Last updated: January 16, 2024
Sponsor: University College, London
Overall Status: Active - Recruiting
Phase
N/A
Condition
Scar Tissue
Hepatic Fibrosis
Hyponatremia
Treatment
CirrhoCare management system
Clinical Study ID
NCT06223893
151197
Ages > 18 All Genders Accepts Healthy Volunteers
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 stable corticosteroid dose for ≥3-month period before study inclusion.
- Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure -Acute Decompensation score (CLIF-C AD score) ≥45 but <60 points at the time ofscreening.
- Hospitalisation for acute decompensation (determined as one or more of the following:increasing ascites, portal hypertensive-related bleeding, overt hepaticencephalopathy, new infection).
- Participants able to give informed consent.
Exclusion
Exclusion Criteria:
- Participants with ACLF grade 2 and above according to the criteria published by Moreau 1
- Participants with CLIF-C AD score ≥ 60, who have a high mortality similar to ACLF ≥2participants. 2
- Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathyaccording to the West-Haven classification 3, 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 4, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL orunder renal replacement therapy.
- Participants with documented refractory ascites, and who are being considered forliver transplantation listing.
- Participants with current extra hepatic malignancies including solid tumours andhematologic disorders.
- Participants with mental incapacity, language barrier, or any other reason consideredby the investigator precluding adequate understanding, cooperation or compliance inthe study (e.g., severe addiction and relapse history).
- 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 relapses.
- Any other reason that the PI considers would make the participant unsuitable to enterCirrhoCare (e.g., participants on an end-of-life palliative care pathway).
- Refusal or inability to give informed consent.
- Participants enrolled in other interventional trials.
Study Design
Total Participants: 214
Treatment Group(s): 1
Primary Treatment: CirrhoCare management system
Phase:
Study Start date:
November 24, 2023
Estimated Completion Date:
May 31, 2025
Study Description
Connect with a study center
Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX
United KingdomSite Not Available
Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
Liverpool, L7 8YE
United KingdomSite Not Available
King's College Hospital, King's College Hospital NHS Foundation Trust
London, SE5 9RS
United KingdomSite Not Available
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 KingdomSite Not Available
St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust
London, SE1 7EH
United KingdomSite Not Available
John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
United KingdomSite Not Available
Derriford Hospital, University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH
United KingdomSite Not Available
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
United KingdomSite Not Available
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