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

Last updated: August 27, 2024
Sponsor: European Foundation for Study of Chronic Liver Failure
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatic Fibrosis

Scar Tissue

Hyponatremia

Treatment

Observational Protocol

Clinical Study ID

NCT04613921
2020/01325
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 cirrhosisand referred to the transplant team:

  • Group 1: patients listed for liver transplantation with ACLF-2 or 3 at the time oflisting or developing ACLF 2-3 while on the waiting list.

  • Group 2: patients listed for liver transplantation with decompensated cirrhosiswithout 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 waitinglist, but are finally not listed for liver transplantation.

  1. Patients (or trusted person, family member or close relation if the patient isunable to express consent) who have been informed and signed their informedconsent Inclusion criteria

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: Observational Protocol
Phase:
Study Start date:
July 08, 2021
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Austral University Hospital

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Hospital Alemán

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Italian Hospital in Buenos Aires

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Austin Hospital

    Heidelberg,
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands,
    Australia

    Suspended

  • Royal Prince Alfred Hospital

    Sydney,
    Australia

    Active - Recruiting

  • Medical University of Graz

    Graz,
    Austria

    Site Not Available

  • Medical University of Vienna, Department of Transplant Surgery

    Wien,
    Austria

    Active - Recruiting

  • CUB Erasme Hospital

    Brussels,
    Belgium

    Active - Recruiting

  • Ghent University Hospital

    Ghent,
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • Walter Cantídio University Hospital

    Fortaleza,
    Brazil

    Active - Recruiting

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre,
    Brazil

    Active - Recruiting

  • Hospital das Clínicas da Universidade de São Paulo

    São Paulo,
    Brazil

    Active - Recruiting

  • University of Alberta

    Edmonton,
    Canada

    Active - Recruiting

  • University of Toronto, Multiorgan Transplant Program

    Toronto,
    Canada

    Active - Recruiting

  • Pablo Tobón Uribe Hospital

    Medellín,
    Colombia

    Active - Recruiting

  • Institute for Clinical and Experimental Medicine

    Praha,
    Czechia

    Site Not Available

  • APHP Beaujon

    Clichy,
    France

    Active - Recruiting

  • APHP Henri Mondor

    Créteil,
    France

    Active - Recruiting

  • Hôpital de la Croix-Rousse

    Lyon,
    France

    Active - Recruiting

  • CHU Montpellier-Hôpital Saint Eloi

    Montpellier,
    France

    Active - Recruiting

  • APHP Hôpitaux Universitaires Pitié Salpêtrière

    Paris,
    France

    Active - Recruiting

  • CHU Rennes, Hôpital De Pontchaillou

    Rennes,
    France

    Active - Recruiting

  • Hautepièrre Hospital, Service de Réanimation Médicale

    Strasbourg,
    France

    Active - Recruiting

  • Trousseau Hospital,

    Tours,
    France

    Active - Recruiting

  • Hôpital Paul Brousse

    Villejuif,
    France

    Active - Recruiting

  • University Hospital Regensburg

    Regensburg, Eastern Bavaria
    Germany

    Site Not Available

  • University Hospital Aachen

    Aachen,
    Germany

    Suspended

  • Charité University Hospital

    Berlin,
    Germany

    Active - Recruiting

  • Goethe University Clinic

    Frankfurt,
    Germany

    Site Not Available

  • University Medical Center, Hamburg Eppendorf

    Hamburg,
    Germany

    Active - Recruiting

  • Hannover Medical School

    Hannover,
    Germany

    Site Not Available

  • University Hospital Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • Jena University Hospital

