A Multi-Center Group to Study Acute Liver Failure in Children
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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:
- 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
Contacts and Locations| Contact: Robert H Squires, MD | 412-692-8181 | robert.squires@chp.edu |
Show 20 Study Locations| 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: | November 12, 2012 |
| 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 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 |
ClinicalTrials.gov processed this record on June 17, 2013