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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Protocol | Other | The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | survival | 1 year |
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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:
-
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Bosch | Contact | 34 93 227 1400 | anna.bosch@efclif.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Comprehensive Transplant Center | Recruiting | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25877702 | Background | 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. | |
| 28645736 |
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Samples with DNA and RNA Description: peripherical serum, plasma, urine, saliva, liver biopsy
| University of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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| Tampa General Hospital | Not yet recruiting | Tampa | Florida | 33606 | United States |
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| Piedmont Healthcare | Recruiting | Atlanta | Georgia | 30309 | United States |
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| Northwestern Memorial Hospital | Not yet recruiting | Chicago | Illinois | 60611 | United States |
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| The University of Chicago Medicine | Recruiting | Chicago | Illinois | 60637 | United States |
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| University of Maryland School of Medicine | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Weill Cornell Medicine | Recruiting | New York | New York | 10021 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029-5674 | United States |
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| Montefiore Medical Center | Not yet recruiting | New York | New York | 10467 | United States |
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| University of Cincinnati | Suspended | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| University of Pennsylvania | Suspended | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Not yet recruiting | Nashville | Tennessee | 37232 | United States |
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| Baylor College of Medicine (Scott & White) | Not yet recruiting | Dallas | Texas | 75246 | United States |
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| Michael E DeBakey VA Medical Center | Not yet recruiting | Houston | Texas | 77030-4211 | United States |
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| Baylor St. Luke's Medical Centre | Recruiting | Houston | Texas | 77030 | United States |
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| University of Utah Health | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| Austral University Hospital | Recruiting | Buenos Aires | Argentina |
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| Hospital Alemán | Recruiting | Buenos Aires | Argentina |
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| Italian Hospital in Buenos Aires | Recruiting | Buenos Aires | Argentina |
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| Austin Hospital | Recruiting | Heidelberg | Australia |
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| Sir Charles Gairdner Hospital | Suspended | Nedlands | Australia |
| Royal Prince Alfred Hospital | Recruiting | Sydney | Australia |
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| Medical University of Vienna, Department of Transplant Surgery | Recruiting | Vienna | Austria |
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| CUB Erasme Hospital | Recruiting | Brussels | Belgium |
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| Ghent University Hospital | Recruiting | Ghent | Belgium |
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| UZ Leuven | Recruiting | Leuven | Belgium |
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| Walter Cantídio University Hospital | Recruiting | Fortaleza | Brazil |
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| Irmandade Santa Casa de Misericórdia de Porto Alegre | Recruiting | Porto Alegre | Brazil |
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| Hospital das Clínicas da Universidade de São Paulo | Recruiting | São Paulo | Brazil |
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| University of Alberta | Recruiting | Edmonton | Canada |
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| University of Toronto, Multiorgan Transplant Program | Recruiting | Toronto | Canada |
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| Pablo Tobón Uribe Hospital | Recruiting | Medellín | Colombia |
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| Institute for Clinical and Experimental Medicine | Not yet recruiting | Prague | Czechia |
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| APHP Beaujon | Recruiting | Clichy | France |
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| APHP Henri Mondor | Recruiting | Créteil | France |
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| Hôpital de la Croix-Rousse | Recruiting | Lyon | France |
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| CHU Montpellier-Hôpital Saint Eloi | Recruiting | Montpellier | France |
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| APHP Hôpitaux Universitaires Pitié Salpêtrière | Recruiting | Paris | France |
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| CHU Rennes, Hôpital De Pontchaillou | Recruiting | Rennes | France |
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| Hautepièrre Hospital, Service de Réanimation Médicale | Recruiting | Strasbourg | France |
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| Trousseau Hospital, | Recruiting | Tours | France |
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| Hôpital Paul Brousse | Recruiting | Villejuif | France |
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| University Hospital Regensburg | Not yet recruiting | Regensburg | Eastern Bavaria | Germany |
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| Universitätsklinikum Schleswig-Holstein (UKSH) | Not yet recruiting | Kiel | Schleswig-Holstein | Germany |
