Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs
CHANCE
1 other identifier
observational
3,000
26 countries
103
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Longer than P75 for all trials
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedStudy Start
First participant enrolled
July 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 20, 2025
October 1, 2025
5.5 years
October 28, 2020
October 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Survival
survival
1 year
Study Arms (3)
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
The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)
Eligibility Criteria
Acute or subacute liver failure. Patients with hepatocellular carcinoma Subjects listed for transplantation other than liver or liver-kidney transplant. Subjects with previous liver transplantation. Vulnerable population. Pregnant and/or breastfeeding woman Patients with relevant comorbidities
You may qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
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
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, 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
Related Publications (3)
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.
PMID: 25877702BACKGROUNDArtru 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.
PMID: 28645736BACKGROUNDSundaram 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.
PMID: 30576643BACKGROUND
Biospecimen
Samples with DNA and RNA Description: peripherical serum, plasma, urine, saliva, liver biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
November 3, 2020
Study Start
July 8, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share