Combining Albumin and Enoxaparin for Patients with Decompensated Cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and effectiveness of a novel combinatorial therapy using human albumin and enoxaparin in patients with decompensated cirrhosis who are at high risk of poor outcomes. Participants will be divided into two groups: one receiving the combinatorial therapy alongside standard treatment, and the other receiving only standard treatment. The study aims to assess the tolerability of the therapy, its effectiveness in improving patient outcomes, and its cost compared to standard medical therapy. Regular study visits will be conducted to monitor disease progression and response to treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola
  Bologna, Emilia-Romagna, Italy Recruiting
• Hôpital Beaujon
  Clichy, France Completed
• Universitätsklinikum Aachen AöR
  Aachen, Germany Completed
• Universität Münster
  Münster, Germany Completed
• Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"
  Turin, Piedmont, Italy Completed
• Hospital Universitari Vall d'Hebron-VHIR
  Barcelona, Spain Completed

Study contacts

• Study coordinator: Anna Bosch
• Email: anna.bosch@efclif.com
• Phone: +34 93 227 14 03

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.