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

Launched by EUROPEAN FOUNDATION FOR STUDY OF CHRONIC LIVER FAILURE · Jun 6, 2023

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ClinConnect Summary

**Summary of the COMBAT Trial**

The COMBAT Trial is a clinical study aimed at discovering whether a combination therapy using human albumin and enoxaparin is safe and effective for patients with liver cirrhosis who are at high risk for serious health issues. The main focus of this trial is to find out if this new treatment helps patients recover better after being discharged from the hospital compared to standard care. The study will also look into whether this therapy costs more or less than the usual treatments.

To be eligible for this trial, participants should be between 18 and 80 years old and have been hospitalized for complications related to liver cirrhosis. They must show signs of recovery and be expected to leave the hospital soon. Those who join the study will have regular visits where doctors will check their health and monitor how well the treatment is working. It’s important to note that certain health conditions or treatments may exclude individuals from participating. Overall, this trial could provide valuable insights into improving care for patients with liver cirrhosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 80 years.
• • 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:
• • 1. 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
• • 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.