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Liver transplantation outcomes for patients with severe liver failure

Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs

Observational European Foundation for Study of Chronic Liver Failure · NCT04613921

This study is testing how well liver transplants work for people with severe liver failure compared to those with advanced cirrhosis to see which group has better survival rates and quality of life after the transplant.

Quick facts

Study typeObservational
Enrollment3000 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorEuropean Foundation for Study of Chronic Liver Failure Academic / other
Locations106 sites (Los Angeles, California and 105 other locations)
Trial IDNCT04613921 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the one-year graft and patient survival rates after liver transplantation in patients with severe acute-on-chronic liver failure (ACLF-2 or 3) against those with decompensated cirrhosis without ACLF. It will also evaluate the transplant-free survival of patients with ACLF who are not listed for transplantation. Secondary objectives include assessing the reasons for listing decisions, outcomes of patients on the waiting list, and developing a prognostic model to predict mortality on the waiting list. The study will explore independent predictive factors of death after transplantation and compare post-transplant survival rates and quality of life between the two groups.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with liver cirrhosis who have been hospitalized for acute decompensation and are either listed for transplantation with ACLF-2 or 3 or assessed for listing but not listed.

Not a fit: Patients with liver cirrhosis who do not have ACLF or those who are not hospitalized for acute decompensation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the understanding of liver transplantation outcomes for patients with severe liver failure, potentially leading to better patient selection and management strategies.

How similar studies have performed: While there have been studies on liver transplantation in patients with cirrhosis, this specific focus on ACLF-2 or 3 is less common, making this approach relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 1\. Male or female subject ≥18 years of age.

  2\. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).

  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 while on the waiting list.
* Group 2: patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD\>20) at the time of listing.
* Group 3: patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation.

  4\. Patients (or trusted person, family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent Inclusion criteria

Exclusion Criteria:

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Where this trial is running

Los Angeles, California and 105 other locations

+56 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Liver DiseasesLiver CirrhosisAcute-On-Chronic Liver FailureLiver TransplantComplications
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.