Phase
Condition
Scar Tissue
Hepatic Fibrosis
Hyponatremia
Treatment
CirrhoCare management system
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/orhistology. Cirrhosis of any aetiology may be included. However, participants withcirrhosis 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 timeof screening.
Hospitalisation for acute decompensation [determined as one or more of thefollowing: increasing ascites, variceal haemorrhage, overt hepatic encephalopathy,spontaneous bacterial peritonitis (SBP) or hepatorenal syndrome - acute kidneyinjury (HRS-AKI)].
Participants able to give informed consent.
Exclusion
Exclusion criteria:
Participants with ACLF grade 2 and above according to the criteria published byMoreau
Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2participants.
Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathyaccording to the West-Haven classification, unable to give consent.
Participants with active hepatocellular carcinoma (HCC) or history of HCC that is inremission for less than six months for uninodular HCC or for less than 12 months formultinodular HCC within Milan criteria.
Participants with a history of significant extra hepatic disease with impairedshort-term prognosis, including congestive heart failure New York Heart AssociationGrade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL orunder renal replacement therapy.
Participants with documented refractory ascites
Participants who are active on the transplant waiting list.
Participants with current extra hepatic malignancies including solid tumours andhematologic disorders.
Participants with mental incapacity, significant language barriers, or any otherreason considered by the investigator precluding adequate understanding, cooperationor compliance in the study.
Participants with active viral infections, or yet to achieve clear response toanti-viral therapy.
Any disorders likely to impact on study engagement, including severe frailty, severeaddiction history (including opioids) with evidence of multiple recent relapses.
Any other reason that the PI considers would make the participant unsuitable toenter CirrhoCare (e.g., participants on an end-of-life palliative care pathway).
Participants enrolled in other interventional trials.
Study Design
Study Description
Connect with a study center
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW
United KingdomActive - Recruiting
Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 5BE
United KingdomActive - Recruiting
Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX
United KingdomActive - Recruiting
Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
Liverpool, L7 8YE
United KingdomActive - Recruiting
King's College Hospital, King's College Hospital NHS Foundation Trust
London, SE5 9RS
United KingdomActive - Recruiting
Royal Free Hospital, Royal Free London NHS Foundation Trust
London, NW3 2QG
United KingdomActive - Recruiting
St George's Hospital, St George's university Hospital NHS Foundation Trust
London, SW17 0QT
United KingdomActive - Recruiting
St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust
London, SE1 7EH
United KingdomSite Not Available
The Royal London Hospital, Barts Health NHS Trust
London, E1 1FR
United KingdomActive - Recruiting
Whittington Hospital, Whittington Health NHS Trust
London, N19 5NF
United KingdomActive - Recruiting
Queen's Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
United KingdomActive - Recruiting
John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
United KingdomActive - Recruiting
Derriford Hospital, University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH
United KingdomActive - Recruiting
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
United KingdomActive - Recruiting
Torbay Hospital, Torbay and South Devon NHS Foundation Trust
Torquay, TQ2 7AA
United KingdomActive - Recruiting
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