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

Status: Recruiting
Location: See all (105) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
View:

• 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

Locations
United States
California
Cedars-Sinai Comprehensive Transplant Center
RECRUITING
Los Angeles
Colorado
University of Colorado
RECRUITING
Aurora
Florida
Tampa General Hospital
NOT_YET_RECRUITING
Tampa
Georgia
Piedmont Healthcare
RECRUITING
Atlanta
Illinois
Northwestern Memorial Hospital
NOT_YET_RECRUITING
Chicago
The University of Chicago Medicine
RECRUITING
Chicago
Maryland
University of Maryland School of Medicine
RECRUITING
Baltimore
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Montefiore Medical Center
NOT_YET_RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Ohio
University of Cincinnati
SUSPENDED
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania
SUSPENDED
Philadelphia
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
Baylor College of Medicine (Scott & White)
NOT_YET_RECRUITING
Dallas
Baylor St. Luke's Medical Centre
RECRUITING
Houston
Michael E DeBakey VA Medical Center
NOT_YET_RECRUITING
Houston
Utah
University of Utah Health
RECRUITING
Salt Lake City
Other Locations
Argentina
Austral University Hospital
RECRUITING
Buenos Aires
Hospital Alemán
RECRUITING
Buenos Aires
Italian Hospital in Buenos Aires
RECRUITING
Buenos Aires
Australia
Austin Hospital
RECRUITING
Heidelberg
Sir Charles Gairdner Hospital
SUSPENDED
Nedlands
Royal Prince Alfred Hospital
RECRUITING
Sydney
Austria
Medical University of Vienna, Department of Transplant Surgery
RECRUITING
Vienna
Belgium
CUB Erasme Hospital
RECRUITING
Brussels
Ghent University Hospital
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Brazil
Walter Cantídio University Hospital
RECRUITING
Fortaleza
Irmandade Santa Casa de Misericórdia de Porto Alegre
RECRUITING
Porto Alegre
Hospital das Clínicas da Universidade de São Paulo
RECRUITING
São Paulo
Canada
University of Alberta
RECRUITING
Edmonton
University of Toronto, Multiorgan Transplant Program
RECRUITING
Toronto
Colombia
Pablo Tobón Uribe Hospital
RECRUITING
Medellín
France
APHP Beaujon
RECRUITING
Clichy
APHP Henri Mondor
RECRUITING
Créteil
Hôpital de la Croix-Rousse
RECRUITING
Lyon
CHU Montpellier-Hôpital Saint Eloi
RECRUITING
Montpellier
APHP Hôpitaux Universitaires Pitié Salpêtrière
RECRUITING
Paris
CHU Rennes, Hôpital De Pontchaillou
RECRUITING
Rennes
Hautepièrre Hospital, Service de Réanimation Médicale
RECRUITING
Strasbourg
Trousseau Hospital,
RECRUITING
Tours
Hôpital Paul Brousse
RECRUITING
Villejuif
Germany
University Hospital Aachen
SUSPENDED
Aachen
Charité University Hospital
RECRUITING
Berlin
Goethe University Clinic
NOT_YET_RECRUITING
Frankfurt
University Medical Center, Hamburg Eppendorf
RECRUITING
Hamburg
Hannover Medical School
NOT_YET_RECRUITING
Hanover
University Hospital Heidelberg
NOT_YET_RECRUITING
Heidelberg
Jena University Hospital
SUSPENDED
Jena
Universitätsklinikum Schleswig-Holstein (UKSH)
RECRUITING
Kiel
Universitätsklinikum Schleswig-Holstein (UKSH)
NOT_YET_RECRUITING
Kiel
Leipzig University Hospital
NOT_YET_RECRUITING
Leipzig
University Hospital Mainz
SUSPENDED
Mainz
LMU Großhadern
SUSPENDED
Munich
UKM Muenster
RECRUITING
Münster
University Hospital Regensburg
NOT_YET_RECRUITING
Regensburg
University Hospital Tübingen
RECRUITING
Tübingen
Hong Kong Special Administrative Region
Queen Mary Hospital, The University of Hong Kong
SUSPENDED
Hong Kong
India
Aster CMI Hospital
NOT_YET_RECRUITING
Bengaluru
Dr.Rela Institute & Medical Centre
RECRUITING
Chennai
Fortis Hospital Noida, FEHI, FMRI
NOT_YET_RECRUITING
Gurugramam
Medanta Medicity
NOT_YET_RECRUITING
Gurugramam
Mahatma Gandhi University of Medical Sciences and Technology
NOT_YET_RECRUITING
Jaipur
Amrita Institute of Medical Sciences
RECRUITING
Kochi
Global Hospital. Super speciality & transplant centre
NOT_YET_RECRUITING
Mumbai
Kasturba Hospital
NOT_YET_RECRUITING
Mumbai
Seth GSMC & KEM Hospital
NOT_YET_RECRUITING
Mumbai
Indraprastha Apollo Hospitals
NOT_YET_RECRUITING
New Delhi
Max Saket Hospital
ACTIVE_NOT_RECRUITING
New Delhi
Yashoda Hospitals
NOT_YET_RECRUITING
Secunderabad
Italy
Ospedale Papa Giovanni XXIII-
NOT_YET_RECRUITING
Bergamo
S.Orsola Hospital - Alma Mater Studiorum University of Bologna
RECRUITING
Bologna
Ca' Granda. Policlinico Milano
RECRUITING
Milan
Niguarda Hospital
RECRUITING
Milan
University and Hospital of Padova
RECRUITING
Padua
Japan
Kyushu University Hospital
RECRUITING
Fukuoka
Hiroshima University Hospital
RECRUITING
Hiroshima
Kyoto University Hospital
RECRUITING
Kyoto
Nagasaki University Hospital
RECRUITING
Nagasaki
Tokyo University Hospital
RECRUITING
Tokyo
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
RECRUITING
Mexico City
Netherlands
University Medical Center Groningen (UMCG)
NOT_YET_RECRUITING
Groningen
Erasmus MC University Medical Center
RECRUITING
Rotterdam
New Zealand
Auckland City Hospital- New Zealand Liver Transplant Unit
SUSPENDED
Auckland
Poland
Medical University of Warsaw, Dept. of General, Transplant & Liver Surgery
RECRUITING
Warsaw
Portugal
Hospital Curry Cabral
RECRUITING
Lisbon
Republic of Korea
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Spain
Hospital Clinic in Barcelona
RECRUITING
Barcelona
Hospital Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Universitari i Politècnic La Fe
RECRUITING
Valencia
Sweden
Karolinska Institutet
RECRUITING
Stockholm
Switzerland
Geneva University Hospital (HUG)
NOT_YET_RECRUITING
Geneva
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Turkey
Istanbul Memorial Bahcelievler Hospital
SUSPENDED
Istanbul
Inonu University, Liver Transplantation Institute
RECRUITING
Malatya
United Kingdom
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Scottish Liver Transplant Unit, Royal Infirmary
RECRUITING
Edinburgh
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
King's College Hospital
RECRUITING
London
Royal Free Hospital
RECRUITING
London
Contact Information
Primary
Anna Bosch
anna.bosch@efclif.com
34 93 227 1400
Time Frame
Start Date: 2021-07-08
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 3000
Treatments
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)
Authors
Tasneem Pirelli, Kamil Polat
Sponsors
Leads: European Foundation for Study of Chronic Liver Failure

This content was sourced from clinicaltrials.gov

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