|
| University Hospital Aachen | Suspended | Aachen | Germany |
| Charité University Hospital | Recruiting | Berlin | Germany |
|
| Goethe University Clinic | Not yet recruiting | Frankfurt | Germany |
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| University Medical Center, Hamburg Eppendorf | Recruiting | Hamburg | Germany |
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| Hannover Medical School | Not yet recruiting | Hanover | Germany |
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| University Hospital Heidelberg | Not yet recruiting | Heidelberg | Germany |
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| Jena University Hospital | Suspended | Jena | Germany |
| Universitätsklinikum Schleswig-Holstein (UKSH) | Recruiting | Kiel | Germany |
|
| Leipzig University Hospital | Not yet recruiting | Leipzig | Germany |
|
| University Hospital Mainz | Suspended | Mainz | Germany |
| LMU Großhadern | Suspended | Munich | Germany |
| UKM Muenster | Recruiting | Münster | Germany |
|
| University Hospital Tübingen | Recruiting | Tübingen | Germany |
|
| Queen Mary Hospital, The University of Hong Kong | Suspended | Hong Kong | Hong Kong |
| Aster CMI Hospital | Not yet recruiting | Bengaluru | Karnataka | India |
|
| Kasturba Hospital | Not yet recruiting | Mumbai | Maharashtra | India |
|
| Seth GSMC & KEM Hospital | Not yet recruiting | Mumbai | Maharashtra | India |
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| Indraprastha Apollo Hospitals | Not yet recruiting | New Delhi | National Capital Territory of Delhi | India |
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| Mahatma Gandhi University of Medical Sciences and Technology | Not yet recruiting | Jaipur | Rajasthan | India |
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| Dr.Rela Institute & Medical Centre | Recruiting | Chennai | India |
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| Fortis Hospital Noida, FEHI, FMRI | Not yet recruiting | Gurugramam | India |
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| Medanta Medicity | Not yet recruiting | Gurugramam | India |
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| Amrita Institute of Medical Sciences | Recruiting | Kochi | India |
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| Global Hospital. Super speciality & transplant centre | Not yet recruiting | Mumbai | India |
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| Max Saket Hospital | Active, not recruiting | New Delhi | India |
| Yashoda Hospitals | Not yet recruiting | Secunderabad | India |
|
| Ospedale Papa Giovanni XXIII- | Not yet recruiting | Bergamo | Italy |
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| S.Orsola Hospital - Alma Mater Studiorum University of Bologna | Recruiting | Bologna | Italy |
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| Ca' Granda. Policlinico Milano | Recruiting | Milan | Italy |
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| Niguarda Hospital | Recruiting | Milan | Italy |
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| University and Hospital of Padova | Recruiting | Padova | Italy |
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| Kyushu University Hospital | Recruiting | Fukuoka | Japan |
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| Hiroshima University Hospital | Recruiting | Hiroshima | Japan |
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| Kyoto University Hospital | Recruiting | Kyoto | Japan |
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| Nagasaki University Hospital | Recruiting | Nagasaki | Japan |
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| Tokyo University Hospital | Recruiting | Tokyo | Japan |
|
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Recruiting | Mexico City | Mexico |
|
| University Medical Center Groningen (UMCG) | Not yet recruiting | Groningen | Netherlands |
|
| Erasmus MC University Medical Center | Recruiting | Rotterdam | Netherlands |
|
| Auckland City Hospital- New Zealand Liver Transplant Unit | Suspended | Auckland | New Zealand |
| Medical University of Warsaw, Dept. of General, Transplant & Liver Surgery | Recruiting | Warsaw | Poland |
|
| Hospital Curry Cabral | Recruiting | Lisbon | Portugal |
|
| Samsung Medical Center | Not yet recruiting | Seoul | South Korea |
|
| Hospital Clinic in Barcelona | Recruiting | Barcelona | Spain |
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| Hospital Vall d'Hebron | Recruiting | Barcelona | Spain |
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| Hospital Universitario 12 de Octubre | Recruiting | Madrid | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Spain |
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| Hospital Marqués de Valdecilla | Recruiting | Santander | Spain |
|
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | Spain |
|
| Hospital Universitari i Politècnic La Fe | Recruiting | Valencia | Spain |
|
| Karolinska Institutet | Recruiting | Stockholm | Stockholm County | 171 77 | Sweden |
|
| Geneva University Hospital (HUG) | Not yet recruiting | Geneva | Switzerland |
|
| Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | Taiwan |
|
| Inonu University, Liver Transplantation Institute | Recruiting | Malatya | Anatolia | Turkey (Türkiye) |
|
| Istanbul Memorial Bahcelievler Hospital | Suspended | Istanbul | Turkey (Türkiye) |
| Queen Elizabeth Hospital Birmingham | Recruiting | Birmingham | United Kingdom |
|
| Scottish Liver Transplant Unit, Royal Infirmary | Recruiting | Edinburgh | United Kingdom |
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| Leeds Teaching Hospitals NHS Trust | Recruiting | Leeds | United Kingdom |
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| King's College Hospital | Recruiting | London | United Kingdom |
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| Royal Free Hospital | Recruiting | London | United Kingdom |
|
| Background |
| Artru 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. |
| 30576643 | Background | Sundaram 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. |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
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