A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).
NCT ID: NCT05895136
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2024-07-01
2025-09-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Cohort 1 will receive standard medical treatment plus a combinatorial therapy of enoxaparin and human Albumin.
Cohort 2 (control) will receive only standard medical treatment.
TREATMENT
NONE
Study Groups
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Enoxaparin plus human albumin
Cohort 1 will receive standard medical treatment plus a combinatorial therapy of enoxaparin and human Albumin.
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.
Standard medical treatment
Cohort 2 (control) will receive only standard medical treatment.
Standard medical treatment
SMT will be considered non-study medication and is not specified in the protocol.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. CLIF-C AD score ≥ 45 at admission or at any time during hospital stay.
4. Recovery from AD and expected to be discharged within the next 72 hours.
Exclusion Criteria
2. Admission for planned diagnostic or therapeutic procedures
3. Recent acute bleeding (unless the cause has been effectively treated and there is no evidence of ongoing bleeding for at least 5 days)
4. Chronic bleeding requiring periodic blood transfusions
5. Presence of an ongoing acute complication of the disease (i.e. hepatic encephalopathy \[grade III or IV\])
6. Conditions with a high risk of haemorrhage, including haemorrhagic diathesis not related to liver disease
7. Patients with INR \> 3.0
8. Severe thrombocytopenia (\<30x10 9 /L)
9. Ongoing chronic anticoagulation therapy or indication for starting anticoagulation due to hepatic and non-hepatic conditions
10. Ongoing anti-platelets therapy.
11. Active malignancy (except for hepatocellular carcinoma within the Milan criteria or non-melanocytic skin cancer)
12. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months
13. Ongoing alcohol use disorder with an expected low adherence to protocol as judged by physician
14. Previous liver transplantation
15. Patients with TIPS or other surgical porto-caval shunts
16. Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate \<30 ml/min according to the MDRD equations
17. Chronic heart failure NYHA class III or IV
18. Pulmonary disease GOLD III or IV
19. Patients with extrahepatic diseases with life expectancy \<6 months
20. Severe psychiatric disorders
21. Hypersensitivity to albumin preparations or to any of the excipients.
22. Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients
23. History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies
24. Pregnancy and breast-feeding
25. Expected low adherence to study protocol as judged by physician
26. Patients who can't provide written informed consent or refusal to participate
27. Participation in other concurrent clinical trials and within the prior 3 months from informed consent signature.
18 Years
80 Years
ALL
No
Sponsors
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Horizon 2020 - European Commission
OTHER
European Foundation for Study of Chronic Liver Failure
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Tony Bruns, PI
Role: primary
Jonel Trebicka, PI
Role: primary
Agustín Albillos, PI
Role: primary
Other Identifiers
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COMBAT
Identifier Type: -
Identifier Source: org_study_id
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