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

Fulminating Hepatic Failure Clinical Trial

— DEVINHEF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04658407
• Other study ID #: AP-HP200240
• Status: Not yet recruiting
• Start date: April 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Philippe ICHAI
• Phone: 01 45 59 64 35
• Email: philippe.ichai[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18000
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fulminating Hepatic Failure
• Hepatic Insufficiency
• Liver Failure
• Liver Failure, Acute

Locations

Country	Name	City	State
France	Paul Brousse Hospital	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Epidemiology of Severe and fulminating acute hepatic failure	Sex Ratio M / F and cause of liver failure	Baseline
Secondary	Cause of death	Cause of death	From date of inclusion until the date of death from any cause, assessed up to 9 years
Secondary	Analysis of Clinical Pathway	Identification of the different services visited	up to 1month after the diagnosis of this episode
Secondary	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