ALFSGA Multi-Center Trial to Study Acute Liver Failure in Adults
Data Collection
Collected from today forward - ProspectiveDigestive System Diseases+2
+ Liver Diseases
+ Liver Failure
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: January 1, 1998
Actual date on which the first participant was enrolled.Although ALF is truly an orphan disease affecting only about 2,000 persons per year, its severity, its frequency among young adults, and its high resource utilization justifies the attention paid to it. In addition, ALF has captured the interest and attention of researchers because of its unique pathogenesis and extreme severity, encouraging us to understand the processes underlying all forms of liver injury, by focusing on this most lethal manifestation. The etiologies associated with ALF have continued to change further over the years with an apparent decline in viral hepatitis, and a remarkable increase in acetaminophen toxicity to its current level of \~44-50% of cases. A further problem in studying ALF is that the number of cases of a specific etiology observed at any one institution are vanishingly small. The earliest goals of the ALF Study then were to more carefully define the etiologies of ALF on a national scale, and to finally allow in-depth study of specific ALF causes such as autoimmune ALF, viral hepatitis and Wilson disease (WD). A second group of patients worthy of study are those with acute liver injury.It would be of value to study patients destined to possibly have ALF earlier in their illness for several reasons: first, we might be able to better predict who will progress to full liver failure; second, the current definition requiring encephalopathy limits the number of patients available for study at any site; finally, therapeutic trials might have greater efficacy if begun at earlier disease stages. Patients who are enrolled are referred to ALFSG clinical sites by gastroenterologist/hepatologist and fellows. Detailed clinical data and bio-specimen (sera, urine, plasma, DNA and tissue if available) are collected. Subjects are followed long-term at 6 months and 12 months. Detailed clinical data and sera are collected.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3488 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
ALF Inclusion Criteria: * Written Informed consent from patient's next of kin * Altered mentation of any degree (encephalopathy) * Evidence of moderately severe coagulopathy (INR ≥ 1.5) * A presumed acute illness onset of less than 26 weeks * The NIH guidelines on the inclusion of women and minorities as subjects in clinical research will be observed ALF Exclusion Criteria: * Cirrhosis patients * Alcohol induced liver failure * Known pre-existing chronic liver disease ALI Inclusion Criteria: Acetaminophen (APAP) etiology: acute illness \< 2 wks * INR ≥ 2.0, ALT ≥ 10X ULN Non-acetaminophen etiology: acute illness \< 26 wks * INR≥ 2.0, ALT≥ 10X ULN, TBili ≥ 3 mg/dl ALI Exclusion Criteria: • Altered mentation of any degree (encephalopathy)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
University of Alabama at Birmingham
Birmingham, United StatesOpen University of Alabama at Birmingham in Google MapsUniversity of California, San Francisco
San Francisco, United StatesYale Medical School
New Haven, United StatesNorthwestern University Medical School
Chicago, United States