Acute Liver Failure Study Group: Adult Acute Liver Failure Study (AALF)

General Description

Acute liver failure (ALF) affects about 2,000 persons per year in the U.S. Patients with ALF show severe and sometimes devastating disease presentations and require extensive care and resources. Liver transplant is often necessitated as treatment. The Acute Liver Failure Study Group (ALFSG) was established in 1997 to develop a consortium of investigators and clinical centers that could consolidate data and biospecimens for observational and clinical trials concerning ALF.

A Multi-Center Trial to Study Acute Liver Failure in Adults (AALF) is a prospective cohort study currently being conducted by the ALFSG. The study is designed to collect clinical and epidemiological data as well as serum, plasma, urine, tissue and DNA samples on individuals who have ALF and on individuals who have acute liver injury (ALI), a less severe group of patients who have coagulopathy but do not reach the threshold of encephalopathy. Patients with either ALF or ALI who meet the eligibility criteria are enrolled and referred to ALFSG clinical sites by providers. Information concerning clinical history and physical findings, hospital course, and short- and long-term outcomes are collected for all participants who consent to participate in the study. Patients are followed long-term at 6 and 12 months. Overall survival and outcome data will be assessed to contribute to the understanding of these conditions. Currently, the bioreposity contains more than 75,000 specimens for over 2,000 patients.

This study is ongoing.

Objectives

The primary objectives of the study are to collect clinical and epidemiological data as well as biospecimens (serum, plasma, urine, tissue, DNA samples) on individuals who have acute liver failure and on individuals who have acute liver injury, a less severe group of patients who have coagulopathy but do not reach the threshold of encephalopathy.

Criteria

Eligibility criteria for patients with ALF include:
- Altered mentation of any degree (encephalopathy)
- Evidence of moderately severe coagulopathy (INR ≥ 1.5)
- Presumed acute illness onset of less than 26 weeks
- Informed consent from patient’s next of kin

Eligibility criteria for patients with ALI include:
- Acetaminophen (APAP) etiology of acute illness < 2 weeks
- INR ≥ 2.0, ALT ≥ 10X ULN, and non-acetaminophen etiology of acute illness < 26 weeks
- INR ≥ 2.0, ALT ≥ 10X ULN, and TBili ≥ 3 mg/dl

Outcome

This study is ongoing.