European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO (EuroECMO-COVID)

• ClinicalTrials.gov Identifier: NCT04366921
• Recruitment Status: Recruiting
• First Posted: April 29, 2020
• Last Update Posted: September 5, 2021
• Sponsor: Maastricht University Medical Center
• Collaborators: European chapter of the Extracorporeal Life Support Organization; Erasmus Medical Center; Leiden University Medical Center; UMC Utrecht; IRCCS Azienda Ospedaliero-Universitaria di Bologna; Papa Giovanni XXIII Hospital; Niguarda Hospital; Ospedale San Donato; Ospedale S. Giovanni Bosco; IRCCS Policlinico S. Matteo; The Mediterranean Institute for Transplantation and Advanced Specialized Therapies; Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia; Ospedale dell'Angelo, Venezia-Mestre; University Hospital, Udine, Italy; San Gerardo Hospital; Ospedali Riuniti Ancona; San Camillo Hospital, Rome; San Giorgio Clinic; GVM Care & Research; San Raffaele University Hospital, Italy; Ospedale San Bortolo di Vicenza; Klinik Hirslanden, Zurich; University of Zurich; Cardiocentro Ticino; Vilnius University Hospital Santaros Klinikos; Universitätsklinikum Düsseldorf; Klinikum Nürnberg; Hannover Medical School; Heart Center Leipzig - University Hospital; University Hospital Regensburg; University Hospital, Essen; German Heart Center; University Hospital, Aachen; University Heart Center Freiburg - Bad Krozingen; Klinikum Kassel; General University Hospital, Prague; Universitaire Ziekenhuizen KU Leuven; Onze Lieve Vrouwziekenhuis Aalst; Erasme University Hospital; University Hospital, Antwerp; Hôpital Civil Marie Curie de Charleroi; University Hospital, Ghent; Centre Hospitalier Universitaire Saint Pierre; Hospital Vall d'Hebron; Hospital Universitario Ramon y Cajal; Hospital Miguel Servet; Henri Mondor University Hospital; Hospices Civils de Lyon; Pitié-Salpêtrière Hospital; Rennes University Hospital; Guy's and St Thomas' NHS Foundation Trust; Karolinska University Hospital; Hospital Sao Joao; Medical University of Warsaw; Universitätskliniken Innsbruck; Medical University of Vienna; University Hospital, Alexandroupolis; Novosibirsk City Hospital #2; City Clinical Hospital No. 67, Moscow, Russia; City Hospital No 40, Saint Petersburg, Russia; Krasnodar Regional Hospital no 1; Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash; City Hospital No 41, Ekaterinburg, Russia; G. Pasquinucci Heart Hospital, Massa; Charles University, Czech Republic; University Hospital, Bordeaux; Bambino Gesù Hospital and Research Institute; Policlinico Hospital Milan; Gaslini Children's Hospital; Children's Medical Hospital, University of Essen, Essen, Germany; University Hospital, Geneva; Newcastle-upon-Tyne Hospitals NHS Trust; Paediatric Intensive Care Glasgow; Paris South University Hospitals; University of Groningen; Great Ormond Street Hospital for Children NHS Foundation Trust; Hospital Sant Joan de Deu; Heim Pal Children's Hospital; University Hospital, Montpellier; Royal Brompton & Harefield NHS Foundation Trust; Lund University Hospital; Landesklinikum Sankt Polten; Chelyabinsk Regional Clinical Hospital; ECMO Centers Israel; Copenhagen University Hospital at Herlev; Ospedale M. Bufalini Cesena; A.O.U. Città della Salute e della Scienza - Molinette Hospital; Mauriziano Umberto I Hospital; University of Bern; University Hospital, Basel, Switzerland; University of Lausanne Hospitals; University Hospital Tuebingen; Universitätsklinikum Köln; Chirec; Universitair Ziekenhuis Brussel; Centre Hospitalier Universitaire de Liege; La Louvière Hopital; Leicester Royal Infirmary NHS Trust
• Information provided by (Responsible Party): Maastricht University Medical Center

Tracking Information

• First Submitted Date: April 17, 2020
• First Posted Date: April 29, 2020
• Last Update Posted Date: September 5, 2021
• Actual Study Start Date: April 10, 2020
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2020)

