Actively Recruiting
A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).
Led by European Foundation for Study of Chronic Liver Failure · Updated on 2025-03-19
90
Participants Needed
9
Research Sites
61 weeks
Total Duration
On this page
Sponsors
E
European Foundation for Study of Chronic Liver Failure
Lead Sponsor
H
Horizon 2020 - European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Patients with decompensated cirrhosis admitted to hospital due to acute decompensation (rapid onset of ascites, hepatic encephalopathy, portal hypertensive-related gastrointestinal bleeding, bacterial infection, or combination)
- CLIF-C AD score of 45 or higher at admission or during hospital stay
- Recovery from acute decompensation and expected hospital discharge within 72 hours
You will not qualify if you...
- Acute-on-chronic liver failure grade 3 or higher at admission or during hospital stay
- Admission for planned diagnostic or therapeutic procedures
- Recent acute bleeding unless effectively treated and no ongoing bleeding for at least 5 days
- Chronic bleeding requiring periodic blood transfusions
- Ongoing acute complications like hepatic encephalopathy grade III or IV
- High risk of hemorrhage including hemorrhagic diathesis unrelated to liver disease
- INR greater than 3.0
- Severe thrombocytopenia (platelets less than 30x10^9/L)
- Ongoing chronic anticoagulation therapy or indication to start it
- Ongoing antiplatelet therapy
- Active malignancy except hepatocellular carcinoma within Milan criteria or non-melanocytic skin cancer
- Antiviral treatment for hepatitis C, B, or delta started within last 6 months or planned within next 6 months
- Ongoing alcohol use disorder with expected low protocol adherence
- Previous liver transplantation
- Patients with TIPS or other surgical porto-caval shunts
- Chronic organic renal failure stage IV or V or estimated GFR less than 30 ml/min
- Chronic heart failure NYHA class III or IV
- Pulmonary disease GOLD III or IV
- Extrahepatic diseases with life expectancy less than 6 months
- Severe psychiatric disorders
- Hypersensitivity to albumin or enoxaparin or related compounds
- History of immune-mediated heparin-induced thrombocytopenia within past 100 days or with circulating antibodies
- Pregnancy and breastfeeding
- Expected low adherence to protocol
- Unable or unwilling to provide written informed consent
- Participation in other clinical trials within 3 months prior to consent
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Hôpital Beaujon
Clichy, France, 92110
Actively Recruiting
2
Universitätsklinikum Aachen AöR
Aachen, Germany, 52074
Actively Recruiting
3
Universität Münster
Münster, Germany, 48149
Actively Recruiting
4
IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
5
Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"
Turin, Piedmont, Italy, 10126
Actively Recruiting
6
Hospital Universitari Vall d'Hebron-VHIR
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
7
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
8
Hospital Clínic de Barcelona-FCRB
Barcelona, Spain, 08036
Actively Recruiting
9
Royal Free Hospital
London, United Kingdom, NW3 2QG
Not Yet Recruiting
Research Team
A
Anna Bosch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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