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

This study is currently recruiting participants.

Verified November 2012 by University of Pittsburgh

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00986648

First received: September 29, 2009

Last updated: November 12, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 29, 2009

Last Updated Date

November 12, 2012

Start Date ^ICMJE

January 2000

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00986648 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

whole blood, serum, tissue

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Acute Liver Failure
Hepatic Encephalopathy

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

August 2015

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Written informed consent/assent
Birth through 17 years of age
Biochemical evidence of acute liver injury
Coagulopathy not corrected by vitamin K
- 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

Gender

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Robert H Squires, MD

412-692-8181

robert.squires@chp.edu

Location Countries ^ICMJE

United States, Canada, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00986648

Other Study ID Numbers ^ICMJE

1 UO1 DK072146-01, U01DK072146, 2U01DK072146-06

Has Data Monitoring Committee

Yes

Responsible Party

University of Pittsburgh

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators ^ICMJE

Principal Investigator:

Robert H Squires, MD

Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

November 2012

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

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