• Age [ Time Frame: at baseline ]
  age in years
• Gender [ Time Frame: at baseline ]
  male/female
• Weight [ Time Frame: at baseline ]
  in kilograms
• Height [ Time Frame: at baseline ]
  in meters
• BMI [ Time Frame: at baseline ]
  weight and height combined to calculate BMI in kg/m^2
• Pre-existing pulmonary disease y/n [ Time Frame: at baseline ]
  Asthma y/n, cystic fibrosis y/n, chronic obstructive pulmonary disease y/n, pulmonary hypertension y/n, pulmonary fibrosis y/n, chronic restrictive lung disease y/n
• Main co-morbidities y/n [ Time Frame: at baseline ]
  diabetes mellitus y/n, chronic renal failure y/n, ischemic heart disease y/n, heart failure y/n, chronic liver failure y/n, neurological impairment y/n
• Date of signs of COVID-19 infection [ Time Frame: at baseline or date of occurence ]
  in dd-mm-yyyy or mm-dd-yyyy
• Date of positive swab [ Time Frame: at baseline or date of occurence ]
  in dd-mm-yyyy or mm-dd-yyyy
• Pre-ECMO length of hospital stay [ Time Frame: at or during ECMO-implant ]
  in days
• Pre-ECMO length of ICU stay [ Time Frame: at or during ECMO-implant ]
  in days
• Pre-ECMO length of mechanical ventilation days [ Time Frame: at or during ECMO-implant ]
  in days
• Use of antibiotics [ Time Frame: up to 6 months ]
  y/n, what kind
• Use of anti-viral treatment [ Time Frame: up to 6 months ]
  y/n, what kind
• Use of second line treatment [ Time Frame: up to 6 months ]
  y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)
• Indications for ECMO-implant [ Time Frame: at ECMO-implant ]
  respiratory or cardiac
• Type of ECMO-implant [ Time Frame: at ECMO-implant ]
  veno-venous, veno-arterial or veno-venoarterial
• Type of access [ Time Frame: at ECMO-implant ]
  peripheral or central
• Date of ECMO implant [ Time Frame: at ECMO-implant ]
  in dd-mm-yyyy or mm-dd-yyyy
• ECMO blood flow rate [ Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months ]
  l/min
• ECMO gas flow rate [ Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months ]
  l/min
• ECMO configuration change [ Time Frame: up to 6 months ]
  y/n
• Date of ECMO configuration change [ Time Frame: up to 6 months ]
  in dd-mm-yyyy or mm-dd-yyyy
• New ECMO configuration [ Time Frame: up to 6 months ]
  veno-venous, veno-arterial, veno-venoarterial, other
• Indications for ECMO configuration change [ Time Frame: up to 6 months ]
  right ventricular failure, left ventricular failure, refractory hypoxemia
• Ventilator setting on ECMO [ Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months ]
  settings of ventilator
• Anticoagulation during ECMO [ Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months ]
  heparin, bivalirudin, nothing
• Frequency of ECMO circuit change [ Time Frame: up to 6 months ]
  amount of ECMO circuit changes (1, 2, 3 etc.)
• ECMO complications [ Time Frame: up to 6 months ]
  Hemorrhagic, infection, other complications
• ECMO Weaning [ Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months ]
  y/n
• ICU discharge [ Time Frame: from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months ]
  y/n, date
• Main cause of death [ Time Frame: 6 months ]
• Type of discharge [ Time Frame: up to 6 months ]
  Ward, another ICU, rehabilitation center, home
• Alive/deceased [ Time Frame: 6 months ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO
• Official Title: European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO

Brief Summary

In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally.

In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively.

Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%.

The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality.

Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project.

The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: patients with confirmed COVID-19 infection who require ECMO support

Condition

• COVID
• SARS-CoV-2
• ARDS, Human
• Refractory Hypoxemia
• Cardiogenic Shock
• Septic Shock
• Extracorporeal Membrane Oxygenation

