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
N/A
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
Researchers are evaluating a new combined therapy using human albumin and enoxaparin in patients with decompensated cirrhosis who are discharged from the hospital. The study aims to determine if this combined treatment is safe, tolerable, effective, and whether it costs more or less compared to standard medical treatment. This Phase 2 clinical trial will compare patients receiving the combinatorial therapy plus standard care to those receiving only standard care to see how they respond over time. Participants are randomly assigned to one of two groups: one group receives standard medical treatment along with the combined therapy of enoxaparin and human albumin, while the control group receives only standard medical treatment. The study involves treatment and follow-up over a period that includes monitoring at 30, 90, and 180 days after baseline to assess various health outcomes and complications. During the study, participants will attend visits where researchers will perform tests to track disease progression and response to treatment. Assessments include monitoring adverse events such as pulmonary edema, bleeding, and thrombocytopenia, as well as changes in liver and kidney function, hospital readmissions, survival rates, quality of life measures, and overall healthcare costs. Safety and tolerability are closely observed from baseline to day 90, with continued evaluation up to 180 days. Total study participation may last about six months from baseline.
CONDITIONS
Brief 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 according to EASL-CLIF criteria
- CLIF-C AD score of 45 or higher at admission or during hospital stay
- Recovery from acute decompensation and expected discharge within 72 hours
You will not qualify if you...
- Acute-on-chronic liver failure grade 3 or higher at admission or during hospitalization
- Admission for planned diagnostic or therapeutic procedures
- Recent acute bleeding without at least 5 days free of bleeding
- Chronic bleeding requiring blood transfusions
- Acute complications like hepatic encephalopathy grade III or IV
- Conditions with high bleeding risk unrelated to liver disease
- INR greater than 3.0
- Severe low platelet count (below 30x10^9/L)
- Ongoing anticoagulation or need to start anticoagulation
- Ongoing anti-platelet therapy
- Active cancer except certain liver or skin cancers
- Recent or planned antiviral treatment for hepatitis
- Ongoing alcohol use disorder with poor protocol adherence
- Previous liver transplant
- Presence of TIPS or other porto-caval shunts
- Severe chronic kidney failure (stage IV or V) or low GFR below 30 ml/min
- Severe chronic heart failure (NYHA class III or IV)
- Severe pulmonary disease (GOLD III or IV)
- Extrahepatic diseases with life expectancy under 6 months
- Severe psychiatric disorders
- Allergy to albumin or enoxaparin or related substances
- History of immune-mediated heparin-induced thrombocytopenia
- Pregnancy or breastfeeding
- Expected poor adherence to study protocol
- Inability or refusal to provide informed consent
- Participation in other clinical trials within 3 months prior
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days
Participants receive either a combinatorial therapy of enoxaparin and human albumin along with standard medical treatment or standard medical treatment alone to manage decompensated cirrhosis.
Regular visits during the treatment period as per protocol
Duration - Up to 180 days from baseline
Participants are monitored for safety, tolerability, clinical outcomes, and changes in organ function after treatment ends.
Visits at 90 and 180 days from baseline
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
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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