Status:
COMPLETED
A Multi-Center Group to Study Acute Liver Failure in Children
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Acute Liver Failure
Hepatic Encephalopathy
Eligibility:
All Genders
Up to 18 years
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...
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 ill...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00986648
Start Date
January 1 2000
End Date
December 1 2015
Last Update
January 12 2016
Active Locations (20)
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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