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

Completed

Conditions studied: Acute Liver Failure, Hepatic Encephalopathy

In brief

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.

Key facts

Study ID

NCT00986648

Run by

University of Pittsburgh

People needed

158

Starts

2000-01-01

Expected to finish

2015-12-01

Last updated by the study team

2016-01-12

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Emory University, Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Riley Children's Hospital — Indianapolis, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Harvard University, Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Mount Sinai Hospital — New York, New York, United States
• Columbia-Presbyterian — New York, New York, United States
• University of Cincinnati, Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States
• Hospital for Sick Children — Toronto, Ontario, Canada
• Birmingham Children's Hospital — Birmingham, United Kingdom
• King's College Hospital (London, UK) — London, United Kingdom

Full record on ClinicalTrials.gov

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