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临床试验/NCT00986648
NCT00986648已完成不适用

A Multi-Center Group to Study Acute Liver Failure in Children

University of Pittsburgh20 个研究点 分布在 3 个国家目标入组 158 人开始时间: 2000年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
158
试验地点
20

研究概览

简要总结

The PALF study group began with 20 sites and now continues with 12 sites (11 in the United States and 1 in Canada) in the new funding period. The primary objective of the Pediatric Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with ALF, including information derived from biospecimens.

详细描述

The PALF study group will collect clinical, epidemiological and outcome data on children with ALF. This information will be used to develop methods to predict whether a child will recover from the illness without the need for a liver transplant or other life-saving procedure. We believe the methods to predict survival will vary with different patient age groups, but that diagnosis, multi-system organ failure, degree of encephalopathy and level of coagulopathy will be important regardless of patient age. Biological samples, such as blood and liver tissue, will provide opportunities to identify subgroups of patients who have unique treatment requirements and outcomes. In addition, we hope to identify unrecognized mechanisms of liver injury resulting in ALF in children. Eligible study participants will be invited to participate in neurocognitive testing. Since patients that develop acute liver failure experience varying levels of hepatic encephalopathy and cerebral edema, we suspect that there may be residual sub-clinical neurological injury that compromises long-term neurocognitive function. Detailed neurocognitive testing has never been performed in a cohort of children that survive acute liver failure and this study seeks to close that information gap by defining the spectrum of neurocognitive outcomes in this population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent/assent
  • Birth through 17 years of age
  • Biochemical evidence of acute liver injury
  • Coagulopathy not corrected by vitamin K (or other intervention intended to correct coagulopathy)
  • The presence of encephalopathy (ENC) is required if the INR is at least 1.5 and less than 2.0
  • If INR is at least 2.0, the presence of ENC is not required

排除标准

  • Known chronic underlying liver disease
  • Multi-organ system failure following heart surgery or ECMO
  • Solid organ or bone marrow transplantation
  • Acute trauma
  • Previously enrolled in the PALF Cohort Study
  • Other severe illness, condition, or other reason in the opinion of the investigator that would make the patient unsuitable for the study

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

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