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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 Develop an ethical framework for implementation of these transplants for SAH based on the opinions of healthcare providers and the general public.

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

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

Intervention / Treatment
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* Procedure: liver transplant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Retrospective Cohort<br>Early Liver Transplantation (ELT) for patients who presented with Severe Alcoholic Hepatitis (SAH) | Procedure: liver transplant<br>* solid organ transplant<br>|
| Prospective Cohort 1<br>Early Liver Transplantation (ELT) for patients who present with Severe Alcoholic Hepatitis (SAH) | Procedure: liver transplant<br>* solid organ transplant<br>|
| Prospective Cohort 2<br>Orthotopic Liver Transplantation (OLT) in patient who present with Alcoholic Liver Disease (ALD) | Procedure: liver transplant<br>* solid organ transplant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who survived within 1 year post-transplant | Post-transplant survival within one year of the surgical procedure. | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver transplant, alcoholic liver disease