An interventional study of Normothermic machine perfusion and Static cold storage in Ischemic Reperfusion Injury, sponsored by Azienda Ospedaliero, Universitaria Pisana. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by Azienda Ospedaliero, Universitaria Pisana · Not applicable, Interventional, and Treatment
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
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.
271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.
This study's planned enrollment of 30 is below the median of 61 across 215 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →Azienda Ospedaliero, Universitaria Pisana is the lead sponsor of 56 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion
Device: Normothermic machine perfusion
Patients undergoing liver transplant with statically cold preserved grafts
Procedure: Static cold storage
Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine
Also known as: Liver Assist
Patients undergoing liver transplant using statically cold preserved grafts
6 months graft survival
Time frame: 180 days
Ischemia-reperfusion injury assessment through biopsies evaluation
Time frame: 1 day
ischemia reperfusion injury assessment through transaminases
AST level at post operative day number 7
Time frame: 7 days
Ischemia reperfusion injury assessment through incidence of ischemic type biliary lesions
Time frame: 180 days
Plan to share: No
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliero, Universitaria Pisana