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

September 29, 2009
June 6, 2014
January 2000
August 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00986648 on ClinicalTrials.gov Archive Site
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A Multi-Center Group to Study Acute Liver Failure in Children
A Multi-Center Group to Study Acute Liver Failure in Children

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

whole blood, serum, tissue

Probability Sample

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

  • Acute Liver Failure
  • Hepatic Encephalopathy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
August 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact: Robert H Squires, MD 412-692-8181 robert.squires@chp.edu
United States,   Canada,   United Kingdom
 
NCT00986648
1 UO1 DK072146-01, U01DK072146, 2U01DK072146-06
Yes
University of Pittsburgh
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Robert H Squires, MD Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh
University of Pittsburgh
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP