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Recruiting NCT04613921

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

Conditions: Liver Diseases Liver Cirrhosis Acute-On-Chronic Liver Failure Liver Transplant; Complications

Sponsor: European Foundation for Study of Chronic Liver Failure

trial.available_in: БГ
Overview
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.
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.
Who can participate
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: \-
Locations 24
Argentina (1)
Austral University Hospital
Buenos Aires
Australia (1)
Austin Hospital
Heidelberg
Belgium (1)
CUB Erasme Hospital
Brussels
Brazil (1)
Walter Cantídio University Hospital
Fortaleza
Canada (1)
University of Alberta
Edmonton
Dean Karvellas
Colombia (1)
Pablo Tobón Uribe Hospital
Medellín
Czech Republic (1)
Institute for Clinical and Experimental Medicine
Prague
NOT_YET_RECRUITING
Eva Kieslichová
France (1)
APHP Beaujon
Clichy
Germany (1)
University Hospital Regensburg
Regensburg , Eastern Bavaria
NOT_YET_RECRUITING
Martina Müller-Schilling, MD
Hong Kong (1)
Queen Mary Hospital, The University of Hong Kong
Hong Kong
SUSPENDED
India (1)
Aster CMI Hospital
Bengaluru , Karnataka
NOT_YET_RECRUITING
Italy (1)
Ospedale Papa Giovanni XXIII-
Bergamo
NOT_YET_RECRUITING
Stefano Fagiouli
Japan (1)
Kyushu University Hospital
Fukuoka
Mexico (1)
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City
Netherlands (1)
University Medical Center Groningen (UMCG)
Groningen
NOT_YET_RECRUITING
New Zealand (1)
Auckland City Hospital- New Zealand Liver Transplant Unit
Auckland
SUSPENDED
Poland (1)
Medical University of Warsaw, Dept. of General, Transplant & Liver Surgery
Warsaw
South Korea (1)
Samsung Medical Center
Seoul
NOT_YET_RECRUITING
Spain (1)
Hospital Clinic in Barcelona
Barcelona
Sweden (1)
Karolinska Institutet
Stockholm , Stockholm County
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Chee Chien Yong
Turkey (1)
Inonu University, Liver Transplantation Institute
Malatya , Anatolia
Sezai Yilmaz, Prof
United Kingdom (1)
Queen Elizabeth Hospital Birmingham
Birmingham
United States (1)
Cedars-Sinai Comprehensive Transplant Center
Los Angeles , California
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
08.07.2021
Completion date
31.12.2026
Registry ID
NCT04613921
Source
anzctr
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