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

Completed

• Conditions: Hepatic Encephalopathy; Acute Liver Failure

• Registration Number: NCT00986648
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (20)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Riley Children's Hospital; 🇺🇸 Indianapolis, Indiana, United States

Emory University, Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States

Harvard University, Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Columbia-Presbyterian; 🇺🇸 New York, New York, United States

St. Louis Children's Hospital; 🇺🇸 St. Louis, Missouri, United States

University of Cincinnati, Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

University of Washington; 🇺🇸 Seattle, Washington, United States

Birmingham Children's Hospital; 🇬🇧 Birmingham, United Kingdom

King's College Hospital (London, UK); 🇬🇧 London, United Kingdom

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States