Liver transplantation outcomes for patients with severe liver failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cedars-Sinai Comprehensive Transplant Center
  Los Angeles, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting
• Piedmont Healthcare
  Atlanta, Georgia, United States Recruiting
• The University of Chicago Medicine
  Chicago, Illinois, United States Recruiting
• University of Maryland School of Medicine
  Baltimore, Maryland, United States Recruiting
• Weill Cornell Medicine
  New York, New York, United States Recruiting

+56 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Anna Bosch
• Email: anna.bosch@efclif.com
• Phone: 34 93 227 1400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.