Clinical trial NCT04416256: COVID-19 Pandemic and Worldwide Organ Procurement
Official title: Consequences of the COVID-19 Pandemic on Worldwide Organ Procurement and Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: organ
procurement
transplantation
pandemic
Lead sponsor: Paris Translational Research Center for Organ Transplantation
Sponsor class: OTHER
Collaborators: name: Agence de La Biomédecine
name: Eurotransplant
name: United Network for Organ Sharing
name: Deutsche Stiftung Organtransplantation
name: Centro Nazionale Trapianti
name: Brazilian Organ Transplant Association
name: The Canadian Association of Transplantation
name: Scandiatransplant
name: Nederlandse Transplantatie Vereniging
name: Austrotransplant
name: Centro Nacional de Trasplantes
name: Instituto Nacional de Donación y Trasplante de Células, Tejidos y Órganos
name: Donor Network of Croatia
name: Instituto Nacional Central Único Coordinador de Ablación e Implante
name: Corporación Nacional de Trasplantes de Chile
name: Australian Organ and Tissue Donation and Transplantation Authority
name: Organización Nacional de Trasplantes
name: Autoridade Para Services de Sangue e Transplantacáo
First posted: 2020-06-04
Enrollment: 230000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Solid organ transplants performed during the study period (kidney, lung, heart, liver and combined organs in Europe (France, Spain, Portugal, Germany, Italy, Croatia, Belgium, Netherlands, Austria), North America (US and Canada), Central and South America (Mexico, Brazil, Uruguay, Argentina and Chile) and Oceania (Australia)

Brief summary: End-stage organ failure is estimated to affect more than 4 to 6 million persons worldwide. In 2018, transplant systems across the globe enabled around 150,000 patients to benefit from a kidney, heart, lung, liver, or other solid organ, a number that was far less than the demand. According to data from the World Health Organization, more than 1,500,000 persons live with a transplanted organ worldwide. In the US, approximately 40,000 patients receive an organ transplant every year, but 120,000 still remain waitlisted for transplantation today, with 7,600 dying annually while waiting for an organ transplant. A similar lack of organs and high death rates on the waiting list affect patients in Europe and many other countries.

As nations adjust to new realities driven by the coronavirus (COVID-19) outbreak, many health care providers, institutions and patients are concerned about the potential impact that COVID-19 will have on organ donation and transplantation. One concern is that transplant recipients may have a greater susceptibility to infection and greater viral burden. A second concern is that hospitals will lack the resources in terms of staff and equipment to care for recipients after transplantation, who often require intensive care and multispecialty management.

Because of the overwhelming healthcare system burden, a dramatic negative effect on worldwide organ donation and transplantation is anticipated, but has not been measured. Our objective was to quantify the worldwide impact of COVID-19 pandemic on organ donation and transplantation and consequences for waitlisted patients.


Eligibility criteria: Inclusion Criteria:

* All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

Exclusion Criteria:

* None

Primary outcomes:
measure: Organ transplantation activity during COVID-19 pandemic
timeFrame: Two years since COVID-19 outbreak.
Secondary outcomes:
measure: Further analysis on organ transplantation with stratification
timeFrame: Two years since COVID-19 outbreak.
Other outcomes:
Locations:
city: Paris
country: France
facility: Paris Transplant Group
Study officials:
affiliation: Paris Translational Research Center for Organ Transplantation
name: Alexandre Loupy
role: PRINCIPAL_INVESTIGATOR
References:
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