COVID-19NCT04383678
Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome
An observational study of COVID-19 and Extracorporeal Membrane Oxygenation Complication, run by Helsinki University Central Hospital at 11 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Extracorporeal Membrane Oxygenation Complication, Acute Respiratory Distress Syndrome
- What is being tested?
- Extracorporeal membrane oxygenation
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 1 Mar 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with PCR-confirmed or suspected COVID-19 infection with ARDS who require veno-venous or veno-arterial ECMO therapy
Who may be able to join
- PCR-confirmed or suspected COVID-19 infection with ARDS who require any ECMO therapy
Who cannot join
- None
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
France4 sites
University Hospital Jean Minjoz
Besançon
Nancy University Hospital
Nancy
Henri Mondon Unoversity Hospital
Paris
Robert Debré University Hospital
Reims
Germany2 sites
Hamburg University Heart Center
Hamburg
Münster University Hospital
Münster
About this study
Official title: Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Multicenter European Study
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.
Read the detailed description
We evaluated the outcome of adult patients with coronavirus disease 2019 (COVID-19)-related acute respiratory distress syndrome (ARDS) requiring the use of extracorporeal membrane oxygenation (ECMO).
- Conditions
- COVID-19, Extracorporeal Membrane Oxygenation Complication, Acute Respiratory Distress Syndrome
- Being tested
- Extracorporeal membrane oxygenation
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal membrane oxygenationDevice
Veno-venous or veno-arterial extracorporeal oxygenation
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive patients | Not described Receives: Device: Extracorporeal membrane oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
All-cause mortality
Measured: Immediately after the intervention/procedure/surgery
Secondary outcomes (12)
Death on ECMO
Death during ECMO therapy
Measured: During the intervention/procedure/surgery
Stroke
Stroke was defined as any focal or global neurological syndrome caused by ischemia and/or hemorrhage not resolving within 24 hours.
Measured: Immediately after the intervention/procedure/surgery
Blood stream infection
Blood stream infection detected on blood cultures
Measured: Immediately after the intervention/procedure/surgery
Lung complications requiring surgical treatment
Pneuthorax, pneumonia and/or abscess requiring surgical treatment
Measured: Immediately after the intervention/procedure/surgery
Blood transfusion
Transfusion of red blood cells
Measured: Immediately after the intervention/procedure/surgery
Acute kidney injury
Acute renal failure according to the Kidney Disease: Improving Global Outcomes classification (KDIGO) criteria
Measured: Immediately after the intervention/procedure/surgery
Duration of mechanical ventilation
Duration of mechanical ventilation
Measured: During index hospital stay follow-up until 1 year after ECMO initiation
Deep vein thrombosis
Thrombosis of lower limb deep venous system
Measured: Immediately after the intervention/procedure/surgery
Pulmonary embolism
Pulmonary embolism
Measured: Immediately after the intervention/procedure/surgery
Length of intensive care unit stay
Length of stay in the intensive care unit
Measured: Immediately after the intervention/procedure/surgery
Length of hospital stay
Length of hospital stay
Measured: Immediately after the intervention/procedure/surgery
Death after hospital discharge
All-cause death
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Mar 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fausto Biancari, Helsinki University Central Hospital
- Investigators
- Fausto Biancari, Professor, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383678
- Sponsor's protocol ID
- COVID-19 ECMO
- Status last verified
- Apr 2021
- First submitted
- 7 May 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biancari F, Mariscalco G, Dalen M, Settembre N, Welp H, Perrotti A, Wiebe K, Leo E, Loforte A, Chocron S, Pacini D, Juvonen T, Broman LM, Perna DD, Yusuff H, Harvey C, Mongardon N, Maureira JP, Levy B, Falk L, Ruggieri VG, Zipfel S, Folliguet T, Fiore A. Six-Month Survival After Extracorporeal Membrane Oxygenation for Severe COVID-19. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):1999-2006. doi: 10.1053/j.jvca.2021.01.027. Epub 2021 Jan 19.
PubMed 33573928
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Multicenter European Study
- ClinicalTrials.gov ID
- NCT04383678
- Acronym / sponsor ID
- COVID-19 ECMO
- Conditions
- COVID-19, Extracorporeal Membrane Oxygenation Complication, Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
We evaluated the outcome of adult patients with coronavirus disease 2019 (COVID-19)-related acute respiratory distress syndrome (ARDS) requiring the use of extracorporeal membrane oxygenation (ECMO).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive patients | – | Device: Extracorporeal membrane oxygenation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with PCR-confirmed or suspected COVID-19 infection with ARDS who require veno-venous or veno-arterial ECMO therapy
Key inclusion criteria (1 listed)
- PCR-confirmed or suspected COVID-19 infection with ARDS who require any ECMO therapy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal membrane oxygenationVeno-venous or veno-arterial extracorporeal oxygenation | Device | COVID-19 positive patients |
Primary outcome
In-hospital mortality
Time frame: Immediately after the intervention/procedure/surgery
All-cause mortality
12 secondary outcomes
Death on ECMO
Time frame: During the intervention/procedure/surgery
Stroke
Time frame: Immediately after the intervention/procedure/surgery
Blood stream infection
Time frame: Immediately after the intervention/procedure/surgery
Lung complications requiring surgical treatment
Time frame: Immediately after the intervention/procedure/surgery
Blood transfusion
Time frame: Immediately after the intervention/procedure/surgery
Acute kidney injury
Time frame: Immediately after the intervention/procedure/surgery
Duration of mechanical ventilation
Time frame: During index hospital stay follow-up until 1 year after ECMO initiation
Deep vein thrombosis
Time frame: Immediately after the intervention/procedure/surgery
Pulmonary embolism
Time frame: Immediately after the intervention/procedure/surgery
Length of intensive care unit stay
Time frame: Immediately after the intervention/procedure/surgery
Length of hospital stay
Time frame: Immediately after the intervention/procedure/surgery
Death after hospital discharge
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 33573928Biancari F, Mariscalco G, Dalen M, Settembre N, Welp H, Perrotti A, Wiebe K, Leo E, Loforte A, Chocron S, Pacini D, Juvonen T, Broman LM, Perna DD, Yusuff H, Harvey C, Mongardon N, Maureira JP, Levy B, Falk L, Ruggieri VG, Zipfel S, Folliguet T, Fiore A. Six-Month Survival After Extracorporeal Membrane Oxygenation for Severe COVID-19. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):1999-2006. doi: 10.1053/j.jvca.2021.01.027. Epub 2021 Jan 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fausto Biancari, Professor principal investigator
Helsinki University Central Hospital
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Extracorporeal Membrane Oxygenation Complication, run by Helsinki University Central Hospital at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Germany, Italy, Finland, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: Immediately after the intervention/procedure/surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.