PI, Alfonso W. Avolio, MD, General Surgery and Liver Transplant Unit, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Catholic University of Rome, L.go A.Gemelli, 8, Rome Italy – 00168.
Co-PI, Vatche G. Agopian, MD, Liver Cancer Center – General Surgery and Liver Transplant Unit, David Geffen School of Medicine at University of California Los Angeles, 10833 Le Conte Ave, Los Angeles, CA 90095.
Vatche Agopian (US), firstname.lastname@example.org
Alfonso Avolio (IT), email@example.com
Patrizia Burra (IT), firstname.lastname@example.org
Umberto Cillo (IT), email@example.com
Kris Croome (US), firstname.lastname@example.org
Martin De Santibanes (Argentina), email@example.com
Hiroto Egawa (Japan), firstname.lastname@example.org
Constantino Fondevila (Spain), email@example.com
Zhiyong Guo (China), firstname.lastname@example.org
Quirino Lai (IT), email@example.com
Paulo Martins (US), firstname.lastname@example.org
Gabriel Oniscu (UK), email@example.com
Wojtek Polak (NE), firstname.lastname@example.org
Cristiano Quintini (US), email@example.com
Mohamed Rela (India), firstname.lastname@example.org
Gonzalo Sapisochin (Canada), email@example.com
Julio Wielderkehr (Brazil), firstname.lastname@example.org
Data Collection & Management
The IMPROVEMENT study is an observational and non-competitive study aimed to validate and optimize prediction kinetic models of 90-day and 1-year allograft failure after liver transplantation.
It includes a prospective cohort, reserved for high-volume Centers (>65 transplants per year), and a retrospective one reserved for intermediate and low-volume Centers (<65 transplants per year). High-volume Centers may participate in prospective and retrospective enrollment.
Standard Deceased Donors grafts, Extended Criteria grafts, Cardiac Death Donor grafts, and Living Donor grafts will be included according to the practice of Centers. Each Center is invited to enroll a fixed number of consecutive grafts (50 for the prospective cohort and 75 for the retrospective cohort). Notably, the histological assessment of graft steatosis obtained after graft reperfusion is desirable (prospective cohort). Furthermore, patients will be prospectively evaluated by frailty, nutritional, and sarcopenia assessments to disentangle the indication/contraindication to re-transplant. The degree of cardiac dysfunction, renal failure, respiratory failure, abdominal and lung infection, sepsis, and septic shock will be also investigated as well as technical issues potentially leading to allograft failure.
In this repository, the study protocol with annexes, the approval by the Ethics Committee of the promoting Center, a set of slides, the FAQs and the articles inherent to the study are available for download.
DOCUMENTS READY FOR DOWNLOAD:
INSTRUCTION FOR DATA COLLECTION:
SPECIFIC FILES FOR INSTITUTIONAL REVIEW BOARDS:
1. Ethics_Committee_Approval_(1st round ver 2.0)_PLUS_The_IMPROVEMENT_ver_2.0_031221
2. English_Language_TO_WHOM_IT_MAY_CONCERN_Approval_ver_2.0_THE IMPROVEMENT Study
5. Ethics_Committee_Approval-(2nd round – only_approval ver 2.1) – The_IMPROVEMENT_Study_270122
7. Consent_form_for_patients (ITALIAN LANGUAGE – ver_2.1_23_dicembre_2021