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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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