Unknown Cause of Acute Liver Failure

NCT ID: NCT02041637

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-01-31

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.

Conditions

Liver Failure; Unknown Etiology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Audrey COILLY, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Didier Samuel, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

Villejuif, , France

Countries

France

Other Identifiers

AOM11030

Identifier Type: -

Identifier Source: org_study_id