A Multi-Center Group to Study Acute Liver Failure in Children
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| ClinicalTrials.gov Identifier: NCT00986648 |
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Recruitment Status :
Completed
First Posted : September 30, 2009
Last Update Posted : January 12, 2016
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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
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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 |
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| Acute Liver Failure Hepatic Encephalopathy |
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 : | 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 : | January 2000 |
| Actual Primary Completion Date : | December 2015 |
| Actual Study Completion Date : | December 2015 |
Resource links provided by the National Library of Medicine
Biospecimen Retention: Samples With DNA
whole blood, serum, tissue
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986648
Locations
Show 20 study locations
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
| Principal Investigator: | Robert H Squires, MD | Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00986648 |
| Other Study ID Numbers: |
1U01DK072146-01 ( U.S. NIH Grant/Contract ) U01DK072146 ( U.S. NIH Grant/Contract ) 2U01DK072146-06 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 30, 2009 Key Record Dates |
| Last Update Posted: | January 12, 2016 |
| Last Verified: | January 2016 |
Keywords provided by University of Pittsburgh:
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acute liver failure hepatic encephalopathy acetaminophen toxicity |
Additional relevant MeSH terms:
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Liver Failure Hepatic Insufficiency Hepatic Encephalopathy Liver Failure, Acute Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Metabolic Diseases |