treatment
COVID-19 Extracorporeal Membrane Oxygenation Complication Acute Respiratory Distress Syndrome Device: Extracorporeal membrane oxygenation

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Multicenter European Study
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
COVID-19 positive patients Device: Extracorporeal membrane oxygenation
Veno-venous or veno-arterial extracorporeal oxygenation


Outcome Measures
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Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]

Secondary Outcome Measures :
  1. Death on ECMO [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  2. Stroke [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  3. Blood stream infection [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  4. Lung complications requiring surgical treatment [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  5. Blood transfusion [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  6. Acute kidney injury [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  7. Duration of mechanical ventilation [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  8. Deep vein thrombosis [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  9. Pulmonary embolism [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  10. Length of ICU stay [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  11. Length of hospital stay [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  12. Death after hospital discharge [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]

Eligibility Criteria
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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
Patients with PCR-confirmed or suspected COVID-19 infection with ARDS who require veno-venous or veno-arterial ECMO therapy
Criteria

Inclusion Criteria:

  • PCR-confirmed or suspected COVID-19 infection with ARDS who require any ECMO therapy

Exclusion Criteria:

  • None
Contacts and Locations
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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): NCT04383678


Contacts
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Contact: Fausto Biancari, Professor +358407333973 faustobiancari@yahoo.it
Contact: Magnus Dalén, Assoc prof

Locations
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Finland
Helsinki University Hospital Not yet recruiting
Helsinki, Finland
Contact: Fausto Biancari         
France
University Hospital Jean Minjoz Recruiting
Besançon, France
Contact: Andrea Perrotti         
Nancy University Hospital Recruiting
Nancy, France
Contact: Nicla Settembre         
Henri Mondon Unoversity Hospital Recruiting
Paris, France
Contact: Antonio Fiore         
Robert Debré University Hospital Recruiting
Reims, France
Contact: Vito G Ruggieri         
Germany
Hamburg University Heart Center Recruiting
Hamburg, Germany
Contact: Svante Zipfel         
Münster University Hospital Recruiting
Münster, Germany
Contact: Henryk Welp         
Italy
S. Orsola Hospital Recruiting
Bologna, Italy
Contact: Antonio Loforte         
Lecco Hospital Recruiting
Lecco, Italy
Contact: Enrico Leo         
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Magnus Dalén         
Sub-Investigator: Lars M Broman         
United Kingdom
University Hospitals of Leicester Recruiting
Leicester, United Kingdom
Contact: Giovanni Mariscalco         
Sponsors and Collaborators
Helsinki University Central Hospital
More Information
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Responsible Party: Fausto Biancari, Professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04383678    
Other Study ID Numbers: COVID-19 ECMO
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury