Unknown Cause of Acute Liver Failure

Liver Failure Clinical Trial

— HASIPRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041637
• Other study ID #: AOM11030
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: May 2, 2017
• Start date: June 2013
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Failure
• Liver Failure, Acute
• Unknown Etiology

Locations

Country	Name	City	State
France	AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		At 3 months
Secondary	Liver transplantation rate		At 3 months
Secondary	Overall survival rate		At 3 months
Secondary	post-transplant mortality rate		At 3 months