An European multinational study of a personalized approach of human albumin administration in patients with cirrhosis of the liver and complications

Ki vehet részt

• Decompensated liver cirrhosis defined as Child-Pugh score 7-12
• Clinical and/or ultrasound evidenced ascites
• Age above or equal to 18 years
• At least five days since resolution of a decompensation event or any condition requiring hospitalization

Ki nem vehet részt

• Current, planned or previous treatment with direct antiviral agents for HCV in the last six months
• Participation in another study within 3 months prior to screening
• Previous liver or other transplantation
• Patients who decline to participate, patients who cannot provide prior written informed consent due to other causes than hepatic encephalopathy or patients with hepatic encephalopathy who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker or sufficient ability to provide delayed informed consent
• Patients with acute or subacute liver failure without underlying cirrhosis
• Portal vein thrombosis without signs of cavernous transformation or recanalization
• Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score > 11)
• Evidence of current malignancy except for non-melanocytic skin cancer and hepatocellular carcinoma within BCLC-0 or BCLC-A
• Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (NYHA above grade II), severe chronic pulmonary disease (GOLD Score above or equal to grade C), severe neurological and psychiatric disorders, pulmonary arterial hypertension)
• HIV positive or other condition associated with and/or requiring immunosuppression
• Contraindications for human albumin infusion (pulmonary oedema, hypersensitivity etc.)
• Refractory ascites as defined by the International Ascites Club
• Existing TIPS inserted <6 months ago
• Hepatic encephalopathy grade III-IV
• Pregnancy
• Breastfeeding
• Physician’s denial (investigator considers that the patient will not adhere to the study protocol scheduled, e.g. in case of heavy drinking)
• Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy