Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).
Sponsor: European Foundation for Study of Chronic Liver Failure
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-07-01
Completion Date
2025-09
Last Updated
2025-03-19
Healthy Volunteers
No
Interventions
Human albumin
Human 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
Enoxaparin 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
SMT will be considered non-study medication and is not specified in the protocol.
Locations (9)
Hôpital Beaujon
Clichy, France
Universitätsklinikum Aachen AöR
Aachen, Germany
Universität Münster
Münster, Germany
IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"
Turin, Piedmont, Italy
Hospital Universitari Vall d'Hebron-VHIR
Barcelona, Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Clínic de Barcelona-FCRB
Barcelona, Spain
Royal Free Hospital
London, United Kingdom