Trials / Unknown
UnknownNCT02940600
Efficacy Evaluation of Normothermic Perfusion Machine Preservation in Liver Transplant Using Very Old Donors
Pilot, Open, Monocentric, Randomized, Prospective Trial for the Evaluation of the Efficacy of Normothermic Perfusion Machine for Organ Preservation in Liver Transplantation Using Brain Death Donors Older or Equal Than 70 Years
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Normothermic machine perfusion | Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine |
| PROCEDURE | Static cold storage | Patients undergoing liver transplant using statically cold preserved grafts |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2018-04-01
- Completion
- 2018-10-01
- First posted
- 2016-10-21
- Last updated
- 2016-10-21
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02940600. Inclusion in this directory is not an endorsement.