A Multi-Center Group to Study Acute Liver Failure

研究急性肝衰竭的多中心小组

• 批准号: 9145659
• 负责人: VALERIE L DURKALSKI
• 金额: $ 341.54万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9145659
• 关键词: Acetaminophen; Acetylcysteine; Acute Liver Failure; Address; Admission activity; Adult; Affect; American; Ammonia; Ancillary Study; Artificial Liver; Autoimmune Hepatitis; Biological; Biological Assay; Biometry; Blood Banks; Blood Coagulation Disorders; Blood Coagulation Factor; Brain Edema; Breath Tests; Cerebral Edema; Clinical; Clinical Data; Clinical Research; Clinical Trials; Coagulation Process; Collaborations; Complex; Conduct Clinical Trials; Data; Data Collection; Data Coordinating Center; Databases; Devices; Diagnostic; Disease Outcome; Disease susceptibility; Encephalopathies; Enrollment; Equilibrium; Etiology; Evaluation; Genomics; Goals; Grant; Health; Hemorrhage; Hemostatic Agents; Hemostatic function; Hepatic; Hepatic Mass; Hepatitis A; Hepatitis B; Hepatocyte; High Pressure Liquid Chromatography; Hyperammonemia; Knowledge; Lead; Leadership; Learning; Liver; Liver diseases; Measures; National Institute of Diabetes and Digestive and Kidney Diseases; Natural regeneration; Observational Study; Online Systems; Ornithine; Orphan; Outcome; Pathogenesis; Patients; Pattern; Pharmaceutical Preparations; Phase; Phenylacetates; Randomized; Registries; Research; Research Personnel; Resources; Role; Safety; Sampling; Site; Source; Structure; System; Testing; Transplantation; United Network for Organ Sharing; United States; Viral; Virus; Work; acute liver injury; adduct; adjudication; base; clinical care; control trial; cost; cytokine; data management; efficacy testing; efficacy trial; electronic data; improved; indexing; insight; killings; liver function; liver injury; liver transplantation; novel therapeutics; outcome forecast; patient safety; point of care; prevent; prognostic; repository; response; survival prediction; tool; trend

 DESCRIPTION (provided by applicant): Since 1998, the Acute Liver Failure Study Group (ALFSG) has provided a network of sites across the United States, dedicated to learning and disseminating new knowledge about acute liver failure, a super-orphan condition that frequently kills young people and involves high resource utilization, despite its rarity. Few, if any, treatments have become available to preserve liver function and avoid the dire consequences of the sudden loss of hepatocyte mass. ALFSG has collected and disseminated important clinical information and bio-samples on more than 2,500 patients and conducted a controlled trial of N-acetylcysteine and a safety trial of ornithine phenylacetate (OPA) as putative treatment options. In addition, ALFSG has provided new insights into the central role of acetaminophen (APAP) in ALF in United States patients and further characterized many of the other etiologies such as hepatitis A, hepatitis B, autoimmune hepatitis and ischemic liver disease as well as focusing on disease outcomes and the role of transplantation. More than 90 ancillary studies have been initiated utilizing our data and bio- samples, generating ~70 original articles on all aspects of ALF. With our realignment of sites in 2010 and subsequent addition of 4 more sites, enrollment has increased, and this will facilitate more rapid completion of forthcoming trials. The correct assessment of etiology and prognosis on admission are vital to the management of ALF. Our new initiatives are directed at strengthening our diagnostic and prognostic assessments with further testing via point-of-care assays: the acetaminophen adduct assay, a dynamic measure of hepatic mass (methacetin breath test), evaluation of the role of coagulation factors in the condition (utilizing the ROTEM thromboelastogram), and finally testing the efficacy of OPA as an ammonia-trapping agent to ameliorate encephalopathy and brain edema. Additional approaches will include careful analyses of causality, fine tuning of prognostic assessments and, possibly, and the possible introduction of a liver support machine in the latter part of the grant cycle. Continuing studies of genomics, cytokines, coagulation and hepatic regeneration, compliment the clinical work and continue to make ALFSG a landmark research network and resource for other investigators.

 描述（由适用提供）：自1998年以来，急性肝衰竭研究小组（ALFSG）提供了整个美国的网站网络，致力于学习和传播有关急性肝衰竭的新知识，这是一种经常杀死年轻人并涉及高资源利用的超级孔状况，涉及高级资源，Dospite稀有。很少有（如果有的话）可以使用以保护肝功能，并避免肝细胞质量突然丧失的可怕后果。 ALFSG已针对2500多名患者收集并传播了重要的临床信息和生物样本，并进行了N-乙酰半胱氨酸的对照试验，并进行了鸟氨酸苯乙酸酯（OPA）作为推测治疗方案的安全试验。此外，ALFSG为美国患者的ALF提供了对乙酰氨基酚（APAP）的核心作用的新见解，并进一步表征了许多其他病因，例如丙型肝炎，乙型肝炎，乙型肝炎，自身免疫性肝炎和缺血性肝病，并着重于疾病和疾病的作用。使用我们的数据和生物样本启动了90多个辅助研究，在ALF的所有方面生成了约70篇原始文章。随着我们在2010年重新调整站点，随后增加了4个站点，入学人数增加了，这将有助于更快地完成即将进行的试验。对病因和预后的正确评估对于ALF的管理至关重要。 Our new initiatives are directed at strengthening our diagnostic and prognostic assessments with further testing via point-of-care assays: the acetaminophen adduct assay, a dynamic measurement of hepatitic mass (methacetin breath test), evaluation of the role of coagulation factors in the condition (utilizing the ROTEM thromboelastogram), and finally testing the Efficacy of OPA as an ammonia-trapping agent to改善脑病和大脑水肿。其他方法将包括对休闲性的仔细分析，预后评估的微调以及在赠款周期后期可能引入肝支撑机。继续研究基因组学，细胞因子，凝结和肝脏再生，称赞临床工作，并继续使ALFSG成为其他研究人员的具有里程碑意义的研究网络和资源。