Unknown Cause of Acute Liver Failure

Completed

• Conditions: Unknown Etiology; Liver Failure

• Registration Number: NCT02041637
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The purpose of the study is to evaluate the outcome and to determine predictive factors of patients admitted in a context of acute liver failure without identified cause.

Detailed Description

Methodology: Multicentric French national cohort with prospective collection of data and constitution of biobank, in patients hospitalized in a context of acute liver failure without known cause at admission. Follow-up during 3 months for each patients. The primary objective is to determine predictive factors of early mortality. This study is an observational cohort and patients will received standard care during the follow-up.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-22
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Acute liver failure defined by a PT<50% or INR>1.5;
• with or without hepatic encephalopathy;
• without cause identified at admission, and non A non B hepatitis;
• age>18 year old;
• signed an informed consent.

Exclusion Criteria

• chronic liver disease;
• Patient under guardianship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality	At 3 months

Secondary Outcome Measures

Name	Time	Method
Overall survival rate	At 3 months
post-transplant mortality rate	At 3 months
Liver transplantation rate	At 3 months

Trial Locations

Locations (1)

AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire; 🇫🇷 Villejuif, France