Pediatric Acute Liver Failure (PALF)
Number of Subjects in Study Archive: 300
Study Design: Observational
Conditions: Liver Diseases, Liver Failure, Acute
Duration: January 2000 - August 2015
# Recruitment Centers: 12
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT00986648
Acute liver failure (ALF) is a condition in which liver function rapidly deteriorates. ALF often affects young people and causes serious, and sometimes fatal, complications. Treatment of the disease is dependent upon its cause, which can be numerous factors. Because recovery from this disease is random, there is no way to predict how a patient will respond to treatment. Sometimes a liver transplant is required in order for a patient to make a full recovery. The mission of the Pediatric Acute Liver Failure (PALF) study is to develop methods to predict whether a child will require a life-saving procedure in order to recover from the illness.
Clinical, epidemiological, and outcome data on PALF patients will be collected and analyzed. The study group will also use the data to identify unrecognized mechanisms of liver injury that cause PALF. Acute liver failure leads to hepatic encephalopathy and cerebral edema, so patients will be invited to participate in neurocognitive testing to determine whether long-term neurocognitive function has been compromised. The prediction methods will vary and be influenced by age, diagnosis, multi-system organ failure, degree of encephalopathy, and coagulopathy level.
The objective of the PALF study is to gather information on children with acute liver failure (ALF). The data will be used to develop methods to predict whether a child will require a life-saving procedure in order to recover from the illness.
Primary Outcome Measure:
Biospecimens and various data on children with acute liver failure will be collected and analyzed.
Secondary Outcome Measure:
The outcome of the neurocognitive testing will be evaluated.
Participants of this study must be age 17 or younger; have diagnosed acute liver injury; and have untreated coagulopathy.
Individuals will be excluded from the study if they have chronic liver disease; are an organ or bone marrow transplant recipient; experienced multi-organ system failure after heart surgery or ECMO; or suffered acute trauma.
This study is ongoing.