At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Observational Protocol (other)
- How long the study runs
- Study runs about 65 months (dates as stated)
- About the drug or intervention
- Observational Protocol — other: The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at liver transplants in adults with cirrhosis (scarring of the liver) and a severe sudden worsening called acute-on-chronic liver failure (ACLF). It is run by the European Foundation for Study of Chronic Liver Failure. It includes people put forward for a transplant with ACLF grade 2 or 3, people listed with very poor liver function but without ACLF grade 2 or 3, and people with ACLF grade 2 or 3 who were assessed but not put on the transplant list.
Who can take part
- Adults aged 18 or over, male or female
- People diagnosed with liver cirrhosis, based on tests, scans, or tissue samples
- People in hospital for a sudden worsening of cirrhosis and referred to the transplant team, in one of three groups: listed for transplant with ACLF grade 2 or 3; listed with poor liver function (MELD score above 20) but without ACLF grade 2 or 3; or assessed but not put on the transplant list
- The patient, or a trusted person, family member, or close relation if the patient cannot consent, has given informed written consent
Who may not be able to
- Not stated — ask the trial team
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 3,000
- Started
- 2021-07-08
- Last checked
- 2025-10
Plain English Summary
What is this study?
- • Testing a new treatment for liver diseases
- • Clinical study - 3,000 participants
- • Management of ACLF is mainly supportive
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with liver diseases
Where?
- • Birmingham - Queen Elizabeth Hospital Birmingham
- • Edinburgh - Scottish Liver Transplant Unit, Royal Infirmary
- • Leeds - Leeds Teaching Hospitals NHS Trust
- • London - King's College Hospital
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.
More detail
The aim of this study is to compare 1-year graft and patient survival rates after liver transplantation (LT) in patients with ACLF-2 or 3 at the time of LT, with patients with decompensated cirrhosis without ACLF-2 or 3 at the time of LT and also with transplant-free survival of patients with ACLF-2 or 3 not listed for LT. Secondary objectives are as follows: * To assess the proportion of patients with ACLF-2 or 3 referred to transplant team who are listed or not and reasons of this decision. * To evaluate the outcomes of patients listed with ACLF-2 or 3 on the waiting list compared with those of patients listed with decompensated cirrhosis without ACLF-2 or 3. * To define independent predictive factors of death/delisting on the waiting list for patients listed with ACLF-2 or 3 and develop a new prognostic model based on ACLF criteria to predict mortality on the waiting list and to improve the allocation of organs. * To compare the characteristics of accepted grafts for patients listed with ACLF-2 or 3 with those of patients listed with decompensated cirrhosis without ACLF-2 or 3 and their impact on post-LT outcomes. * To explore independent predictive factors of death after LT for patients transplanted with ACLF-2 or 3 to design futility criteria for LT. * To compare post-LT survival rates of patients with ACLF-2 or 3 at listing and patients without ACLF at listing who develop ACLF-2 or 3 on the waiting list. * To compare post-LT quality of life (QoL) for patients listed with ACLF-2 or 3 with those of patients listed with decompensated cirrhosis without ACLF-2 or 3.
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 - 80 Years
- Who can join: All genders
What the study is looking for
- ✓1\. Male or female subject ≥18 years of age.
- ✓2\. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic...
- ✓3\. Subjects who have been hospitalized for acute decompensation of liver cirrhosis and referred to the transplant team:
- ✓Group 1: patients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3...
- ✓Group 2: patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver...
See the full criteria
Where Is This Study? (5 UK sites)
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Scottish Liver Transplant Unit, Royal Infirmary
Edinburgh, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
King's College Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
How to Get in Touch
Anna Bosch
Sponsor contactCONTACT