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NCT04613921Recruiting

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

European Foundation for Study of Chronic Liver Failure

Start Date

7/8/2021

Completion Date

12/31/2026

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 80 years

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: \-

Interventions

OTHER

Observational Protocol

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Conditions

Liver DiseasesLiver CirrhosisAcute-On-Chronic Liver FailureLiver Transplant; Complications

Locations

Cedars-Sinai Comprehensive Transplant Center

Los Angeles, California 90048

United States

University of Colorado

Aurora, Colorado 80045

United States

Tampa General Hospital

Tampa, Florida 33606

United States

Piedmont Healthcare

Atlanta, Georgia 30309

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

The University of Chicago Medicine

Chicago, Illinois 60637

United States

University of Maryland School of Medicine

Baltimore, Maryland 21201

United States

Weill Cornell Medicine

New York, New York 10021

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029-5674

United States

Montefiore Medical Center

New York, New York 10467

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Baylor College of Medicine (Scott & White)

Dallas, Texas 75246

United States

Michael E DeBakey VA Medical Center

Houston, Texas 77030-4211

United States

Baylor St. Luke's Medical Centre

Houston, Texas 77030

United States

University of Utah Health

Salt Lake City, Utah 84132

United States

Austral University Hospital

Buenos Aires,

Argentina

Hospital Alemán

Buenos Aires,

Argentina

Italian Hospital in Buenos Aires

Buenos Aires,

Argentina

Austin Hospital

Heidelberg,

Australia

Sir Charles Gairdner Hospital

Nedlands,

Australia

Royal Prince Alfred Hospital

Sydney,

Australia

Medical University of Vienna, Department of Transplant Surgery

Vienna,

Austria

CUB Erasme Hospital

Brussels,

Belgium

Ghent University Hospital

Ghent,

Belgium

UZ Leuven

Leuven,

Belgium

Walter Cantídio University Hospital

Fortaleza,

Brazil

Irmandade Santa Casa de Misericórdia de Porto Alegre

Porto Alegre,

Brazil

Hospital das Clínicas da Universidade de São Paulo

São Paulo,

Brazil

University of Alberta

Edmonton,

Canada

University of Toronto, Multiorgan Transplant Program

Toronto,

Canada

Pablo Tobón Uribe Hospital

Medellín,

Colombia

Institute for Clinical and Experimental Medicine

Prague,

Czechia

APHP Beaujon

Clichy,

France

APHP Henri Mondor

Créteil,

France

Hôpital de la Croix-Rousse

Lyon,

France

CHU Montpellier-Hôpital Saint Eloi

Montpellier,

France

APHP Hôpitaux Universitaires Pitié Salpêtrière

Paris,

France

CHU Rennes, Hôpital De Pontchaillou

Rennes,

France

Hautepièrre Hospital, Service de Réanimation Médicale

Strasbourg,

France

Trousseau Hospital,

Tours,

France

Hôpital Paul Brousse

Villejuif,

France

University Hospital Regensburg

Regensburg, Eastern Bavaria

Germany

Universitätsklinikum Schleswig-Holstein (UKSH)

Kiel, Schleswig-Holstein

Germany

University Hospital Aachen

Aachen,

Germany

Charité University Hospital

Berlin,

Germany

Goethe University Clinic

Frankfurt,

Germany

University Medical Center, Hamburg Eppendorf

Hamburg,

Germany

Hannover Medical School

Hanover,

Germany

University Hospital Heidelberg

Heidelberg,

Germany

Jena University Hospital

Jena,

Germany

Universitätsklinikum Schleswig-Holstein (UKSH)

Kiel,

Germany

Leipzig University Hospital

Leipzig,

Germany

University Hospital Mainz

Mainz,

Germany

LMU Großhadern

Munich,

Germany

UKM Muenster

Münster,

Germany

University Hospital Tübingen

Tübingen,

Germany

Queen Mary Hospital, The University of Hong Kong

Hong Kong,

Hong Kong

Aster CMI Hospital

Bengaluru, Karnataka

India

Kasturba Hospital

Mumbai, Maharashtra

India

Seth GSMC & KEM Hospital

Mumbai, Maharashtra

India

Indraprastha Apollo Hospitals

New Delhi, National Capital Territory of Delhi

India

Mahatma Gandhi University of Medical Sciences and Technology

Jaipur, Rajasthan

India

Dr.Rela Institute & Medical Centre

Chennai,

India

Fortis Hospital Noida, FEHI, FMRI

Gurugramam,

India

Medanta Medicity

Gurugramam,

India

Amrita Institute of Medical Sciences

Kochi,

India

Global Hospital. Super speciality & transplant centre

Mumbai,

India

Max Saket Hospital

New Delhi,

India

Yashoda Hospitals

Secunderabad,

India

Ospedale Papa Giovanni XXIII-

Bergamo,

Italy

S.Orsola Hospital - Alma Mater Studiorum University of Bologna

Bologna,

Italy

Ca' Granda. Policlinico Milano

Milan,

Italy

Niguarda Hospital

Milan,

Italy

University and Hospital of Padova

Padova,

Italy

Kyushu University Hospital

Fukuoka,

Japan

Hiroshima University Hospital

Hiroshima,

Japan

Kyoto University Hospital

Kyoto,

Japan

Nagasaki University Hospital

Nagasaki,

Japan

Tokyo University Hospital

Tokyo,

Japan

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City,

Mexico

University Medical Center Groningen (UMCG)

Groningen,

Netherlands

Erasmus MC University Medical Center

Rotterdam,

Netherlands

Auckland City Hospital- New Zealand Liver Transplant Unit

Auckland,

New Zealand

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

Warsaw,

Poland

Hospital Curry Cabral

Lisbon,

Portugal

Samsung Medical Center

Seoul,

South Korea

Hospital Clinic in Barcelona

Barcelona,

Spain

Hospital Vall d'Hebron

Barcelona,

Spain

Hospital Universitario 12 de Octubre

Madrid,

Spain

Hospital Universitario Ramón y Cajal

Madrid,

Spain

Hospital Marqués de Valdecilla

Santander,

Spain

Hospital Universitario Virgen del Rocío

Seville,

Spain

Hospital Universitari i Politècnic La Fe

Valencia,

Spain

Karolinska Institutet

Stockholm, Stockholm County 171 77

Sweden

Geneva University Hospital (HUG)

Geneva,

Switzerland

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City,

Taiwan

Inonu University, Liver Transplantation Institute

Malatya, Anatolia

Turkey (Türkiye)

Istanbul Memorial Bahcelievler Hospital

Istanbul,

Turkey (Türkiye)

Queen Elizabeth Hospital Birmingham

Birmingham,

United Kingdom

Scottish Liver Transplant Unit, Royal Infirmary

Edinburgh,

United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds,

United Kingdom

King's College Hospital

London,

United Kingdom

Royal Free Hospital

London,

United Kingdom