A novel COMBinATorial therapy with albumin and enoxaparin in patients with decompensated cirrhosis at high-risk of poor outcome (COMBAT trial).

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

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 >= 50 at admission or at any time during hospital stay., Recovery from AD and expected to be discharged within the next 72 hours.

Exclusion Criteria

Diagnosis of acute-on-chronic liver failure (ACLF) grade 2 or higher according to the EASL-CLIF criteria at admission or at any time during the index hospitalization, Ongoing anti-platelets therapy., 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, Previous liver transplantation, Patients with TIPS or other surgical porto-caval shunts, 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, Admission for planned diagnostic or therapeutic procedures, Severe psychiatric disorders, 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, History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies, 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, Participation in other concurrent clinical trials and within the prior 3 months from informed consent signature., 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, Patients with INR > 3.0, Severe thrombocytopenia (<30x109/L), Ongoing chronic anticoagulation therapy or indication for starting anticoagulation due to hepatic and non-hepatic conditions

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability of the combinatorial therapy (human albumin and enoxaparin) in terms of TEAE (pulmonary edema, major bleeding and/or thrombocytopenia).;Secondary Objective: To evaluate signals of efficacy of the combinatorial therapy., To explore the impact of the combinatorial therapy on pathophysiological mechanisms of cirrhosis in blood samples extracted at several time points., To explore the role of selected biomarkers in predicting the response to the combinatorial therapy in blood samples extracted at several time points., To estimate the healthcare costs associated with the combinatorial therapy;Primary end point(s): The percentage of subjects who experience at least 1 treatment-emergent adverse events (TEAE) or serious adverse events (SAE), The percentage of subjects who discontinue the study drug due to pulmonary edema, severe thrombocytopenia and/or major bleeding according to the definition by Shulman et al (56)

Secondary Outcome Measures

Name	Time	Method

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