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

  Hide Study Locations
Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Philip Rosenthal, M.D.    415-476-5892    prosenth@peds.ucsf.edu   
Principal Investigator: Philip Rosenthal, M.D.         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Michael Narkewicz, M.D.    720-777-6669    Michael.Narkewicz@childrenscolorado.org   
Principal Investigator: Michael Narkewicz, M.D.         
United States, Georgia
Emory University, Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Rene Romero, M.D.    404-785-1832    rene.romero@choa.org   
Principal Investigator: Rene Romero, M.D.         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Estella Alonzo, M.D.    773-975-8837    EAlonso@luriechildrens.org   
Principal Investigator: Estella Alonzo, M.D.         
United States, Indiana
Riley Children's Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Girish Subbarao, MD    317-278-5804    gsrao@iupui.edu   
Principal Investigator: Girish Subbarao, MD         
United States, Maryland
Johns Hopkins University Completed
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Harvard University, Boston Children's Hospital Completed
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Completed
Ann Arbor, Michigan, United States, 48109
United States, Missouri
St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: David Rudnick, M.D.    314-286-2832    Rudnick_D@kids.wustl.edu   
Principal Investigator: David Rudnick, M.D.         
United States, New York
Columbia-Presbyterian Completed
New York, New York, United States, 10032
Mount Sinai Hospital Completed
New York, New York, United States, 10029
United States, Ohio
University of Cincinnati, Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Mike Leonis, M.D.    513-636-1923    mike.leonis@cchmc.org   
Principal Investigator: Mike Leonis, M.D.         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kathy Loomes, M.D.    267-426-7223    loomes@email.chop.edu   
Principal Investigator: Kathy Loomes, M.D.         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Robert H Squires, MD    412-692-8181    Robert.Squires@chp.edu   
Principal Investigator: Robert H. Squires, M.D.         
United States, Texas
Children's Medical Center of Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Norberto Rodriguez-Baez, M.D.    214-456-8037    norberto.rodriguez-baez@childrens.com   
Principal Investigator: Norberto Rodriguez-Baez, M.D.         
Baylor College of Medicine Completed
Houston, Texas, United States, 77030
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Simon Horslen, M.D.    206-987-2521    simon.horslen@seattlechildrens.org   
Principal Investigator: Simon Horslen, M.D.         
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Vicky Ng, M.D.    416-813-7733    vicky.ng@sickkids.ca   
Principal Investigator: Vicky Ng, M.D.         
United Kingdom
Birmingham Children's Hospital Completed
Birmingham, United Kingdom, B4 6NH
King's College Hospital (London, UK) Completed
London, United Kingdom, SE59RS
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:
Hepatic Encephalopathy
Brain Diseases
Liver Failure
Liver Failure, Acute
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on July 31, 2014