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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00986648
First received: September 29, 2009
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition
Acute Liver Failure
Hepatic Encephalopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center Group to Study Acute Liver Failure in Children

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA

whole blood, serum, tissue


Estimated Enrollment: 300
Study Start Date: January 2000
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children between birth and age 18 years who present with acute liver failure.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986648

Contacts
Contact: Robert H Squires, MD 412-692-8181 robert.squires@chp.edu

  Show 20 Study Locations
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Robert H Squires, MD Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh
  More Information

Publications:

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00986648     History of Changes
Other Study ID Numbers: 1 UO1 DK072146-01, U01DK072146, 2U01DK072146-06
Study First Received: September 29, 2009
Last Updated: June 6, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
acute liver failure
hepatic encephalopathy
acetaminophen toxicity

Additional relevant MeSH terms:
Liver Failure
Liver Failure, Acute
Liver Diseases
Hepatic Encephalopathy
Brain Diseases
Brain Diseases, Metabolic
Central Nervous System Diseases
Digestive System Diseases
Hepatic Insufficiency
Metabolic Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014