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Unknown Cause of Acute Liver Failure (HASIPRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02041637
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unknown Cause of Acute Liver Failure: Determination of Early Mortality Predictive Factors
Study Start Date : June 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017



Primary Outcome Measures :
  1. mortality [ Time Frame: At 3 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute liver failure without cause identified at admission
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041637


Locations
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France
AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire
Villejuif, France, 94800
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Audrey COILLY, MD Assistance Publique - Hôpitaux de Paris
Study Director: Didier Samuel, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02041637    
Other Study ID Numbers: AOM11030
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: April 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
liver failure
etiology
liver transplantation
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Liver Diseases
Digestive System Diseases