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

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Foundation for Study of Chronic Liver Failure
• Treatments: Enoxaparin

Criteria

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 48-72 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

• Admission for planned diagnostic or therapeutic procedures

• Recent acute bleeding (unless the cause has been effectively treated and evidence of ongoing bleeding has not been identified for at least 5 days)

• Chronic bleeding requiring periodic blood transfusions

• Severe thrombocytopenia (≤20x109/L)

• Ongoing chronic anticoagulation therapy or indication for starting anticoagulation due to hepatic and non-hepatic conditions

• 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 <20 ml/min according to the MDRD equations

• Chronic heart failure NYHA class III or IV

• Pulmonary disease GOLD III or IV

• Patients with a history of significant extrahepatic disease with life expectancy <6 months

• Severe psychiatric disorders

• Known allergy or intolerance to human albumin or enoxaparin

• Pregnancy and breast-feeding

• Expected low adherence to study protocol as judged by physician

• Refusal to participate (no signed informed consent)

• Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision-maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.