The CirrhoCare trial is a multi-centre, open label randomised controlled trial in patients with decompensated cirrhosis. The trial aims to investigate the clinical and cost-effectiveness of CirrhoCare digital home monitoring and management with current standard of care in these patients.
Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included. However, participants with cirrhosis due to autoimmune hepatitis must be on a stable corticosteroid dose for ≥3-month period before study inclusion (to be recorded on concomitant log).
Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C AD score) ≥42 points but ≤65 points at the time of screening.
Hospitalisation for acute decompensation [determined as one or more of the following: increasing ascites, variceal haemorrhage, overt hepatic encephalopathy, spontaneous bacterial peritonitis (SBP) or hepatorenal syndrome - acute kidney injury (HRS-AKI)].
Participants with ACLF grade 2 and above according to the criteria published by Moreau
Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.
Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent.
Participants with active hepatocellular carcinoma (HCC) or history of HCC that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria.
University College, London
Lead sponsor
CyberLiver Ltd
Collaborator
London School of Hygiene and Tropical Medicine
Collaborator