Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs
- Conditions
- Liver Transplant; ComplicationsLiver DiseasesLiver CirrhosisAcute-On-Chronic Liver Failure
- Interventions
- Other: Observational Protocol
- Registration Number
- NCT04613921
- Lead Sponsor
- European Foundation for Study of Chronic Liver Failure
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
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Male or female subject ≥18 years of age.
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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.
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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.
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Group 3: patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Observational Protocol 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 Observational Protocol 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 Observational Protocol patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation (n=500)
- Primary Outcome Measures
Name Time Method Survival 1 year survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (105)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
Michael E DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Hospital Alemán
🇦🇷Buenos Aires, Argentina
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine (Scott & White)
🇺🇸Dallas, Texas, United States
Cedars-Sinai Comprehensive Transplant Center
🇺🇸Los Angeles, California, United States
The University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Irmandade Santa Casa de Misericórdia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Hospital das Clínicas da Universidade de São Paulo
🇧🇷São Paulo, Brazil
University of Toronto, Multiorgan Transplant Program
🇨🇦Toronto, Canada
CHU Montpellier-Hôpital Saint Eloi
🇫🇷Montpellier, France
CHU Rennes, Hôpital De Pontchaillou
🇫🇷Rennes, France
Trousseau Hospital,
🇫🇷Tours, France
University Hospital Regensburg
🇩🇪Regensburg, Eastern Bavaria, Germany
University Hospital Aachen
🇩🇪Aachen, Germany
Goethe University Clinic
🇩🇪Frankfurt, Germany
Leipzig University Hospital
🇩🇪Leipzig, Germany
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Pablo Tobón Uribe Hospital
🇨🇴Medellín, Colombia
APHP Henri Mondor
🇫🇷Créteil, France
Hautepièrre Hospital, Service de Réanimation Médicale
🇫🇷Strasbourg, France
Universitätsklinikum Schleswig-Holstein (UKSH)
🇩🇪Kiel, Germany
University Hospital Mainz
🇩🇪Mainz, Germany
Global Hospital. Super speciality & transplant centre
🇮🇳Mumbai, India
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Seth GSMC & KEM Hospital
🇮🇳Mumbai, Maharashtra, India
Austral University Hospital
🇦🇷Buenos Aires, Argentina
Austin Hospital
🇦🇺Heidelberg, Australia
Royal Prince Alfred Hospital
🇦🇺Sydney, Australia
Walter Cantídio University Hospital
🇧🇷Fortaleza, Brazil
Baylor St. Luke's Medical Centre
🇺🇸Houston, Texas, United States
APHP Beaujon
🇫🇷Clichy, France
University Hospital Heidelberg
🇩🇪Heidelberg, Germany
Jena University Hospital
🇩🇪Jena, Germany
University Hospital Tübingen
🇩🇪Tübingen, Germany
Max Saket Hospital
🇮🇳New Delhi, India
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Australia
CUB Erasme Hospital
🇧🇪Brussels, Belgium
Ghent University Hospital
🇧🇪Ghent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Hannover Medical School
🇩🇪Hannover, Germany
LMU Großhadern
🇩🇪Munich, Germany
Fortis Hospital Noida, FEHI, FMRI
🇮🇳Gurugramam, India
Medanta Medicity
🇮🇳Gurugramam, India
S.Orsola Hospital - Alma Mater Studiorum University of Bologna
🇮🇹Bologna, Italy
APHP Hôpitaux Universitaires Pitié Salpêtrière
🇫🇷Paris, France
Aster CMI Hospital
🇮🇳Bengaluru, Karnataka, India
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Italian Hospital in Buenos Aires
🇦🇷Buenos Aires, Argentina
Medical University of Vienna, Department of Transplant Surgery
🇦🇹Wien, Austria
University of Alberta
🇨🇦Edmonton, Canada
Hôpital Paul Brousse
🇫🇷Villejuif, France
UKM Muenster
🇩🇪Münster, Germany
Queen Mary Hospital, The University of Hong Kong
🇭🇰Hong Kong, Hong Kong
Dr.Rela Institute & Medical Centre
🇮🇳Chennai, India
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Charité University Hospital
🇩🇪Berlin, Germany
University Medical Center, Hamburg Eppendorf
🇩🇪Hamburg, Germany
Mahatma Gandhi University of Medical Sciences and Technology
🇮🇳Jaipur, Rajasthan, India
Hôpital de la Croix-Rousse
🇫🇷Lyon, France
Amrita Institute of Medical Sciences
🇮🇳Kochi, India
Ospedale Papa Giovanni XXIII-
🇮🇹Bergamo, Italy
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
🇲🇽Mexico City, Mexico
Indraprastha Apollo Hospitals
🇮🇳New Delhi, Delhi, India
Yashoda Hospitals
🇮🇳Secunderabad, India
Ca' Granda. Policlinico Milano
🇮🇹Milan, Italy
Erasmus MC University Medical Center
🇳🇱Rotterdam, Netherlands
Hospital Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Clinic in Barcelona
🇪🇸Barcelona, Spain
Niguarda Hospital
🇮🇹Milan, Italy
University and Hospital of Padova
🇮🇹Padova, Italy
Royal Free Hospital
🇬🇧London, United Kingdom
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
University Medical Center Groningen (UMCG)
🇳🇱Groningen, Netherlands
Hospital Curry Cabral
🇵🇹Lisboa, Portugal
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Karolinska Institutet
🇸🇪Stockholm, Sweden
Geneva University Hospital (HUG)
🇨🇭Geneva, Switzerland
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Scottish Liver Transplant Unit, Royal Infirmary
🇬🇧Edinburgh, United Kingdom
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Kyoto University Hospital
🇯🇵Kyoto, Japan
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Tokyo University Hospital
🇯🇵Tokyo, Japan
Auckland City Hospital- New Zealand Liver Transplant Unit
🇳🇿Auckland, New Zealand
Medical University of Warsaw, Dept. of General, Transplant & Liver Surgery
🇵🇱Warsaw, Poland
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Queen Elizabeth Hospital Birmingham
🇬🇧Birmingham, United Kingdom
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Inonu University, Liver Transplantation Institute
🇹🇷Malatya, Anatolia, Turkey
King's College Hospital
🇬🇧London, United Kingdom
Istanbul Memorial Bahcelievler Hospital
🇹🇷Istanbul, Turkey
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
University of Colorado
🇺🇸Aurora, Colorado, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Institute for Clinical and Experimental Medicine
🇨🇿Praha, Czechia
Kasturba Hospital
🇮🇳Mumbai, Maharashtra, India
Montefiore Medical Center
🇺🇸New York, New York, United States