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

NCT04613921 · tracked via the Priya Life Science Germany tracker

Sponsor

European Foundation for Study of Chronic Liver Failure

Phase

Observational

Started

2021-07-08

Last updated

2025-10-20

Condition(s) studied

Liver DiseasesLiver CirrhosisAcute-On-Chronic Liver FailureLiver Transplant; Complications

Investigational drug(s) / intervention(s)

Observational Protocol

Observational Protocol: The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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: \-

Primary outcome measure(s)

Survival — 1 year
survival

Trial sites (106)

Facility	City	Region	Status
Cedars-Sinai Comprehensive Transplant Center	Los Angeles	California	Recruiting
University of Colorado	Aurora	Colorado	Recruiting
Tampa General Hospital	Tampa	Florida	Not Yet Recruiting
Piedmont Healthcare	Atlanta	Georgia	Recruiting
Northwestern Memorial Hospital	Chicago	Illinois	Not Yet Recruiting
The University of Chicago Medicine	Chicago	Illinois	Recruiting
University of Maryland School of Medicine	Baltimore	Maryland	Recruiting
Weill Cornell Medicine	New York	New York	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	Recruiting
Montefiore Medical Center	New York	New York	Not Yet Recruiting
University of Cincinnati	Cincinnati	Ohio	Suspended
Cleveland Clinic	Cleveland	Ohio	Recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	Suspended
Vanderbilt University Medical Center	Nashville	Tennessee	Not Yet Recruiting
Baylor College of Medicine (Scott & White)	Dallas	Texas	Not Yet Recruiting
Michael E DeBakey VA Medical Center	Houston	Texas	Not Yet Recruiting
Baylor St. Luke's Medical Centre	Houston	Texas	Recruiting
University of Utah Health	Salt Lake City	Utah	Recruiting
Austral University Hospital	Buenos Aires	Argentina	Recruiting
Hospital Alemán	Buenos Aires	Argentina	Recruiting
Italian Hospital in Buenos Aires	Buenos Aires	Argentina	Recruiting
Austin Hospital	Heidelberg	Australia	Recruiting
Sir Charles Gairdner Hospital	Nedlands	Australia	Suspended
Royal Prince Alfred Hospital	Sydney	Australia	Recruiting
Medical University of Vienna, Department of Transplant Surgery	Vienna	Austria	Recruiting
CUB Erasme Hospital	Brussels	Belgium	Recruiting
Ghent University Hospital	Ghent	Belgium	Recruiting
UZ Leuven	Leuven	Belgium	Recruiting
Walter Cantídio University Hospital	Fortaleza	Brazil	Recruiting
Irmandade Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Brazil	Recruiting
Hospital das Clínicas da Universidade de São Paulo	São Paulo	Brazil	Recruiting
University of Alberta	Edmonton	Canada	Recruiting
University of Toronto, Multiorgan Transplant Program	Toronto	Canada	Recruiting
Pablo Tobón Uribe Hospital	Medellín	Colombia	Recruiting
Institute for Clinical and Experimental Medicine	Prague	Czechia	Not Yet Recruiting
APHP Beaujon	Clichy	France	Recruiting
APHP Henri Mondor	Créteil	France	Recruiting
Hôpital de la Croix-Rousse	Lyon	France	Recruiting
CHU Montpellier-Hôpital Saint Eloi	Montpellier	France	Recruiting
APHP Hôpitaux Universitaires Pitié Salpêtrière	Paris	France	Recruiting

+ 66 more sites — see the full list on the official registry below.

More European Foundation for Study of Chronic Liver Failure trials in Germany

A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial). Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04613921 on ClinicalTrials.gov ↗ ← All trials in Germany