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Bolotin S, Pebody R, White PJ, McMenamin J, Perera L, Nguyen-Van-Tam JS, Barlow T, Watson JM; UK Severe Influenza Surveillance System (USISS) Steering Group. A new sentinel surveillance system for severe influenza in England shows a shift in age distribution of hospitalised cases in the post-pandemic period. PLoS One. 2012;7(1):e30279. doi: 10.1371/journal.pone.0030279. Epub 2012 Jan 23.
• Dawood FS, Iuliano AD, Reed C, Meltzer MI, Shay DK, Cheng PY, Bandaranayake D, Breiman RF, Brooks WA, Buchy P, Feikin DR, Fowler KB, Gordon A, Hien NT, Horby P, Huang QS, Katz MA, Krishnan A, Lal R, Montgomery JM, Molbak K, Pebody R, Presanis AM, Razuri H, Steens A, Tinoco YO, Wallinga J, Yu H, Vong S, Bresee J, Widdowson MA. Estimated global mortality associated with the first 12 months of 2009 pandemic influenza A H1N1 virus circulation: a modelling study. Lancet Infect Dis. 2012 Sep;12(9):687-95. doi: 10.1016/S1473-3099(12)70121-4. Epub 2012 Jun 26. Erratum In: Lancet Infect Dis. 2012 Sep;12(9):655.
• Simonsen L, Spreeuwenberg P, Lustig R, Taylor RJ, Fleming DM, Kroneman M, Van Kerkhove MD, Mounts AW, Paget WJ; GLaMOR Collaborating Teams. Global mortality estimates for the 2009 Influenza Pandemic from the GLaMOR project: a modeling study. PLoS Med. 2013 Nov;10(11):e1001558. doi: 10.1371/journal.pmed.1001558. Epub 2013 Nov 26.
• Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.
• Drosten C, Gunther S, Preiser W, van der Werf S, Brodt HR, Becker S, Rabenau H, Panning M, Kolesnikova L, Fouchier RA, Berger A, Burguiere AM, Cinatl J, Eickmann M, Escriou N, Grywna K, Kramme S, Manuguerra JC, Muller S, Rickerts V, Sturmer M, Vieth S, Klenk HD, Osterhaus AD, Schmitz H, Doerr HW. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1967-76. doi: 10.1056/NEJMoa030747. Epub 2003 Apr 10.
• Ksiazek TG, Erdman D, Goldsmith CS, Zaki SR, Peret T, Emery S, Tong S, Urbani C, Comer JA, Lim W, Rollin PE, Dowell SF, Ling AE, Humphrey CD, Shieh WJ, Guarner J, Paddock CD, Rota P, Fields B, DeRisi J, Yang JY, Cox N, Hughes JM, LeDuc JW, Bellini WJ, Anderson LJ; SARS Working Group. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1953-66. doi: 10.1056/NEJMoa030781. Epub 2003 Apr 10.
• Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17. Erratum In: N Engl J Med. 2013 Jul 25;369(4):394.
• de Groot RJ, Baker SC, Baric RS, Brown CS, Drosten C, Enjuanes L, Fouchier RA, Galiano M, Gorbalenya AE, Memish ZA, Perlman S, Poon LL, Snijder EJ, Stephens GM, Woo PC, Zaki AM, Zambon M, Ziebuhr J. Middle East respiratory syndrome coronavirus (MERS-CoV): announcement of the Coronavirus Study Group. J Virol. 2013 Jul;87(14):7790-2. doi: 10.1128/JVI.01244-13. Epub 2013 May 15. No abstract available.
• Spina S, Marrazzo F, Migliari M, Stucchi R, Sforza A, Fumagalli R. The response of Milan's Emergency Medical System to the COVID-19 outbreak in Italy. Lancet. 2020 Mar 14;395(10227):e49-e50. doi: 10.1016/S0140-6736(20)30493-1. Epub 2020 Feb 28. No abstract available.
• Ebrahim SH, Memish ZA. COVID-19: preparing for superspreader potential among Umrah pilgrims to Saudi Arabia. Lancet. 2020 Mar 14;395(10227):e48. doi: 10.1016/S0140-6736(20)30466-9. Epub 2020 Feb 27. No abstract available.
• Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.
• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
• Lorusso R, De Piero ME, Mariani S, Di Mauro M, Folliguet T, Taccone FS, Camporota L, Swol J, Wiedemann D, Belliato M, Broman LM, Vuylsteke A, Kassif Y, Scandroglio AM, Fanelli V, Gaudard P, Ledot S, Barker J, Boeken U, Maier S, Kersten A, Meyns B, Pozzi M, Pedersen FM, Schellongowski P, Kirali K, Barrett N, Riera J, Mueller T, Belohlavek J; EuroECMO-COVID Study Group. In-hospital and 6-month outcomes in patients with COVID-19 supported with extracorporeal membrane oxygenation (EuroECMO-COVID): a multicentre, prospective observational study. Lancet Respir Med. 2023 Feb;11(2):151-162. doi: 10.1016/S2213-2600(22)00403-9. Epub 2022 Nov 16.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 28, 2020): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2022
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Laboratory-confirmed COVID-19 infection by real-time PCR (polymerase chain reaction)
• ECMO for treatment severe lung disease COVID-19 related

