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Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis
Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

NCT06855056

CompletedN/A

Sponsor: European Foundation for Study of Chronic Liver Failure

Conditions: Liver Cirrhosis, Decompensated Cirrhosis of Liver

Countries: France, Germany, Italy, Spain, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

1. Age between 18 and 80 years.
2. 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.
3. Recovery from AD and expected to be discharged within the next 48 hours.

Exclusion Criteria:

1. Admission for planned diagnostic or therapeutic procedures
2. Active malignancy (except for hepatocellular carcinoma within the Milan criteria or nonmelanocytic skin cancer)
3. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months.
4. HIV positive (except undergoing treatment and who do not exhibit clinical manifestations of AIDS).
5. Ongoing alcohol use disorder with an expected low adherence to prescriptions as judged by physician
6. Previous liver or other organ transplantation
7. Patients with TIPS or other surgical porto-caval shunts
8. Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate \<20 ml/min according to the MDRD equations
9. Chronic heart failure NYHA class III or IV
10. Pulmonary disease GOLD III or IV
11. Patients with a history of significant extrahepatic disease with life expectancy \<6 months
12. Severe psychiatric disorders
13. Pregnancy and breast-feeding
14. Expected low adherence to study protocol as judged by physician
15. Patients who cannot provide written informed consent or refuse to participate
Locations (9)
  • Clichy, France
  • Aachen, Germany
  • Münster, Germany
  • Bologna, Italia, Italy
  • Torino, Italy
  • Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • London, United Kingdom