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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by (Responsible Party): | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00986648 |
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 |
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) |
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 |
Children between birth and age 18 years who present with acute liver failure.
Inclusion Criteria:
Coagulopathy not corrected by vitamin K
Exclusion Criteria:
Contacts and Locations
Show 20 Study Locations| Principal Investigator: | Robert H Squires, MD | Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh |
More Information
| 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: | January 24, 2012 |
| Health Authority: | United States: Federal Government |
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acute liver failure hepatic encephalopathy acetaminophen toxicity |
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Hepatic Encephalopathy Brain Damage, Chronic Delirium Encephalitis Neurotoxicity Syndromes Liver Failure Liver Failure, Acute Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Metabolic Diseases Confusion Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Poisoning Substance-Related Disorders |