ACTRN12620000421932
Country
Chile
India
Indonesia
Japan
Philippines (the)
Korea (the Republic of)
Singapore
Thailand
United Arab Emirates (the)
Germany
Sweden
Italy
Netherlands (the)
Spain
Switzerland
United Kingdom of Great Britain and Northern Ireland (the)
Canada
Saudi Arabia
Egypt
Belgium
Argentina
Poland
Turkey
Brazil
Mexico
Ireland
Kenya
Unique trial registry identifier
ACTRN12620000421932
Date the clinical trial record was first registered with the source clinical trial registry
2020-03-30
Additional unique registration identifiers if the trial was registered with multiple clinical trial registries
-
Short hand reference or acronym assigned to the study. E.g. NOSO-COR; SOLID-C19; SOLIDARITY
ECMOCARD
Source
ANZCTR
Recruitment Status
Recruiting
Trial Phase
Not Applicable
Estimated Study Start Date (YYYY-MM-DD)
2020-03-05
Estimated Primary Completion Date (YYYY-MM-DD)
2020-12-31
Estimated Study Completion Date (YYYY-MM-DD)
2020-12-31
Study Design
Prognostic
Treatment Category
No intervention
Others
Active Pharmaceutical Ingredient (API)
Total number of participants planned across all arms
10000
Study eligibility age min
Unknown
Study eligibility age max
Unknown
Were patients with a confirmed COVID-19 diagnosis included?
Yes
Was enrolment of health workers an inclusion criterion?
No
Further details on the eligibility criteria of health workers
-
Were healthy volunteers included in this study?
No
Were pregnant women eligible for enrolment?
Unknown
Further details on the eligibility criteria of pregnant participants
-
List of planned outcome measures as reported in WHO ICTRP
Mortality[At hospital discharge or 28 days post intensive care unit admission, whichever comes later. ]
Any further details of planned outcomes reported in source registry
Through assessment of medical records we will compute incidence of intensive care unit admission among patients diagnosed with 2019-nCoV infection; Cardiac arrest, Assessed through medical records; Location of ECMO cannulation, Assessed through medical records; ECMO blood flow rate; Type and source of infectious complications, i.e. ventilator-associated pneumonia, assessed through medical records and data-linkage to medical records; Length of hospital Stay; Ventilatory support prior to mechanical ventilation; Blood gas analysis; Use of vasoactive drugs; Use of cardiac assist devices; Antibiotics; Type and Manufacturer of centrifugal blood pump driven circuit; Type and Manufacturer of low-resistance oxygenator; Type of ECMO: Venous-venous; Venous-arterial; Cardiac arrest; Ventilatory settings prior to ECMO; Body position before start of ECMO; Use of neuromuscular blockade; Use of inhaled nitric oxide; Arterial blood gases; Use of continuous renal replacement therapy ; Use of vasoactive drugs; Use of cardiac assist devices; Anticoagulation during ECMO; Frequency of ECMO circuit change; Organ dysfunctions; Transfused blood products; Type and source of hemorrhagic complications, i.e. subarachnoid haemorrhage, assessed through medical chart and data-linkage to medical chart; Other complications, i.e. pneumothorax assessed through medical chart and data linkage to medical chart; Duration of mechanical ventilation; Duration of ECMO
Have the results of the clinical trial been published?
No
Web address or URL link of the source/original registry record
URL / weblink to the published results
-
Date that the results were published
-
Does this study plan to share IPD?
Yes
Details of plans to share IPD
All of the individual non-identifiable participant data collected during the study will be available; from 31/05/2020
In addition IPD will be kept and made available for 5 years to other scientific societies and researchers only to achieve the aims in the approved proposal made by the potential collaborative society/researcher
By emailing the principal investigator:
Gianluigi Li Bassi, MD, PhD
g.libassi@uq.edu.au
Details of study components
Extracorporeal membrane oxygenation (ECMO); No intervention for patients with 2019-nCoV who require admission to intensive care and do not require mechanical ventilation or ECMO.
Date of Last Review
2022-02-12