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

Johns Hopkins University

Status: Invitation-only

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

Treatments: Procedure: liver transplant

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04234139

P50AA027054 (U.S. NIH Grant/Contract)

IRB00154881

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

300 participants in 3 patient groups

Retrospective Cohort

Description:

Early Liver Transplantation (ELT) for patients who presented with Severe Alcoholic Hepatitis (SAH)

Treatment:

Procedure: liver transplant

Prospective Cohort 1

Description:

Early Liver Transplantation (ELT) for patients who present with Severe Alcoholic Hepatitis (SAH)

Treatment:

Procedure: liver transplant

Prospective Cohort 2

Description:

Orthotopic Liver Transplantation (OLT) in patient who present with Alcoholic Liver Disease (ALD)

Treatment:

Procedure: liver transplant