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OpenTrials
Completed

NCT Number: NCT02041637

Unknown Cause of Acute Liver Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Villejuif, 94800, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: At 3 months

Secondary outcomes

  1. Liver transplantation rate

    Time frame: At 3 months

  2. Overall survival rate

    Time frame: At 3 months

  3. post-transplant mortality rate

    Time frame: At 3 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: HASIPRO

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jan 22, 2014
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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