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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
CirrhoCare
Trial
None available
cctu.cirrhocare@ucl.ac.uk
Prof
Rajeshwar
Mookerjee
+44 (0)207 794 0500
r.mookerjee@ucl.ac.uk
Complications of cirrhosis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Cirrhosis, progressive scarring 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 most common 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. This describes the development of acute complications such as fluid overload, confusion and infections, requiring hospital admissions and often urgent treatment. Currently, cirrhosis patients deemed at risk of decompensation 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 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 study will also assess the 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. 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 01/05/2025:
1. Adults ≥18 years and diagnosed with cirrhosis of any aetiology.
2. 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 stable corticosteroid dose for ≥3-month period before study inclusion (to be recorded on concomitant log).
3. 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.
4. 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)].
5. Participants able to give informed con
You may not be able to take part if:
Current exclusion criteria as of 01/05/2025:1. Participants with ACLF grade 2 and above according to the criteria published by Moreau2. Participants with CLIF-C AD score ≥66, who have a high mortality similar to ACLF ≥2 participants 3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent4. Participants with active hepatocellular carcinoma (HCC) or a history of HCC that is in remission for less than 6 months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria5. Participants with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV 5, COPD GOLD >2, chronic kidney disease with serum creatinine >2 mg/dL or under renal replacement therapy6. Participants with documented refractory ascites - added 23/05/2025: on a palliative pathway7. Participants who are active on the transplant waiting list8. Participants with current extrahepatic malignancies, including solid tumours and hematologic disorders.9. Participants with mental incapacity, significant language barrier, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study10. Participants with active viral infections, or yet to achieve a clear response to anti-viral therapy11. Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses12. Any other reason that the PI considers would make the participant unsuitable to enter CirrhoCare (e.g., participants on an end-of-life palliative care pathway)13. Participants enrolled in other interventional trials
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Previous exclusion criteria as of 05/02/2025:
1. Participants with ACLF grade 2 and above according to the criteria published by Moreau.2. Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent.4. Participants with active hepatocellular carcinoma (HCC) or a 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.5. Participants with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.6. Participants with documented refractory ascites7. Participants who are active on the transplant waiting list.8. Participants with current extrahepatic malignancies including solid tumours and hematologic disorders.9. Participants with mental incapacity, significant language barriers, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.10. Participants with active viral infections, or yet to achieve clear response to anti-viral therapy.11. Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses.12. Any other reason that the PI considers would make the participant unsuitable to enter CirrhoCare (e.g., participants on an end-of-life palliative care pathway).13. Participants enrolled in other interventional trials.
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Original exclusion criteria:
1. Participants with acute-on-chronic liver failure (ACLF) grade 2 and above according to the criteria 2. Participants with CLIF-C AD score > = 60, who have a mortality similar to ACLF > = 2 participants3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent4. Participants with active hepatocellular carcinoma (HCC) or a 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 criteria5. Participants with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV (New York Heart Association Criteria Committee, 1979), COPD GOLD > 2, chronic kidney disease with serum creatinine > 2mg/dL or under renal replacement therapy6. Refractory ascites, and who are being considered for liver transplantation listing7. Participants with current extrahepatic malignancies, including solid tumours and hematologic disorders8. Participants with mental incapacity, language barrier, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study (e.g., severe addiction and relapse history)9. Participants with active viral infections, or yet to achieve clear response to anti-viral therapy. 10. Any disorders likely to impact on study engagement, including severe frailty, and severe addiction history (including opioids) with evidence of multiple relapses. 11. Any other reason that the PI considers would make the participant unsuitable to enter CirrhoCare (e.g. participants on an end-of-life palliative care pathway)12. Refusal or inability to give informed consent13. Participants enrolled in other interventional trials
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Rajeshwar
Mookerjee
+44 (0)207 794 0500
r.mookerjee@ucl.ac.uk
Dr
CirrhoCare
Trial
None available
cctu.cirrhocare@ucl.ac.uk
The study is sponsored by University College London and funded by National Institute for Health and Care Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 57442
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