Developing Prediction Models for Allograft Failure After Liver Transplantation (IMPROVEMENT)

• ClinicalTrials.gov Identifier: NCT05289609
• Recruitment Status: Unknown
• First Posted: March 21, 2022
• Last Update Posted: March 21, 2022
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Collaborators: University of California, Los Angeles; University Hospital Padova; Mayo Clinic; Hospital Italiano de Buenos Aires; Tokyo Women's Medical University; Hospital Universitario La Paz; First Affiliated Hospital, Sun Yat-Sen University; University of Roma La Sapienza; University of Massachusetts, Worcester; The Cleveland Clinic; Dr. Rela Institute & Medical Centre; University of Toronto; Universidade Federal do Paraná; Royal Infirmary of Edinburgh; Erasmus Medical Center
• Information provided by (Responsible Party): Prof. Alfonso Avolio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

No Study Results Posted on ClinicalTrials.gov for this Study

• Recruitment Status: Unknown
• Estimated Primary Completion Date: December 1, 2023
• Estimated Study Completion Date: April 1, 2024

Publications:

Agopian VG, Harlander-Locke MP, Markovic D, Dumronggittigule W, Xia V, Kaldas FM, Zarrinpar A, Yersiz H, Farmer DG, Hiatt JR, Busuttil RW. Evaluation of Early Allograft Function Using the Liver Graft Assessment Following Transplantation Risk Score Model. JAMA Surg. 2018 May 1;153(5):436-444. doi: 10.1001/jamasurg.2017.5040. Erratum In: JAMA Surg. 2018 May 1;153(5):498.

Agopian VG, Markovic D, Klintmalm GB, Saracino G, Chapman WC, Vachharajani N, Florman SS, Tabrizian P, Haydel B, Nasralla D, Friend PJ, Boteon YL, Ploeg R, Harlander-Locke MP, Xia V, DiNorcia J, Kaldas FM, Yersiz H, Farmer DG, Busuttil RW. Multicenter validation of the liver graft assessment following transplantation (L-GrAFT) score for assessment of early allograft dysfunction. J Hepatol. 2021 Apr;74(4):881-892. doi: 10.1016/j.jhep.2020.09.015. Epub 2020 Sep 23.

Avolio AW, Franco A, Schlegel A, Lai Q, Meli S, Burra P, Patrono D, Ravaioli M, Bassi D, Ferla F, Pagano D, Violi P, Camagni S, Dondossola D, Montalti R, Alrawashdeh W, Vitale A, Teofili L, Spoletini G, Magistri P, Bongini M, Rossi M, Mazzaferro V, Di Benedetto F, Hammond J, Vivarelli M, Agnes S, Colledan M, Carraro A, Cescon M, De Carlis L, Caccamo L, Gruttadauria S, Muiesan P, Cillo U, Romagnoli R, De Simone P. Development and Validation of a Comprehensive Model to Estimate Early Allograft Failure Among Patients Requiring Early Liver Retransplant. JAMA Surg. 2020 Dec 1;155(12):e204095. doi: 10.1001/jamasurg.2020.4095. Epub 2020 Dec 16. Erratum In: JAMA Surg. 2021 Jan 1;156(1):105.

Avolio AW, Lai Q, Cillo U, Romagnoli R, De Simone P. L-GrAFT and EASE scores in liver transplantation: Need for reciprocal external validation and comparison with other scores. J Hepatol. 2021 Sep;75(3):729-731. doi: 10.1016/j.jhep.2020.12.009. Epub 2020 Dec 17. No abstract available.

Avolio AW, Contegiacomo A, Spoletini G, Moschetta G, Bianco G, Agnes S, Melcher ML, Burra P. Toward a novel evidence-based definition of early allograft failure in the perspective of liver retransplant. Transpl Int. 2021 Dec;34(12):2905-2907. doi: 10.1111/tri.14162. Epub 2021 Dec 6. No abstract available.

Croome KP, Mathur AK, Aqel B, Yang L, Taner T, Heimbach JK, Rosen CB, Paz-Fumagalli R, Taner CB. Classification of Distinct Patterns of Ischemic Cholangiopathy Following DCD Liver Transplantation: Distinct Clinical Courses and Long-term Outcomes From a Multicenter Cohort. Transplantation. 2022 Jun 1;106(6):1206-1214. doi: 10.1097/TP.0000000000003928. Epub 2022 Aug 30.

Chen S, Wang T, Luo T, He S, Huang C, Jia Z, Zhan L, Wang D, Zhu X, Guo Z, He X. Prediction of Graft Survival Post-liver Transplantation by L-GrAFT Risk Score Model, EASE Score, MEAF Scoring, and EAD. Front Surg. 2021 Nov 19;8:753056. doi: 10.3389/fsurg.2021.753056. eCollection 2021.

