A Multi-Center Trial to Study Acute Liver Failure in Adults

The purpose of this study is to collect clinical and epidemiological data as well as serum,
plasma, urine, tissue and 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.

Eligibility Criteria

ALF Inclusion Criteria:

- Written Informed consent from patient's next of kin

- Altered mentation of any degree (encephalopathy)

- Evidence of moderately severe coagulopathy (INR ≥ 1.5)

- A presumed acute illness onset of less than 26 weeks

- The NIH guidelines on the inclusion of women and minorities as subjects in clinical
research will be observed

ALF Exclusion Criteria:

- Cirrhosis patients

- Alcohol induced liver failure

- Known pre-existing chronic liver disease

ALI Inclusion Criteria:

Acetaminophen (APAP) etiology: acute illness < 2 wks

- INR ≥ 2.0, ALT ≥ 10X ULN Non-acetaminophen etiology: acute illness < 26 wks

- INR≥ 2.0, ALT≥ 10X ULN, TBili ≥ 3 mg/dl

ALI Exclusion Criteria:

- Altered mentation of any degree (encephalopathy)

Principal Investigator

Jody Olson

Study Contact

William M Lee, MD, william.lee@utsouthwestern.edu, 214-645-6111

Estimated Completion Date

Wednesday, August 1, 2018

ClinicalTrials.gov #

NCT00518440
06/18/2015