? The Acute Liver Failure Study Group (ALFSG) goals are to advance knowledge and understanding of ? acute liver failure through a multi-center approach including data, serum and DNA collection, and a ? therapeutic trial of N-acetylcysteine (NAC) for non-acetaminophen acute liver failure. At the beginning ? the third year of this grant, several specific additional funding needs have been identified. The purpose ? of this competing supplement is to request increased funding for an expanded scope of work, specifically in 3 areas: 1) Twelve additional sites have been added to the study group in order to fulfill the group's main goal, the completion of the N-acetylcysteine trial. The original plan called for 15 adult sites; we now have 27 sites participating, necessitated by the slower than expected enrollment in the therapy trial. The administrative costs required to support the additional sites are requested, to ensure the trial's completion. 2) A long-term follow-up study and the acquisition of DNA samples in addition of sera have been added to the original data and serum registry. The original study had no provision for study of patient outcomes past their initial hospitalization. DNA samples had not originally been ? anticipated but provide a valuable resource for future investigations. 3) Funding is requested for several ? ancillary studies not anticipated at the time of the original grant, all targeted toward a better understanding of the pathogenesis of ALF. These include 1) analysis of the role of apoptotic markers, 2) study of the role of heavy metals and reactive oxygen species, and 3) a study of acetaminophen adducts as markers of liver injury due to acetaminophen toxicity. To date, several ancillary studies have been accomplished within the current grant budget. These three ancillary studies require additional support beyond that anticipated in the original grant submission. To seize the opportunities now present, we request additional funding in 3 areas: central site resources for full implementation of the NAC trial and DNA sample handling, the long-term follow-up study and to fully utilize the rich clinical material available for ancillary studies closely related to acute liver failure. ? ?
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