Ischemic Reperfusion Injury
Conditions
Keywords
normothermic perfusion, old donors, extended criteria grafts, reconditioning
Brief summary
The purpose of this study is to evaluate the impact of normothermic machine perfusion in liver transplantation using grafts of brain death donors older or equal than 70 years
Detailed description
Mean donor age for liver transplantation in Tuscany, Italy, is increasing and is actually 71 years. Old donors are a valuable resource but their use has been related to a major incidence of primary non function (PNF), delayed graft function (DGF) and ischemic type biliary lesions (ITBL). Ischemia-reperfusion injury is a major reason for the development of these complications and and old grafts are more susceptible than younger ones. Normothermic machine perfusion (NMP) is a novel and promising technique that allows preservation in a more physiological environment. It is our belief that the use of NMP might reduce the impact of ischemia-reperfusion injuries in older grafts thus reducing the incidence of complications and providing a better outcome.
Interventions
Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine
PROCEDUREStatic cold storage
Patients undergoing liver transplant using statically cold preserved grafts
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient on waiting list for liver transplant * Signed informed consent * Age between 18 and 70 * Eligibility for liver transplant as for University of Pisa Liver Transplant Center Protocol * Capacity and willingness to participate to the protocol
Exclusion criteria
* No signed informed consent * Age under 18 or over 70 * Presence of disease that may influence results * Patient participation to other studies * Re-liver transplant * ABO incompatible OLT * Multiorgan transplant * Liver transplant for acute liver failure or trauma * MELD (model for end stage liver disease) \>24 * Patient not suitable to participate on investigators's opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 months graft survival | 180 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ischemia-reperfusion injury assessment through biopsies evaluation | 1 day | — |
| ischemia reperfusion injury assessment through transaminases | 7 days | AST level at post operative day number 7 |
| Ischemia reperfusion injury assessment through incidence of ischemic type biliary lesions | 180 days | — |
Countries
Italy
Contacts
Primary ContactDavide Ghinolfi, MD, PhD
Backup ContactDaniele Pezzati, MD
Outcome results
None listed