A Multi-Center Group to Study Acute Liver Failure in Children - NCT00986648-10029 (Clinical Trial 353154)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy353154.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10029 |
| Conditions: |
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Acute Liver Failure - Hepatic Encephalopathy |
| Purpose: |
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The PALF study group includes 20 sites (17 in the United States, 2 in the United Kingdom,
and 1 in Canada). 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.
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| Study summary: |
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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 plasma 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 including the role of
fatty acid oxidation defects, the prevalence of NK cell and other immune cell dysfunction in
children with ALF and examine the impact of unsuspected acetaminophen (APAP) toxicity in the
pathogenesis of ALF. |
| Criteria: |
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Inclusion Criteria:
- Evidence of acute liver injury: defined as severe liver dysfunction occurring within
8 weeks of onset of illness, with no known underlying chronic liver disease
- INR ≥ 1.5 or protime ≥ 15 seconds with encephalopathy OR INR ≥ 2.0 or protime ≥ 20
seconds with or without encephalopathy
- The patient is under 18 years of age at the time of enrollment
- Informed consent is obtained from the parent, or guardian, and patient assent is
obtained when applicable
Exclusion Criteria:
- Known chronic underlying liver disease
- Coagulopathy corrected with Vitamin K |
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| Study is available at: |
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Mount Sinai Hospital
New York, NY 10029
United States
Primary Contact:
Nanda Kerkar, M.D.
Email: nanda.kerkar@mountsinai.org
Phone: 212-241-8063
Secondary Contact:
Robert H Squires, MD
Email: robert.squires@chp.edu
Phone: 412-692-8181 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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