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

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00986648

Collaborator

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

158

Enrollment

Locations

191

Duration (Months)

7.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Liver Failure Hepatic Encephalopathy

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 Design

Study Type:

Observational

Actual Enrollment :

158 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143
2	Children's Hospital Colorado	Aurora	Colorado	United States	80045
3	Emory University, Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30322
4	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
5	Riley Children's Hospital	Indianapolis	Indiana	United States	46202
6	Johns Hopkins University	Baltimore	Maryland	United States	21287
7	Harvard University, Boston Children's Hospital	Boston	Massachusetts	United States	02115
8	University of Michigan	Ann Arbor	Michigan	United States	48109
9	St. Louis Children's Hospital	St. Louis	Missouri	United States	63110
10	Mount Sinai Hospital	New York	New York	United States	10029
11	Columbia-Presbyterian	New York	New York	United States	10032
12	University of Cincinnati, Cincinnati Children's Hospital	Cincinnati	Ohio	United States	45229
13	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
14	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15224
15	Children's Medical Center of Dallas	Dallas	Texas	United States	75235
16	Baylor College of Medicine	Houston	Texas	United States	77030
17	University of Washington	Seattle	Washington	United States	98105
18	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8
19	Birmingham Children's Hospital	Birmingham		United Kingdom	B4 6NH
20	King's College Hospital (London, UK)	London		United Kingdom	SE59RS