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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEuropean Foundation for Study of Chronic Liver Failure

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Human albumin
  • Enoxaparin
  • Standard medical treatment

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

European Foundation for Study of Chronic Liver Failure

Lead sponsor

Horizon 2020 - European Commission

Collaborator