RecruitingNCT04613921

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

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


Sponsor

European Foundation for Study of Chronic Liver Failure

Enrollment

3,000 participants

Start Date

Jul 8, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • \. 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.

Exclusion Criteria1

  • \-

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Interventions

OTHERObservational Protocol

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


Locations(106)

Cedars-Sinai Comprehensive Transplant Center

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

Tampa General Hospital

Tampa, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

The University of Chicago Medicine

Chicago, Illinois, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Weill Cornell Medicine

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine (Scott & White)

Dallas, Texas, United States

Michael E DeBakey VA Medical Center

Houston, Texas, United States

Baylor St. Luke's Medical Centre

Houston, Texas, United States

University of Utah Health

Salt Lake City, Utah, 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, 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

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