Unknown Cause of Acute Liver Failure (HASIPRO)

Unknown Cause of Acute Liver Failure: Determination of Early Mortality Predictive Factors

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.

Study Overview

• Status: Completed
• Conditions: Liver Failure; Unknown Etiology

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 Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• France
  • Villejuif, France, 94800
    • AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute liver failure without cause identified at admission

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mortality	At 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Liver transplantation rate	At 3 months
Overall survival rate	At 3 months
post-transplant mortality rate	At 3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Audrey COILLY, MD, Assistance Publique - Hôpitaux de Paris; Study Director: Didier Samuel, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: January 20, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: liver transplantation; liver failure; etiology
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
• Other Study ID Numbers: AOM11030