RecruitingACTRN12620000421932

COVID-19 Critical Care Consortium Observational Study Incorporating the Extracorporeal Membrane Oxygenation for 2019 Novel Coronavirus Acute Respiratory Disease (ECMOCARD)


Sponsor

Extracorporeal Life Support Organisation

Enrollment

10,000 participants

Start Date

Mar 5, 2020

Study Type

Observational

Conditions

Summary

We hypothesize that a significant percentage of patients with suspected or confirmed COVID-19 infection will require admission to the intensive care unit, mechanical ventilation and ECMO for refractory hypoxemia., In addition, it is hypothesized that a substantial proportion of patients will also present with concurrent coagulation disorders and thrombosis. Objectives: To describe clinical features; severity of pulmonary dysfunction; incidence of ICU admission and use of mechanical ventilation, coagulatory and thrombotic derangement, and ECMO technical characteristics; duration of ECMO; complications; and survival of patients with suspected or confirmed COVID-19.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

COVID-19 can cause severe respiratory illness requiring intensive care support. This international observational registry study tracks patients with confirmed or suspected COVID-19 who are admitted to intensive care units, with a particular focus on those who require mechanical ventilation or ECMO (extracorporeal membrane oxygenation — a life support machine that does the work of the lungs). The study also examines blood clotting problems, which are common in severe COVID-19. There is no experimental treatment in this study. Instead, clinical teams at participating ICUs around the world record detailed information about their COVID-19 patients' illness course, treatments used, complications, and survival outcomes. This data helps build a global picture of how the disease affects critically ill patients and how different treatment strategies compare. You may be eligible if you are admitted to an intensive care unit at a participating centre with confirmed or clinically suspected COVID-19 infection. The study does not have specific age restrictions. Patients on mechanical ventilation or ECMO for reasons unrelated to COVID-19 are not eligible.

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Interventions

In patients with suspected or confirmed 2019-nCoV who require admission to the intensive care unit mechanical ventilation and extracorporeal membrane oxygenation (ECMO). It is expected that this study

In patients with suspected or confirmed 2019-nCoV who require admission to the intensive care unit mechanical ventilation and extracorporeal membrane oxygenation (ECMO). It is expected that this study will not require individual patient consent. This study is in effect a large-scale clinical audit during a global health emergency, as all data is already recorded as part of routine clinical care, therefore justifying participant enrolment using a waiver of consent. Retrospective data will be sourced from all collaborating hospitals across Australia from January 2020 to March 2020. Whereas, international hospitals will provide their retrospective data between January 2019 and march 2020. Prospective data will be collected in Australian and International hospitals until completion of COVID-19 global epidemic, as judged by the World Health Organization. The total duration of observation per participant will be until hospital discharge or 28 days post intensive care unit admission, whichever comes later. The study will combine prospective observation, and retrospective observations sourced from clinical charts.


Locations(45)

Hong Kong

Taiwan, Province Of China

Indonesia

Korea, Republic Of

Japan

Italy

Singapore

Viet Nam

Thailand

United Kingdom

United States of America

Taiwan, Province Of China

Netherlands

Belgium

Kuwait

Saudi Arabia

Austria

Philippines

Estonia

Canada

India

Spain

Argentina

Colombia

Chile

Germany

Brazil

Ireland

Poland

South Africa

Qatar

Egypt

Sweden

Croatia

Luxembourg

Ukraine

Switzerland

Turkey

Mexico

United Arab Emirates

Lebanon

Kenya

Tunisia

Zimbabwe

Error, Morocco

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