Patients' Outcome With Severe or Fulminant Hepatic Insufficiency, Hospitalized in the Public Hospitals of Paris (DEVINHEF)

Patients' Outcome With Severe or Fulminant Hepatic Insufficiency, Hospitalized in the Hospitals of the Assistance Publique - Hôpitaux de Paris (APHP)

The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris.

Study Overview

• Status: Unknown
• Conditions: Fulminating Hepatic Failure

Detailed Description

Severe, fulminating acute liver failure is a rare but serious disease. The overall prognosis has improved in recent years thanks to advances in medical management and liver transplantation.

However, the epidemiology of this disease in France, the survival with or without liver transplantation of these patients and the factors that can influence this survival are not well known.

The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris (APHP).

The data will come from the APHP Health Data Warehouse

• Study Type: Observational
• Enrollment (Anticipated): 18000

Contacts and Locations

• Study Contact: Name: Philippe ICHAI; Phone Number: 01 45 59 64 35; Email: philippe.ichai@aphp.fr

Study Locations

• France
  • Villejuif, France, 94804
    • Paul Brousse Hospital
    • Contact: Philippe ICHAI, MD, PhD; Phone Number: +33 (1) 45 59 64 35; Email: philippe.ichai@aphp.fr
    • Principal Investigator: Philippe ICAHI, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with Severe liver failure or toxicants that may cause a liver failure

Description

Inclusion Criteria:

• Age > 15
• Severe liver failure or toxicants that may cause a liver failure Or
• (PR<50% or INR >1.5) And ALT >250

Exclusion Criteria:

• Patients with underlying chronic liver disease
• Patients with the conditions given by this following ICD (International Classification of Diseases) : B18 - E831 - K70 - K715 - K717 - K730- K731 - K732 - 738 - K74 - K753 - K758 - K760 - K761

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
all patients diagnosed with a severe hepatic failure; Retrospective cohort using only data already entered in the Health data warehouse of the APHP (Public Paris Hospital)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe and fulminating acute hepatic failure within AP-HP hospitals	Patient status 1 month after diagnosis of this episode (alive or dead with or without transplantation)	1 month from the diagnosis of this episode

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidemiology of Severe and fulminating acute hepatic failure	Sex Ratio M / F and cause of liver failure	Baseline
Cause of death	Cause of death	From date of inclusion until the date of death from any cause, assessed up to 9 years
Analysis of Clinical Pathway	Identification of the different services visited	up to 1month after the diagnosis of this episode
Reasons for new hospitalizations with an admission date within 6 months after the diagnosis this episode	Identification by the usual code of the new hospitalization, consecutive to the episode	within 6 months after the diagnosis this episode

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
• Other Study ID Numbers: AP-HP200240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No