Observational Study of Children Acute Liver Failure in North America (Cohort Study)

Study ID
STU 022011-095

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Margaret Cowie
214-456-1865
margaret.cowie@childrens.com

Principal Investigator
Norberto Rodriguez-Baez

Summary

1.3. Summary

We propose trans-disciplinary collaboration to ensure a structured diagnostic and management strategy, to monitor clinical, biochemical, and physiological parameters, and to collect markers of the immune and inflammatory milieu, neurological injury and liver regeneration. We will associate these parameters with survival and neurocognitive outcomes. To accomplish these tasks requires a strong infrastructure for multi-center, patient-based research, clinical expertise and translational expertise related to our emerging understanding of the pathobiology of PaLF. if successful, this approach will change the paradigm of research and patient management in PaLF by: 1) improving mechanistic understanding of etiology, progression, and prognosis 2) identifying sub-cohorts amenable to directed therapy.

Participant Eligibility

Inclusion criteria

* Written informed consent/assent

* Birth through 17 years of age

* Biochemical evidence of acute liver injury at the time of enrollment

* Coagulopathy not corrected by vitamin K (or other intervention intended to correct coagulopathy)
oThe presence of encephalopathy (ENC) is required if the INR is at least 1.5 and less than 2.0
o If INR is at least 2.0, the presence of ENC is not required