The goal of this clinical biomarker validation trial is to test the effect of a predictive biomarker panel to human albumin infusions in patients with liver cirrhosis and ascites. The main questions it aims to answer are:
* If the predictive biomarker panel can identify patients who are likely to benefit from regular human albumin infusions * If the predictive biomarker panel can lower the number-needed-to-treat of regular human albumin infusions in patients with liver cirrhosis and ascites
The predictive biomarker panel will stratify patients into either a high- or low-expected effect of human albumin infusions. Hereafter are participants randomized into treatment arms.
Participants in the active treatment arm will receive regular human albumin infusions during a course of 6 months. Infusions will occur every 10th day for the duration of the study.
Researchers will compare 20% human albumin infusions with regular 0.9% sodium chloride to identify the effects on the number of liver-related events.
Decompensated liver cirrhosis defined as Child-Pugh score 7-12
Clinical and/or ultrasound evidenced ascites
Age ≥ 18 years
At least five days since resolution of a decompensation event or any condition requiring hospitalisation
Patients with acute or subacute liver failure without underlying cirrhosis
Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy
Refractory ascites as defined by the International Ascites Club
Existing TIPS inserted <6 months ago
Aleksander Krag
Lead sponsor
Odense University Hospital
Sponsor institution
EASL - CLIF Consortium
Collaborator