COVID-19 Pandemic and Worldwide Organ Procurement

Study Overview
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Brief Summary
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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.

Official Title
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Consequences of the COVID-19 Pandemic on Worldwide Organ Procurement and Transplantation

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| France<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Spain<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Portugal<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Croatia<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Germany<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Italy<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Netherlands<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Austria<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| US<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Canada<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Mexico<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Brazil<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Uruguay<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Argentina<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Chile<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Australia<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Belgium<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |
| Finland<br>All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ transplantation activity during COVID-19 pandemic | Overall deceased donor transplantation performed during the COVID-19 pandemic. Stratified analysis by deceased donor type (Kidney, lung, Liver, heart), and combined transplantations during the COVID-19 pandemic. | Two years since COVID-19 outbreak. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further analysis on organ transplantation with stratification | Geographic disparities related to organ transplantation rates and association with COVID-19 clusters Living donor transplantation performed during the COVID-19 pandemic. Quality of transplanted organs (kidney) before and after the COVID-19 pandemic. Change in relationship between living donors and their recipients before and after the COVID-19 pandemic. | Two years since COVID-19 outbreak. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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organ, procurement, transplantation, pandemic