Lai Q, Magistri P, Lionetti R, Avolio AW, Lenci I, Giannelli V, Pecchi A, Ferri F, Marrone G, Angelico M, Milana M, Schinnina V, Menozzi R, Di Martino M, Grieco A, Manzia TM, Tisone G, Agnes S, Rossi M, Di Benedetto F, Ettorre GM; Sarco-Model Study Group. Sarco-Model: A score to predict the dropout risk in the perspective of organ allocation in patients awaiting liver transplantation. Liver Int. 2021 Jul;41(7):1629-1640. doi: 10.1111/liv.14889. Epub 2021 Apr 22.

Martins PN, Rizzari MD, Ghinolfi D, Jochmans I, Attia M, Jalan R, Friend PJ; ILTS Special Interest Group "DCD, Preservation and Machine Perfusion". Design, Analysis, and Pitfalls of Clinical Trials Using Ex Situ Liver Machine Perfusion: The International Liver Transplantation Society Consensus Guidelines. Transplantation. 2021 Apr 1;105(4):796-815. doi: 10.1097/TP.0000000000003573.

Pareja E, Cortes M, Hervas D, Mir J, Valdivieso A, Castell JV, Lahoz A. A score model for the continuous grading of early allograft dysfunction severity. Liver Transpl. 2015 Jan;21(1):38-46. doi: 10.1002/lt.23990. Epub 2014 Nov 24.

Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.

Patrono D, Cussa D, Sciannameo V, Montanari E, Panconesi R, Berchialla P, Lepore M, Gambella A, Rizza G, Catalano G, Mirabella S, Tandoi F, Lupo F, Balagna R, Salizzoni M, Romagnoli R. Outcome of liver transplantation with grafts from brain-dead donors treated with dual hypothermic oxygenated machine perfusion, with particular reference to elderly donors. Am J Transplant. 2022 May;22(5):1382-1395. doi: 10.1111/ajt.16996. Epub 2022 Feb 22.

Petrowsky H, Rana A, Kaldas FM, Sharma A, Hong JC, Agopian VG, Durazo F, Honda H, Gornbein J, Wu V, Farmer DG, Hiatt JR, Busuttil RW. Liver transplantation in highest acuity recipients: identifying factors to avoid futility. Ann Surg. 2014 Jun;259(6):1186-94. doi: 10.1097/SLA.0000000000000265.

Schlegel A, van Reeven M, Croome K, Parente A, Dolcet A, Widmer J, Meurisse N, De Carlis R, Hessheimer A, Jochmans I, Mueller M, van Leeuwen OB, Nair A, Tomiyama K, Sherif A, Elsharif M, Kron P, van der Helm D, Borja-Cacho D, Bohorquez H, Germanova D, Dondossola D, Olivieri T, Camagni S, Gorgen A, Patrono D, Cescon M, Croome S, Panconesi R, Carvalho MF, Ravaioli M, Caicedo JC, Loss G, Lucidi V, Sapisochin G, Romagnoli R, Jassem W, Colledan M, De Carlis L, Rossi G, Di Benedetto F, Miller CM, van Hoek B, Attia M, Lodge P, Hernandez-Alejandro R, Detry O, Quintini C, Oniscu GC, Fondevila C, Malago M, Pirenne J, IJzermans JNM, Porte RJ, Dutkowski P, Taner CB, Heaton N, Clavien PA, Polak WG, Muiesan P; DCD Collaborator Group. A multicentre outcome analysis to define global benchmarks for donation after circulatory death liver transplantation. J Hepatol. 2022 Feb;76(2):371-382. doi: 10.1016/j.jhep.2021.10.004. Epub 2021 Oct 14.

Spoletini G, Ferri F, Mauro A, Mennini G, Bianco G, Cardinale V, Agnes S, Rossi M, Avolio AW, Lai Q. CONUT Score Predicts Early Morbidity After Liver Transplantation: A Collaborative Study. Front Nutr. 2022 Jan 7;8:793885. doi: 10.3389/fnut.2021.793885. eCollection 2021.

Aby ES, Lee E, Saggi SS, Viramontes MR, Grotts JF, Agopian VG, Busuttil RW, Saab S. Pretransplant Sarcopenia in Patients With NASH Cirrhosis Does Not Impact Rehospitalization or Mortality. J Clin Gastroenterol. 2019 Oct;53(9):680-685. doi: 10.1097/MCG.0000000000001109.