Phase
Condition
Liver Failure
Liver Disease
Scar Tissue
Treatment
Human albumin
Standard medical treatment
Enoxaparin
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age between 18 and 80 years.
Patients with decompensated cirrhosis admitted to hospital due to AD according tothe EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portalhypertensive-related gastrointestinal bleeding, bacterial infection, or anycombination of these).
CLIF-C AD score ≥ 45 at admission or at any time during hospital stay.
Recovery from AD and expected to be discharged within the next 72 hours.
Exclusion
Exclusion Criteria:
Diagnosis of acute-on-chronic liver failure (ACLF) grade 3 or higher according tothe EASL-CLIF criteria at admission or at any time during the index hospitalization
Admission for planned diagnostic or therapeutic procedures
Recent acute bleeding (unless the cause has been effectively treated and there is noevidence of ongoing bleeding for at least 5 days)
Chronic bleeding requiring periodic blood transfusions
Presence of an ongoing acute complication of the disease (i.e. hepaticencephalopathy [grade III or IV])
Conditions with a high risk of haemorrhage, including haemorrhagic diathesis notrelated to liver disease
Patients with INR > 3.0
Severe thrombocytopenia (<30x10 9 /L)
Ongoing chronic anticoagulation therapy or indication for starting anticoagulationdue to hepatic and non-hepatic conditions
Ongoing anti-platelets therapy.
Active malignancy (except for hepatocellular carcinoma within the Milan criteria ornon-melanocytic skin cancer)
Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months orplanned to be initiated in the following 6 months
Ongoing alcohol use disorder with an expected low adherence to protocol as judged byphysician
Previous liver transplantation
Patients with TIPS or other surgical porto-caval shunts
Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate <30 ml/min according to the MDRD equations
Chronic heart failure NYHA class III or IV
Pulmonary disease GOLD III or IV
Patients with extrahepatic diseases with life expectancy <6 months
Severe psychiatric disorders
Hypersensitivity to albumin preparations or to any of the excipients.
Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including otherlow molecular weight heparins (LMWH) or to any of the excipients
History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies
Pregnancy and breast-feeding
Expected low adherence to study protocol as judged by physician
Patients who can't provide written informed consent or refusal to participate
Participation in other concurrent clinical trials and within the prior 3 months frominformed consent signature.
Study Design
Connect with a study center
Hôpital Beaujon
Clichy, 92110
FranceActive - Recruiting
Universitätsklinikum Aachen AöR
Aachen, 52074
GermanyActive - Recruiting
Universität Münster
Münster, 48149
GermanyActive - Recruiting
IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola
Bologna, Emilia Romagna 40138
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"
Torino, Piemonte 10126
ItalyActive - Recruiting
Hospital Clínic de Barcelona-FCRB
Barcelona, 08036
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron-VHIR
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
SpainActive - Recruiting
Royal Free Hospital
London, NW3 2QG
United KingdomSite Not Available
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