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