Liver Transplantation and Coronavirus Disease 2019 (COVID-19)

Impact of Coronavirus Disease 2019 (COVID-19) Epidemic in Patients Requiring Liver Transplantation

The COVID-19 pandemic together with the strategies that are applied to control it are generating high morbidity and mortality worldwide. Its impact on health systems is worrisome, affecting all the population, even those who are not infected or at risk.

The indirect impact of the COVID-19 pandemic on the access to the medical care of patients on the waiting list for organ transplantation might be multifactorial, including the need to relocate health-related resources (medical personnel, supplies, critical care unit beds, etc), the risk of COVID-19 transmission among donors or patients on the waiting list, and also after transplantation. Additionally, the pandemic reduces significantly the donor pool.

We consider that it is important to assess the impact that the pandemic has in particular individual populations, such as in patients requiring a liver transplant. Along with the lockdown, the rate of organ donation has dropped, and liver transplant programs across the world have reduced or suspended their activity. Unfortunately, this is invariably associated with an increase in mortality on the waiting list.

Knowing the impact of the pandemic on patients who require a liver transplant will provide tools to understand and plan the health resources related to the care of these patients, not only at present but also in the following years.

Study Overview

• Status: Unknown
• Conditions: Covid19; Liver Transplant
• Intervention / Treatment: Other: COVID-19 pandemic

Detailed Description

The COVID-19 pandemic together with the strategies that are applied to control it is generating high morbidity and mortality worldwide. Its impact on health systems is worrisome, affecting all the population, even those who are not infected or at risk.

The indirect impact of the COVID-19 pandemic on the access to the medical care of patients on the waiting list for organ transplantation might be multifactorial, including the need to relocate health-related resources (medical personnel, supplies, critical care unit beds, etc), the risk of COVID-19 transmission among donors or patients on the waiting list, and also after transplantation. Additionally, the pandemic reduces significantly the donor pool.

We consider that it is important to assess the impact that the pandemic has in particular individual populations, such as in patients requiring a liver transplant. Along with the lockdown, the rate of organ donation has dropped, and liver transplant programs across the world have reduced or suspended their activity. Unfortunately, this is invariably associated with an increase in mortality on the waiting list.

Knowing the impact of the pandemic on patients who require a liver transplant will provide tools to understand and plan the health resources related to the care of these patients, not only at present but also in the following years.

The primary objectives of the study will be

To Compare the following outcomes in patients requiring liver transplantation during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation:

1. Number of patients registered on the liver transplant waiting list
2. Number of deaths on the liver transplant waiting list
3. Number of liver transplants

For this purpose, we will carry out a time series analyses using the national data registry of procurement and transplantation database. The effect of both periods will be analysed as time interrupted series, which is a quasi-experimental design. The following two periods will be compared as segments of the interrupted time series:

• Baseline period (Period not exposed to the pandemic represented by the same epidemiological weeks of 2019 )
• Pandemic period COVID-19. (Period between the epidemiological weeks of 2020 affected by the pandemic declared by the WHO from 11/March/2020)

The unit of analysis will be the epidemiological weeks, and the study population will be all Argentinian over 17 years of age. Regarding patients who require liver transplantation, those who registered for isolated liver transplantation in the National Procurement and Transplant Institute will be included.

A Poisson regression model will be used to assess the association between the period and the incidence of the events of interest. ARIMA models will be used following the 4 steps proposed by Box and Jenkings

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1643
    • Recruiting
    • Hospital Italiano de Buenos Aires
    • Contact: Sebastián Marciano, MD, MsC; Phone Number: 1150066086; Email: sebastian.marciano@hospitalitaliano.org.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This is a population-based study. The study population is the Argentine population.

Regarding the patients, those who are registered on the national waiting list for isolated liver transplantation will be included.

Description

Inclusion Criteria:

• Age > 17 years-old
• Argentinean

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People who require liver transplant; We will compare the year before the beginning of the COVID-19 Pandemia with the period during the COVID-19 Pandemia.	Other: COVID-19 pandemic; The exposure of this observational study is the COVID-19 pandemic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the number of patients registered on the liver transplant waiting list during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation	During the study period, patients who are registered on the transplant waiting list will be included. The data source will be the national transplant database.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the number of deaths on the liver transplant waiting list during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation	During the study period, patients who die on the transplant waiting list will be registered. The data source will be the national transplant database.	1 year
To compare the number of liver transplants during the epidemiological weeks of COVID-19 pandemic in Argentina and the same weeks of 2019 according to national data registry of procurement and transplantation	During the study period, the number of liver transplants who are performed will be registered. The data source will be the national transplant database.	1 year

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires
• Collaborators: National Agency for Scientific and Technological Promotion, Argentina
• Investigators: Study Chair: Sebastián Marciano, MS, Msc, Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Anticipated): June 15, 2021
• Study Completion (Anticipated): July 15, 2021

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 1405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No