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

• Conditions: Fulminating Hepatic Failure

• Registration Number: NCT04658407
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-08
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-01
• Study Start: 2021-04-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	1 month from the diagnosis of this episode	Patient status 1 month after diagnosis of this episode (alive or dead with or without transplantation)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Paul Brousse Hospital; 🇫🇷 Villejuif, France