Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs
NCT ID: NCT04613921
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2021-07-08
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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)
Observational Protocol
The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)
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)
Observational Protocol
The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)
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)
Observational Protocol
The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)
Interventions
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Observational Protocol
The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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European Foundation for Study of Chronic Liver Failure
OTHER
Responsible Party
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Locations
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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
Padua, , 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
Countries
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Central Contacts
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Facility Contacts
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Arvinder Singh Soin
Role: primary
References
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Gustot T, Fernandez J, Garcia E, Morando F, Caraceni P, Alessandria C, Laleman W, Trebicka J, Elkrief L, Hopf C, Solis-Munoz P, Saliba F, Zeuzem S, Albillos A, Benten D, Montero-Alvarez JL, Chivas MT, Concepcion M, Cordoba J, McCormick A, Stauber R, Vogel W, de Gottardi A, Welzel TM, Domenicali M, Risso A, Wendon J, Deulofeu C, Angeli P, Durand F, Pavesi M, Gerbes A, Jalan R, Moreau R, Gines P, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Clinical Course of acute-on-chronic liver failure syndrome and effects on prognosis. Hepatology. 2015 Jul;62(1):243-52. doi: 10.1002/hep.27849. Epub 2015 May 29.
Artru F, Louvet A, Ruiz I, Levesque E, Labreuche J, Ursic-Bedoya J, Lassailly G, Dharancy S, Boleslawski E, Lebuffe G, Kipnis E, Ichai P, Coilly A, De Martin E, Antonini TM, Vibert E, Jaber S, Herrerro A, Samuel D, Duhamel A, Pageaux GP, Mathurin P, Saliba F. Liver transplantation in the most severely ill cirrhotic patients: A multicenter study in acute-on-chronic liver failure grade 3. J Hepatol. 2017 Oct;67(4):708-715. doi: 10.1016/j.jhep.2017.06.009. Epub 2017 Jun 21.
Sundaram V, Jalan R, Wu T, Volk ML, Asrani SK, Klein AS, Wong RJ. Factors Associated with Survival of Patients With Severe Acute-On-Chronic Liver Failure Before and After Liver Transplantation. Gastroenterology. 2019 Apr;156(5):1381-1391.e3. doi: 10.1053/j.gastro.2018.12.007. Epub 2018 Dec 18.
Other Identifiers
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2020/01325
Identifier Type: -
Identifier Source: org_study_id
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