Exclusion Criteria:

• Patients treated with ECMO for other concomitant causes.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Lorusso, Prof. Dr.; + 31(0) 433877095; roberto.lorussobs@gmail.com

• Listed Location Countries: Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, United Kingdom

Administrative Information

• NCT Number: NCT04366921
• Other Study ID Numbers: METC 2020-1343
• 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

• Current Responsible Party: Maastricht University Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Maastricht University Medical Center
• Original Study Sponsor: Same as current

Collaborators

• European chapter of the Extracorporeal Life Support Organization
• Erasmus Medical Center
• Leiden University Medical Center
• UMC Utrecht
• IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Papa Giovanni XXIII Hospital
• Niguarda Hospital
• Ospedale San Donato
• Ospedale S. Giovanni Bosco
• IRCCS Policlinico S. Matteo
• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Ospedale dell'Angelo, Venezia-Mestre
• University Hospital, Udine, Italy
• San Gerardo Hospital
• Ospedali Riuniti Ancona
• San Camillo Hospital, Rome
• San Giorgio Clinic
• GVM Care & Research
• San Raffaele University Hospital, Italy
• Ospedale San Bortolo di Vicenza
• Klinik Hirslanden, Zurich
• University of Zurich
• Cardiocentro Ticino
• Vilnius University Hospital Santaros Klinikos
• Universitätsklinikum Düsseldorf
• Klinikum Nürnberg
• Hannover Medical School
• Heart Center Leipzig - University Hospital
• University Hospital Regensburg
• University Hospital, Essen
• German Heart Center
• University Hospital, Aachen
• University Heart Center Freiburg - Bad Krozingen
• Klinikum Kassel
• General University Hospital, Prague
• Universitaire Ziekenhuizen KU Leuven
• Onze Lieve Vrouwziekenhuis Aalst
• Erasme University Hospital
• University Hospital, Antwerp
• Hôpital Civil Marie Curie de Charleroi
• University Hospital, Ghent
• Centre Hospitalier Universitaire Saint Pierre
• Hospital Vall d'Hebron
• Hospital Universitario Ramon y Cajal
• Hospital Miguel Servet
• Henri Mondor University Hospital
• Hospices Civils de Lyon
• Pitié-Salpêtrière Hospital
• Rennes University Hospital
• Guy's and St Thomas' NHS Foundation Trust
• Karolinska University Hospital
• Hospital Sao Joao
• Medical University of Warsaw
• Universitätskliniken Innsbruck
• Medical University of Vienna
• University Hospital, Alexandroupolis
• Novosibirsk City Hospital #2
• City Clinical Hospital No. 67, Moscow, Russia
• City Hospital No 40, Saint Petersburg, Russia
• Krasnodar Regional Hospital no 1
• Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
• City Hospital No 41, Ekaterinburg, Russia
• G. Pasquinucci Heart Hospital, Massa
• Charles University, Czech Republic
• University Hospital, Bordeaux
• Bambino Gesù Hospital and Research Institute
• Policlinico Hospital Milan
• Gaslini Children's Hospital
• Children's Medical Hospital, University of Essen, Essen, Germany
• University Hospital, Geneva
• Newcastle-upon-Tyne Hospitals NHS Trust
• Paediatric Intensive Care Glasgow
• Paris South University Hospitals
• University of Groningen
• Great Ormond Street Hospital for Children NHS Foundation Trust
• Hospital Sant Joan de Deu
• Heim Pal Children's Hospital
• University Hospital, Montpellier
• Royal Brompton & Harefield NHS Foundation Trust
• Lund University Hospital
• Landesklinikum Sankt Polten
• Chelyabinsk Regional Clinical Hospital
• ECMO Centers Israel
• Copenhagen University Hospital at Herlev
• Ospedale M. Bufalini Cesena
• A.O.U. Città della Salute e della Scienza - Molinette Hospital
• Mauriziano Umberto I Hospital
• University of Bern
• University Hospital, Basel, Switzerland
• University of Lausanne Hospitals
• University Hospital Tuebingen
• Universitätsklinikum Köln
• Chirec
• Universitair Ziekenhuis Brussel
• Centre Hospitalier Universitaire de Liege
• La Louvière Hopital
• Leicester Royal Infirmary NHS Trust

Investigators

• Principal Investigator: Lorusso, Prof. Dr.; Maastricht University Hospital

• PRS Account: Maastricht University Medical Center
• Verification Date: August 2021