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

• Conditions: Transplant; Complication, Rejection; Liver Diseases, Alcoholic; Hepatitis, Alcoholic; Liver Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Transplant; Failure, Liver
• Interventions: Procedure: liver transplant

• Registration Number: NCT04234139
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-21
• Study Start: 2020-04-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Cohort 2	liver transplant	Orthotopic Liver Transplantation (OLT) in patient who present with Alcoholic Liver Disease (ALD)
Prospective Cohort 1	liver transplant	Early Liver Transplantation (ELT) for patients who present with Severe Alcoholic Hepatitis (SAH)
Retrospective Cohort	liver transplant	Early Liver Transplantation (ELT) for patients who presented with Severe Alcoholic Hepatitis (SAH)

Primary Outcome Measures

Name	Time	Method
Number of participants who survived within 1 year post-transplant	1 years	Post-transplant survival within one year of the surgical procedure.

Secondary Outcome Measures

Name	Time	Method
Number of participants who self-report or have biochemically measured alcohol recidivism or relapse within 1 year post-transplant	1 years	Self-reported or biochemically measured alcohol recidivism or relapse.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States