At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- CirrhoCare management system (device)
- How long the study runs
- Study runs about 38 months (dates as stated)
- About the drug or intervention
- CirrhoCare management system — device: This is a UKCA-marked, digital-therapeutic system consisting of: * clinical-grade, cirrhosis monitoring sensors and a smartphone app, * a clinical team-facing, decision-facilitating dashboard, and * CyberLiver's platform incorporating hepatic algorithms.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 214
- Started
- 2023-11-24
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for decompensated cirrhosis
- • NA - 214 participants
- • The CirrhoCare trial is a multi-centre, open label randomised controlled trial in patients with decompensated cirrhosis
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with decompensated cirrhosis
Where?
- • Birmingham - Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
- • Brighton - Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
- • Coventry - Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
- • Liverpool - Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
- • +11 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Cirrhosis, progressive scaring of the liver- has many causes, principally, excessive alcohol intake, fatty-liver and viral infections. Unlike many chronic diseases, cirrhosis deaths are increasing rapidly year-on-year. It is the third commonest cause of premature, UK working-age deaths, with 62,000 years of working-life lost each year and NHS care costs of £4.53bn annually. One quarter of all UK cirrhosis patients are at-risk of acute decompensation, whereby complications such as fluid-overload, confusion and infections arise, requiring hospital-emergency treatment. Currently, decompensated cirrhosis patients require regular hospital clinical assessments to detect these new complications. Even following hospital discharge, readmission with new decompensating complications approaches 37% in 4 weeks. This disease burden, compounded by increasing alcohol and obesity-driven liver disease, means demand for specialist liver services outweighs current capacity in a resource-stretched healthcare system. Moreover, regional variation of specialist liver services also impacts on illness and deaths, leading to a postcode lottery of care access and geographical inequity. The CirrhoCare trial, addresses this urgent clinical-need through an innovative cirrhosis management system, including home-monitoring of decompensated cirrhosis patients, measuring vital signs such as heart rate and blood pressure (using low cost, sensing technology), assessing weight (smart-scale) and mental ability (smartphone app), all of which are impacted as cirrhosis progresses. By efficiently and securely collecting data on CyberLiver's management-system (platform), CirrhoCare provides a decision-facilitating tool, incorporating individual-patient data, helping liver-physicians to optimise and personalise treatment in the community. The CirrhoCare trial investigators also plan to assess clinical and cost effectiveness of CirrhoCare management and seek regulatory approvals. This innovative aspect of cirrhosis management will be more acceptable and convenient for patients. It will also deliver community care with environmental, sustainable benefits, through reduced hospital visits, despite increasing service demands. The cost- effectiveness analysis will generate value-for-money evidence of CirrhoCare management, and the clinical evidence needed to inform future adoption into the NHS.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
- ✓Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C...
- ✓Participants able to give agreement to take part.
Who cannot take part
- ✗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 liver encephalopathy, defined as grade II-IV liver encephalopathy according to the West-Haven...
- ✗Participants with documented refractory ascites on a palliative pathway.
- ✗Participants who are active on the transplant waiting list.
See the full criteria
Where Is This Study? (15 UK sites)
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham B15 2GW, United Kingdom
Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
Brighton BN2 5BE, United Kingdom
Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
Coventry CV2 2DX, United Kingdom
Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
Liverpool L7 8YE, United Kingdom
The Royal London Hospital, Barts Health NHS Trust
London E1 1FR, United Kingdom
Whittington Hospital, Whittington Health NHS Trust
London N19 5NF, United Kingdom
Royal Free Hospital, Royal Free London NHS Foundation Trust
London NW3 2QG, United Kingdom
St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust
London SE1 7EH, United Kingdom
King's College Hospital, King's College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
St George's Hospital, St George's university Hospital NHS Foundation Trust
London SW17 0QT, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham NG7 2UH, United Kingdom
John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford OX3 9DU, United Kingdom
Derriford Hospital, University Hospitals Plymouth NHS Trust
Plymouth PL6 8DH, United Kingdom
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
Torbay Hospital, Torbay and South Devon NHS Foundation Trust
Torquay TQ2 7AA, United Kingdom
How to Get in Touch
Tasheeka Jeyapalan
Sponsor contactCONTACT
