ALFSGA Multi-Center Trial to Study Acute Liver Failure in Adults
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveMaladies du système digestif+2
+ Maladies du foie
+ Insuffisance hépatique aiguë
Autre
Méthodes concernant des questions de recherche très spécifiques.Résumé
Date de début de l'étude : 1 janvier 1998
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.3488 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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)
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 12 sites
University of Alabama at Birmingham
Birmingham, United StatesOuvrir University of Alabama at Birmingham dans Google MapsUniversity of California, San Francisco
San Francisco, United StatesYale Medical School
New Haven, United StatesNorthwestern University Medical School
Chicago, United States