Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorEuropean Foundation for Study of Chronic Liver Failure
About this trial
The study aims to test the effectiveness of new biomarkers (measurable molecules in our body) in predicting the health outcome of patients with liver cirrhosis discharged from the hospital after a serious complication of the disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years.
Patients with decompensated cirrhosis admitted to hospital due to AD according to the EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portal hypertensive- related gastrointestinal bleeding, bacterial infection, or any combination of these), including those who presented ACLF during hospitalization.
Recovery from AD and expected to be discharged within the next 48 hours.
Disqualifiers
Admission for planned diagnostic or therapeutic procedures
Active malignancy (except for hepatocellular carcinoma within the Milan criteria or nonmelanocytic skin cancer)
Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months.
HIV positive (except undergoing treatment and who do not exhibit clinical manifestations of AIDS).
Trial population
Patients eligible for this study will be patients with decompensated cirrhosis expected to be discharged from the hospital within 48 hours after an index admission for AD according to the EASL-CLIF criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
189 Participants
are grouped into 1 trial groupGroup A: Patients with Decompensated Liver Cirrhosis
Trial outcomes
Primary outcomes
1
To test the prognostic accuracy of novel biomarkers identified within the DECISION project.
The primary objective will be evaluated assessing the following end-point: ● Survival at 3 months
Time frame
Until September 30th 2025Secondary outcomes
1
To characterize the clinical and biological features at the time of discharge predicting the 6-month outcome and the different trajectories of patients surviving a hospitalization for AD complicated or not by ACLF.
Secondary objectives will be evaluated assessing the following end-points: * Survival at 6 months * Incidence of emergent re-admissions to hospital at 3 months due to liver related causes * Incidence of emergent re-admissions to hospital at 6 months due to liver related causes * Incidence of emergent re-admissions to hospital at 3 months due to non liver related causes * Incidence of emergent re-admissions to hospital at 6 months due to non liver related causes * Incidence of ACLF at 3 months * Incidence of ACLF at 6 months * Incidence of TIPS insertion at 3 months * Incidence of TIPS insertion at 6 months
Time frame
Until September 30th 2025Sponsors and contacts
Click on the lead sponsor to view all of their trials.
European Foundation for Study of Chronic Liver Failure
Lead sponsor
Universität Münster
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
Hospital Universitari Vall d'Hebron Research Institute
Collaborator
Hospital Clinic of Barcelona
Collaborator
Hospital Universitario Ramon y Cajal
Collaborator
Beaujon Hospital
Collaborator
University Hospital, Aachen
Collaborator
A.O.U. Città della Salute e della Scienza
Collaborator
Source ClinicalTrials.gov