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

Recruiting now

Conditions studied: Liver Diseases, Liver Cirrhosis, Acute-On-Chronic Liver Failure, Liver Transplant; Complications

In brief

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.

Key facts

Study ID

NCT04613921

Run by

European Foundation for Study of Chronic Liver Failure

People needed

3000

Starts

2021-07-08

Expected to finish

2026-12-31

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Male or female subject ≥18 years of age.
• Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
• 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.
• 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

Where it is running

• Irmandade Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Brazil (enrolling)
• University of Toronto, Multiorgan Transplant Program — Toronto, Canada (enrolling)
• CUB Erasme Hospital — Brussels, Belgium (enrolling)
• Walter Cantídio University Hospital — Fortaleza, Brazil (enrolling)
• Cedars-Sinai Comprehensive Transplant Center — Los Angeles, California, United States (enrolling)
• University of Alberta — Edmonton, Canada (enrolling)
• Piedmont Healthcare — Atlanta, Georgia, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• The University of Chicago Medicine — Chicago, Illinois, United States (enrolling)
• University of Maryland School of Medicine — Baltimore, Maryland, United States (enrolling)
• Hospital das Clínicas da Universidade de São Paulo — São Paulo, Brazil (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Baylor St. Luke's Medical Centre — Houston, Texas, United States (enrolling)
• University of Utah Health — Salt Lake City, Utah, United States (enrolling)
• Austral University Hospital — Buenos Aires, Argentina (enrolling)
• Hospital Alemán — Buenos Aires, Argentina (enrolling)
• Italian Hospital in Buenos Aires — Buenos Aires, Argentina (enrolling)
• Austin Hospital — Heidelberg, Australia (enrolling)
• Ghent University Hospital — Ghent, Belgium (enrolling)
• Royal Prince Alfred Hospital — Sydney, Australia (enrolling)
• Medical University of Vienna, Department of Transplant Surgery — Vienna, Austria (enrolling)
• Pablo Tobón Uribe Hospital — Medellín, Colombia (enrolling)

Full record on ClinicalTrials.gov

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