Clinical trial NCT04234139: Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation
Official title: Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Diseases, Alcoholic
Alcohol-Related Disorders
Transplant; Failure, Liver
Transplant; Complication, Rejection
Liver Diseases
Hepatitis, Alcoholic
Alcohol-Induced Disorders
Keywords: liver transplant
alcoholic liver disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-01-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe Alcoholic Hepatitis patients listed for liver transplatation at Johns Hopkins Hospital and patients undergoing liver transplantation at Johns Hopkins Hospital for Alcoholic Liver Disease

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.

Eligibility 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.

Primary outcomes:
measure: Number of participants who survived within 1 year post-transplant
timeFrame: 1 years
Secondary outcomes:
measure: Number of participants who self-report or have biochemically measured alcohol recidivism or relapse within 1 year post-transplant
timeFrame: 1 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Andrew M Cameron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee BP, Chen PH, Haugen C, Hernaez R, Gurakar A, Philosophe B, Dagher N, Moore SA, Li Z, Cameron AM. Three-year Results of a Pilot Program in Early Liver Transplantation for Severe Alcoholic Hepatitis. Ann Surg. 2017 Jan;265(1):20-29. doi: 10.1097/SLA.0000000000001831.
citation: Weeks SR, Sun Z, McCaul ME, Zhu H, Anders RA, Philosophe B, Ottmann SE, Garonzik Wang JM, Gurakar AO, Cameron AM. Liver Transplantation for Severe Alcoholic Hepatitis, Updated Lessons from the World's Largest Series. J Am Coll Surg. 2018 Apr;226(4):549-557. doi: 10.1016/j.jamcollsurg.2017.12.044. Epub 2018 Feb 2.