Welcome to the website of the Acute Liver Failure Study Group (ALFSG). ALFSG was founded at UT Southwestern Medical Center in 1997, with the principal aim to develop a consortium of investigators in the United States with interest and expertise in acute liver failure (ALF) to study this rare, orphan condition. Now in our 15th year, ALFSG has received funding largely from the National Institutes of Health, but also from the Food and Drug Administration, and from private donors and foundations in support of our work. It is estimated that there are only about 2,000 such cases of acute liver failure in the United States annually. Thus, a network of clinical centers was considered essential to allow for a critical mass of data and bio-samples to be accrued in a timely fashion. Despite its rarity, ALF continues to get attention because these relatively few patients have dramatic and sometimes devastating disease presentations, frequent need for liver transplantation, and high resource utilization.
The Acute Liver Failure Study Group initially consisted of 14 academic sites around the United States, then expanded to 23 and, after our last competitive renewal, narrowed to the current 13 sites, all tertiary-care liver transplant centers. The administrative offices are at UT Southwestern Medical Center at Dallas and the Data Coordinating Center at the Medical University of South Carolina. A pediatric counterpart, the Pediatric Acute Liver Failure Group (PALF), began at UT Southwestern and is now based at the University of Pittsburgh under the leadership of Robert Squires, Jr., M.D.
Principal Investigator: William M. Lee, M.D.
William M. Lee, M.D., obtained his bachelor's degree from Amherst College and his medical degree from Columbia University College of Physicians and Surgeons. He completed residency training in Internal Medicine at the Presbyterian Hospital in New York City (Columbia-Presbyterian Medical Center) and served as Chief Resident there. He was Honorary Registrar and Research Fellow to Roger Williams, M.D., at the Liver Unit, Kings College Hospital, London, from 1973-1974. He was on the faculty of Columbia University College of Physicians and Surgeons and the Medical University of South Carolina before coming to UT Southwestern in 1990. He has been active in clinical research in the field of viral hepatitis and drug-induced liver injury. He has been site investigator for 4 Networks sponsored by the National Institute of Diabetes, Digestive and Kidney Diseases: the HALT-C Trial, the Acute Liver Failure Study Group, the Drug-Induced Liver Injury Network and the Hepatitis B Research Network.
History of the Acute Liver Failure Study Group (ALFSG)
The ALFSG began in 1998 and has been funded ever since by generous support from NIDDK, currently as a U-01 Clinical Network, to collect detailed demographic, clinical and biochemical information on patients enrolled who met two salient criteria for acute liver failure: encephalopathy and coagulopathy as sequelae of an acute illness. It is estimated that there are only about 2,000 such cases in the United States annually. Thus, a network of clinical centers was considered essential to allow for a critical mass of data and bio-samples to be accrued in a timely fashion. The group began with 14 sites, later expanded to 23 sites, and now has downsized to 13 sites that continue to enroll about 150 patients into the registry each year that meet the above criteria. Since 2007, a new group of patients has also been enrolled in a separate category, those with acute liver injury (ALI), defined as having severe hepatocyte injury as indicated by an INR of 2.0 and AST of 10x ULN but with no evidence of encephalopathy.
As of September 14, 2012, enrollment in the ALF study stands at 1,967 and in the ALI study at 304.
The goal of ALFSG from the beginning has been to collect detailed prospective data on patients having this rare condition. The essential features are: a short-term hepatic illness with coagulopathy (abnormal blood clotting) characterized by a prothrombin time/INR of ≥1.5 and any degree of hepatic encephalopathy (mental changes associated with liver failure). In addition to the clinical history and physical findings as well as hospital course and short- and long-term outcomes, the investigators collect serum samples, plasma, urine, and DNA, as well as liver tissue where available. The bio-samples repository contains more than 75,000 specimens. The Pediatric Acute Liver Failure Study (PALF) has to date enrolled nearly 1,000 patients with similar criteria.
Because patients are by definition having mental slowing or coma, informed consent is obtained from next of kin in all cases. All information obtained is held in strict confidence, and no participation in the study is possible without informed consent. No names are used at any time in this study, so the information is truly confidential. If information about you or your loved one's illness is sent to the group, 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.
Physicians wishing to refer patients with acute liver failure, or having questions regarding this condition, contact one of the site investigators.