# Project 1-Cohort and Ethical Analysis of Patients undergoing Early Liver Transplant for Severe Alcoholic Hepatitis

> **NIH NIH P50** · JOHNS HOPKINS UNIVERSITY · 2020 · $440,531

## Abstract

Project Summary
Alcoholic liver disease (ALD) accounts for 26% of liver transplants (LTs) performed annually in the United
States. Given concerns of post-transplant recidivism and the possibility for pre-transplant clinical improvement
with abstinence, most centers require 6 months of documented sobriety prior to LT. However, a subset of
patients present with severe alcoholic hepatitis (SAH) refractory to aggressive steroid-based treatment. For
these incredibly sick patients, 3-month mortality is 70-80% without LT, precluding the possibility of a 6-month
sobriety rule. Early LT (ELT) is the only life-saving treatment available for these patients, however, it
remains rare and controversial, because at most centers the standard 6-month sobriety period is a
transplant candidacy requirement.
 Although few transplant centers worldwide perform ELT for SAH, several groups have shown excellent
short-term survival and comparable recidivism rates. We recently conducted a pilot study, the largest cohort of
ELT recipients for SAH, which demonstrated excellent overall survival rates and similar post-LT recidivism
rates to those undergoing LT for ALD with >6 months of sobriety. We have established the DELTA Center
(Delivery of Early Liver Transplant for Alcoholic Hepatitis) at JHU as a specialized alcohol research center to
oversee this work moving forward.
 The survival benefit of ELT in appropriately selected SAH candidates must be quantified and support
from the public and transplant community must be gained in order to advance ELT for SAH. In order to
establish the knowledge base necessary for appropriate candidate selection, develop a clinical understanding
of ELT for SAH, and identify the public’s opinion regarding this practice, we propose: 1) To quantify post-ELT
mortality for SAH and compare outcomes to LT for other indications; 2) To quantify the survival benefit of ELT
for SAH; and 3) To create an ethical framework for considering ELT for SAH based on the opinions of SAH
patients, transplant providers, and the general public about this practice, thus resulting in a new rational
national policy on ELT for SAH.
 This study will represent the largest prospective cohort study of LT for SAH in the world. Our
findings will have an immediate and direct impact on the practice of ELT for SAH in the United States,
informing critical aspects of candidate selection, informed consent, post-LT care and national policy. Robust
quantification of the risk and survival benefit associated with ELT for SAH is novel and necessary to expand
the practice within the ethical constraints and concerns of the transplant community. A better understanding of
this emerging treatment is essential for improving care of patients with SAH and will help improve the
feasibility, availability and quality of ELT for SAH potentially providing novel, lifesaving treatment for patients
with SAH in the United States.

## Key facts

- **NIH application ID:** 9852405
- **Project number:** 5P50AA027054-02
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** ANDREW M. CAMERON
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $440,531
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9852405

## Citation

> US National Institutes of Health, RePORTER application 9852405, Project 1-Cohort and Ethical Analysis of Patients undergoing Early Liver Transplant for Severe Alcoholic Hepatitis (5P50AA027054-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9852405. Licensed CC0.

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