A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).

Ki vehet részt

• 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)
• CLIF-C AD score ≥ 45 at admission or at any time during hospital stay
• Recovery from AD and expected to be discharged within the next 72 hours

Ki nem vehet részt

• Previous liver transplantation
• Patients with TIPS or other surgical porto-caval shunts
• Participation in other concurrent clinical trials and within the prior 3 months from informed consent signature
• Diagnosis of acute-on-chronic liver failure (ACLF) grade 3 or higher according to the EASL-CLIF criteria at admission or at any time during the index hospitalization
• Recent acute bleeding (unless the cause has been effectively treated and there is no evidence of ongoing bleeding for at least 5 days)
• Chronic bleeding requiring periodic blood transfusions
• Presence of an ongoing acute complication of the disease (i.e. hepatic encephalopathy [grade III or IV])
• Conditions with a high risk of haemorrhage, including haemorrhagic diathesis not related to liver disease
• Ongoing chronic anticoagulation therapy or indication for starting anticoagulation due to hepatic and non-hepatic conditions
• Active malignancy (except for hepatocellular carcinoma within the Milan criteria or non-melanocytic 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
• Ongoing alcohol use disorder with an expected low adherence to protocol as judged by physician
• Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate <30 ml/min according to the MDRD equations
• Chronic heart failure NYHA class III or IV
• Pulmonary disease GOLD III or IV
• Patients with extrahepatic diseases with life expectancy <6 months
• Severe psychiatric disorders
• History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies
• Patients with INR > 3.0
• Severe thrombocytopenia (<30x10 9 /L)
• Ongoing anti-platelets therapy
• Hypersensitivity to albumin preparations or to any of the excipients
• Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients
• Admission for planned diagnostic or therapeutic procedures
• Pregnancy and breast-feeding
• Expected low adherence to study protocol as judged by physician
• Patients who can't provide written informed consent or refusal to participate