Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation

N/AEnrolling By InvitationNCT04234139

Johns Hopkins University300 enrolled

Overview

The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice.

The research study is designed to improve the investigators' understanding of early liver transplantation for patients with severe alcoholic hepatitis. The goal of this research is twofold: 1. Establish a knowledge base necessary for appropriate liver transplant candidate selection by quantifying post-ELT mortality for SAH and compare to outcomes to liver transplantation for other indications 2. Develop an ethical framework for implementation of these transplants for SAH based on the opinions of healthcare providers and the general public.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Liver Diseases, Alcoholic Alcohol-Related Disorders Transplant; Failure, Liver Transplant; Complication, Rejection Liver Diseases Hepatitis, Alcoholic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria for Severe Alcoholic Hepatitis patients: * Patients with Severe Alcoholic Hepatitis (SAH) listed for liver transplantation at Johns Hopkins Hospital (JHH), have not been sober for at least 6 months at time of waitlisting, and are at least 18 years old. Exclusion Criteria for Severe Alcoholic Hepatitis patients: * Non-SAH patients listed for liver transplantation at JHH and patients who have been sober for at least 6 months at the time of waitlisting. Inclusion Criteria for non-SAH comparison group: * Patients 18 years or older undergoing liver transplantation at JHH for alcoholic liver disease and were sober for at least 6 months prior to transplantation. Exclusion Criteria for non-SAH comparison group: * Patients who do not meet inclusion criteria.

Outcomes

Primary Outcomes

Number of participants who survived within 1 year post-transplant

Post-transplant survival within one year of the surgical procedure.

Time frame: 1 years

Secondary Outcomes

Number of participants who self-report or have biochemically measured alcohol recidivism or relapse within 1 year post-transplant

Self-reported or biochemically measured alcohol recidivism or relapse.