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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

Tracking Information
First Submitted Date May 7, 2020
First Posted Date May 12, 2020
Last Update Posted Date May 21, 2020
Actual Study Start Date March 1, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2020)
In-hospital mortality [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 8, 2020)
  • Death on ECMO [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Stroke [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Blood stream infection [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Lung complications requiring surgical treatment [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Blood transfusion [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Acute kidney injury [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Duration of mechanical ventilation [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Deep vein thrombosis [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Pulmonary embolism [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Length of ICU stay [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Length of hospital stay [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
  • Death after hospital discharge [ Time Frame: During index hospital stay follow-up until 1 year after ECMO initiation ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome
Official Title Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Multicenter European Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • COVID-19
  • Extracorporeal Membrane Oxygenation Complication
  • Acute Respiratory Distress Syndrome
Intervention Device: Extracorporeal membrane oxygenation
Veno-venous or veno-arterial extracorporeal oxygenation
Study Groups/Cohorts COVID-19 positive patients
Intervention: Device: Extracorporeal membrane oxygenation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 8, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Fausto Biancari, Professor +358407333973 faustobiancari@yahoo.it
Contact: Magnus Dalén, Assoc prof
Listed Location Countries Finland,   France,   Germany,   Italy,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04383678
Other Study ID Numbers COVID-19 ECMO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fausto Biancari, Helsinki University Central Hospital
Study Sponsor Helsinki University Central Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Helsinki University Central Hospital
Verification Date May 2020