    Jena,
    Germany

    Suspended

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    Kiel,
    Germany

    Active - Recruiting

  • Leipzig University Hospital

    Leipzig,
    Germany

    Site Not Available

  • University Hospital Mainz

    Mainz,
    Germany

    Suspended

  • LMU Großhadern

    Munich,
    Germany

    Suspended

  • UKM Muenster

    Münster,
    Germany

    Active - Recruiting

  • University Hospital Tübingen

    Tübingen,
    Germany

    Active - Recruiting

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong,
    Hong Kong

    Suspended

  • Indraprastha Apollo Hospitals

    New Delhi, Delhi
    India

    Site Not Available

  • Aster CMI Hospital

    Bengaluru, Karnataka
    India

    Site Not Available

  • Kasturba Hospital

    Mumbai, Maharashtra
    India

    Site Not Available

  • Seth GSMC & KEM Hospital

    Mumbai, Maharashtra
    India

    Site Not Available

  • Mahatma Gandhi University of Medical Sciences and Technology

    Jaipur, Rajasthan
    India

    Site Not Available

  • Dr.Rela Institute & Medical Centre

    Chennai,
    India

    Active - Recruiting

  • Fortis Hospital Noida, FEHI, FMRI

    Gurugramam,
    India

    Site Not Available

  • Medanta Medicity

    Gurugramam,
    India

    Site Not Available

  • Amrita Institute of Medical Sciences

    Kochi,
    India

    Active - Recruiting

  • Global Hospital. Super speciality & transplant centre

    Mumbai,
    India

    Site Not Available

  • Max Saket Hospital

    New Delhi,
    India

    Site Not Available

  • Yashoda Hospitals

    Secunderabad,
    India

    Site Not Available

  • Ospedale Papa Giovanni XXIII-

    Bergamo,
    Italy

    Site Not Available

  • S.Orsola Hospital - Alma Mater Studiorum University of Bologna

    Bologna,
    Italy

    Active - Recruiting

  • Ca' Granda. Policlinico Milano

    Milan,
    Italy

    Active - Recruiting

  • Niguarda Hospital

    Milan,
    Italy

    Active - Recruiting

  • University and Hospital of Padova

    Padova,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa,
    Italy

    Site Not Available

  • Kyushu University Hospital

    Fukuoka,
    Japan

    Active - Recruiting

  • Hiroshima University Hospital

    Hiroshima,
    Japan

    Active - Recruiting

  • Kyoto University Hospital

    Kyoto,
    Japan

    Active - Recruiting

  • Nagasaki University Hospital

    Nagasaki,
    Japan

    Active - Recruiting

  • Tokyo University Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City,
    Mexico

    Active - Recruiting

  • University Medical Center Groningen (UMCG)

    Groningen,
    Netherlands

    Site Not Available

  • Erasmus MC University Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Auckland City Hospital- New Zealand Liver Transplant Unit

    Auckland,
    New Zealand

    Suspended

  • Guillermo Almenara National Hospital

    Lima,
    Peru

    Site Not Available

  • Medical University of Warsaw, Dept. of General, Transplant & Liver Surgery

    Warsaw,
    Poland

    Active - Recruiting

  • Hospital Curry Cabral

    Lisboa,
    Portugal

    Active - Recruiting

  • Hospital Clinic in Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Vall d'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Marqués de Valdecilla

    Santander,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia,
    Spain

    Active - Recruiting

  • Karolinska Institutet

    Stockholm, 171 77
    Sweden

    Active - Recruiting

  • Geneva University Hospital (HUG)

    Geneva,
    Switzerland

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung,
    Taiwan

    Active - Recruiting

  • Inonu University, Liver Transplantation Institute

    Malatya, Anatolia
    Turkey

    Active - Recruiting

  • Istanbul Memorial Bahcelievler Hospital

    Istanbul,
    Turkey

    Suspended

  • Queen Elizabeth Hospital Birmingham

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Scottish Liver Transplant Unit, Royal Infirmary

    Edinburgh,
    United Kingdom

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds,
    United Kingdom

    Active - Recruiting

  • King's College Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Cedars-Sinai Comprehensive Transplant Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Piedmont Healthcare

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • The University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029-5674
    United States

    Active - Recruiting

  • Montefiore Medical Center

    New York, New York 10467
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10021
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Suspended

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Suspended

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Baylor College of Medicine (Scott & White)

    Dallas, Texas 75246
    United States

    Site Not Available

  • Baylor St. Luke's Medical Centre

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Michael E DeBakey VA Medical Center

    Houston, Texas 77030-4211
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

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