Recruiting

Liver Transplantation

Sponsor:

European Foundation for Study of Chronic Liver Failure

Code:

NCT04613921

Conditions

Liver Diseases

Liver Cirrhosis

Acute-On-Chronic Liver Failure

Liver Transplant; Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Observational Protocol

Study Details

Brief summary:

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.

Conditions

Liver Diseases

Liver Cirrhosis

Acute-On-Chronic Liver Failure

Liver Transplant; Complications

Study ID

NCT04613921

Start date

Jul 8, 2021

Status verified date

Oct, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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:

\-

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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 (n=2,000)

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 (n=500)

Group 3

patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation (n=500)

Interventions

Observational Protocol

The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)

Primary outcome measure

  • Survival [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Anna Bosch

34 93 227 1400anna.bosch@efclif.com

Locations

Cedars-Sinai Comprehensive Transplant Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Alexander Kuo

Alexander.Kuo@cshs.org

Principal Investigator:

Alexander Kuo

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Michael Kriss

303-724-1030michael.kriss@cuanschutz.edu

Principal Investigator:

Michael Kriss

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Lance Stein

lance.stein@piedmont.org

Principal Investigator:

Lance Stein

The University of Chicago Medicine

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Helen Te

hte@medicine.bsd.uchicago.edu

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kirti Shetty

410 3281328kshetty@som.umaryland.edu

Principal Investigator:

Kirti Shetty

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Russell Rosenblatt

646-962-5483rur9017@med.cornell.edu

Principal Investigator:

Russell Rosenblatt

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029-5674

Contacts

Ghideon Ezaz

ghideon.ezaz@mountsinai.org

Principal Investigator:

Ghideon Ezaz

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Bijan Eghtesad

eghtesb@ccf.org

Principal Investigator:

Bijan Eghtesad

Baylor St. Luke's Medical Centre

Recruiting

Houston, Texas, United States, 77030

Contacts

Jalal Prasun

jalal@bcm.edu

Principal Investigator:

Jalal Prasun

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Juan Gallegos-Orozco

801.581.7878juan.gallegos@hsc.utah.edu

Principal Investigator:

Juan Gallego-Orozco

University of Alberta

Recruiting

Edmonton, Canada

Contacts

Dean Karvellas

Cjk2@ualberta.ca

University of Toronto, Multiorgan Transplant Program

Recruiting

Toronto, Canada

Contacts

Nazia Selzner

Nazia.selzner@uhn.ca

More Information

Sponsor

European Foundation for Study of Chronic Liver Failure

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by European Foundation for Study of Chronic Liver Failure on 2025-10-20.