A Multi-Center Group to Study Acute Liver Failure

Study ID
STU 062010-126

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • Zale Lipshy University Hospital
  • Parkland Health & Hospital System

Angela Bowling

Principal Investigator
William Lee, M.D.


The primary objective of the present proposal is the collection of prospective clinical and laboratory data for all acute liver failure or acute liver injury patients seen in Parkland or university Hospitals. Timely collection of serum samples will be undertaken. Blood samples (about two tablespoons) are collected at the time of routine phlebotomy for up to 7 days once the patient is enrolled. in addition, a one-time collection of urine is obtained to be used in future ancillary studies. Further, a single sample of blood (1 tablespoon) for Dna extraction purposes will be
collected if possible. Dna contained within this sample will be separated and stored for future genetic tests related to acute liver failure. Collected samples are de-indentified. Since, in many instances, the cause of the liver damage is not known, these samples will allow researchers to determine whether viruses or poisons of some kind have affected the liver leading to its failure to function. Data will be deindentified and will be gathered on an electronic data capture system at the Data Coordinating unit at the Medical university of South Carolina for later analysis. Further, if an aLi patient develops aLF (i.e. experiences alteration in their mental status) then the biospecimen
collection and data collection will be done in accordance with the portion of the protocol pertaining to patients with aLF. no more than 14 days of daily biospecimen will be undertaken, even under a combined aLi and aLF biospecimen data collection schedule.For follow-up visits, patients will be contacted by study personnel at day 21 and 6 and 12 months post-enrollment either in person or via telephone. Clinical
and demographic information will be collected from consenting subjects. Subjects will be asked to complete two self-administered quality of life forms (SF-36 and CDC-14) and undergo a brief battery of neuropsychiatric tests (RBanS and Trails a/B) at each the study visit at the 6 and 12 months follow-up visits. a comprehensive lab profile (liver function test, electrolytes), CBC with platelets and inR will be done or clinical data obtain from the medical chart. in addition two 10ml tubes for blood for serum aliquoting for research purposes will be requested
from each patient. Patients enrolled in the study who are diagnosed with an acetaminophen overdose will be asked to complete a separate questionnaire for information that includes: prior awareness of acetaminophen toxicity, previous overdoses, depression and impulsivity data.
every intentional/suicidal acetaminophen overdose patient automatically receives a psychiatric consult as part of their standard of care and must be cleared for discharge by the psychiatric team. a psychiatric consult will also be made for any unintentional acetaminophen overdose patient who is found to be clinically depressed and/or suicidal.

Participant Eligibility

Inclusion Criteria for Acute Liver Failure (ALF) Registry:
1) Between 18 and 70 years of age
2) Hepatic illness or jaundice <= 26 weeks
3) Encephalopathy
4) Coagulopathy (INR >=1.5)

A separate category of patients may also be enrolled that have Acute Liver Injury (ALI) and meet the following criteria:
1) Hospitalized patient
2) If presumed acetaminophen etiology: acute hepatic illness < 2 weeks, with INR >= 2.0, alanine aminotransferase (ALT) of >= 10X ULN.
3) If presumed non-acetaminophen etiology: acute hepatic illness of < 26 weeks, with INR >= 2.0, ALT of >= 10X ULN, total bilirubin of >= 3.0 mg/dL.