Document Type
Article
Publication Date
12-27-2018
Abstract
BACKGROUND: Liver transplantation is the best treatment for end-stage liver disease. The interruption of the blood supply to the donor liver during cold storage damages the liver, affecting how well the liver will function after transplant. The drug Simvastatin may help to protect donor livers against this damage and improve outcomes for transplant recipients. The aim of this study is to evaluate the benefits of treating the donor liver with Simvastatin compared with the standard transplant procedure.
PATIENT AND METHODS: We propose a prospective, double-blinded, randomized phase 2 study of 2 parallel groups of eligible adult patients. We will compare 3-month, 6-month, and 12-month graft survival after LT, in order to identify a significant relation between the two homogenous groups of LT patients. The two groups only differ by the Simvastatin or placebo administration regimen while following the same procedure, with identical surgical instruments, and medical and nursing skilled staff. To reach these goals, we determined that we needed to recruit 106 patients. This sample size achieves 90% power to detect a difference of 14.6% between the two groups survival using a one-sided binomial test.
DISCUSSION: This trial is designed to confirm the effectiveness of Simvastatin to protect healthy and steatotic livers undergoing cold storage and warm reperfusion before transplantation and to evaluate if the addition of Simvastatin translates into improved graft outcomes.
TRIAL REGISTRATION: ISRCTN27083228 .
Recommended Citation
Pagano, Duilio; Oliva, Elisabetta; Khouzam, Simone; Tuzzolino, Fabio; Cintorino, Davide; Li Petri, Sergio; di Francesco, Fabrizio; Ricotta, Calogero; Bonsignore, Pasquale; Tropea, Alessandro; Calamia, Sergio; Costanzo, Federico; Luca, Angelo; and Gruttadauria, Salvatore, "The addition of simvastatin administration to cold storage solution of explanted whole liver grafts for facing ischemia/reperfusion injury in an area with a low rate of deceased donation: a monocentric randomized controlled double-blinded phase 2 study." (2018). Student Papers, Posters & Projects. Paper 23.
https://jdc.jefferson.edu/student_papers/23
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
Language
English
Comments
This article has been peer reviewed. It is the author’s final published version in BMC Surgery, Volume 18, Issue 1, December 2018, Article number 122.
The published version is available at https://doi.org/10.1186/s12893-018-0455-7. Copyright © Pagano et al.