ACUTE LIVER FAILURE STUDY GROUP

Acute Liver Failure (ALF) is such a rare disease, a group of university hospitals are collecting information and blood samples to improve understanding and discover better ways of caring for ALF patients.  The Acute Liver Failure Study Group consists of 28 adult centers and 24 pediatric centers, with headquarters at the University of Texas Southwestern Medical Center at Dallas.

The group addresses a definite need:  lack of significant research in Acute Liver Failure in the United States.  With approximately 2000 cases per year, no one medical center sees enough cases to collect much information on this disease.  The multi-center clinical trial group is now established, providing abundant clinical data and samples for analysis, and the means to conduct a therapy study.

This program is funded by the National Institutes of Health (NIH) in Bethesda, Maryland, and the Food and Drug Administration (FDA) in Rockville, Maryland.

A Multi-Center Trial to Study Acute Liver Failure:  Data and Specimen Collection Protocol - ALF Study

The ALF Study Group is collecting information on the natural history, causes and outcomes of Acute Liver Failure in the United States.  Information from the patient's hospital records, as well as blood and tissue samples, when available, are used to study this condition.  Spin-off studies will include an expanded effort to discover new viruses that cause liver failure, and the development of a more detailed registry to identify cases of liver failure due to drug overdoses.

All information obtained in the data and specimen collection is held in strict confidence, and no participation in the study is possible without informed consent from the patient, relatives, or the person closest to the patient.  No names are used at any time in this study, so the information is truly confidential.  With this information, doctors and scientists will have a more complete picture of the disease and its causes, so that new treatments, for this rare and very serious condition, can be found.

A Multi-Center Study of the Safety and Efficacy of N-acetylcysteine (NAC) in the Treatment of Acute Liver Failure Not Caused by Acetaminophen - NAC Study

With a death rate for Acute Liver Failure around 80%, there is no accepted treatment for this critical illness.  In some cases, liver transplantation may be performed.  The main purpose of this study is to test whether a drug called N-acetylcysteine (NAC) improves outcome (survival) for patients with Acute Liver Failure not caused by acetaminophen overdose.  The ALF Study Group aims to provide a comprehensive approach to the study of Acute Liver Failure, and to improve significantly the outcomes of patients in the United States with this life-threatening illness.

Once consent is obtained from the next of kin, the patient will be chosen at random to receive either a NAC solution of sugar water intraveinously,  or sugar water solution alone (control group).  Therefore, half the patients receive the NAC, and the other half the sugar water.  This procedure will start as soon as possible after admission, and run for 72 hours.  Since the choice of solution is made at random, neither the investigator, the patient, nor their family will know which treatment is being given.  Once the study is concluded, the group of subjects who received the NAC will be compared to the control group, in regard to length of time in intensive care, time with altered mental functioning, and survival.  This will determine the benefits of this procedure.

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