The goal of this clinical trial is to determine primarily whether a combinatorial therapy based on the administration of human albumin and enoxaparin is safe and effective in patients with decompensated cirrhosis discharged from the hospital. The main questions it aims to answer are:
* Is this combinatorial therapy safe and tolerable? * Is this combinatorial therapy effective? * does this combinatorial therapy cost more or less than standard medical therapy? Participants will attend to study visits in which several test will be performed to asses disease evolution while they are taking study medication.
Researchers will compare experimental group treated with combinatorial therapy plus standard treatment with control group treated with standard treatment to see if there are differences in the responses to the questions raised above.
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.
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
Admission for planned diagnostic or therapeutic procedures
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
Parallel
Human albumin
DrugHuman albumin solution is made from pooled human plasma. It is widely used as a plasma-expander in several disease conditions, such as liver cirrhosis and critically ill patients. ATC-Code: B05AA01
Enoxaparin
DrugEnoxaparin is a drug that belongs to the group of anticoagulants. It exerts its antithrombotic activity by binding to antithrombin III (AT III). ATC-Code: B01AB05
Standard medical treatment
DrugSMT will be considered non-study medication and is not specified in the protocol.
To assess the safety and tolerability of the combinatorial therapy in terms of TEAE (pulmonary edema, major bleeding and/or thrombocytopenia
The safety and tolerability of the combinatorial therapy of human albumin and enoxaparin on top of SMT compared to SMT alone, from baseline to Day 90, will be evaluated as the percentage of subjects who discontinued the study drug due to at least 1 of the following treatment-emergent adverse events (TEAE): pulmonary edema, severe thrombocytopenia and/or major bleeding. These variables will be described (counts and percentage).
90 and 180-days changes in prognostic scores of CLIF-Consortium Acute Decompensation score (CLIF-C AD) from baseline.
Lower scores of CLIF-C AD (\<45) indicate a better prognostic than greater values (\>50). In the statistical analysis Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
90 and 180-days changes in prognostic scores of Mayo End stage Liver Disease (MELD) from baseline.
The MELD score ranges from six to 40 and is based on results from several lab tests. The higher the number, the more likely you are to receive a liver from a deceased donor when an organ becomes available. Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
90 and 180-days changes in prognostic scores of Mayo End stage Liver Disease - sodio (MELDNa) from baseline
The MELDNa score ranges from six to 40 and is based on results from several lab tests. The higher the number, the more likely you are to receive a liver from a deceased donor when an organ becomes available. Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
30 days, 90 and 180-days incidence of hospital readmission and ICU admission (causes and length of stay)
Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
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European Foundation for Study of Chronic Liver Failure
Lead sponsor
Horizon 2020 - European Commission
Collaborator
