Liver Transplantation and Coronavirus Disease 2019 (COVID-19)

NCT04695756 | Unknown DMC

• 1 other identifier: 1405
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19; Liver Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  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

  1 year

Study Arms (1)

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

Interventions

COVID-19 pandemic OTHER

The exposure of this observational study is the COVID-19 pandemic

People who require liver transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 17 years-old
• Argentinean

You may not qualify if:

• none

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• National Agency for Scientific and Technological Promotion, Argentina: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, 1643, Argentina

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Pandemic Preparedness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Disaster Planning; Disasters; Environment; Environment and Public Health; Communicable Disease Control; Public Health Practice; Public Health

Study Officials

• Sebastián Marciano, MS, Msc

  Hospital Italiano de Buenos Aires

  STUDY CHAIR

Central Study Contacts

Sebastián Marciano, MD, MSc

CONTACT

01150066086; sebastian.marciano@hospitalitaliano.org.ar

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the non-sponsored area of the departemt of Research

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 5, 2021
• Study Start: December 15, 2020
• Primary Completion: June 15, 2021
• Study Completion: July 15, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)