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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normothermic machine perfusion | Experimental | Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion |
|
| Static cold storage | Active Comparator | Patients undergoing liver transplant with statically cold preserved grafts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normothermic machine perfusion | Device | Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 months graft survival | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemia-reperfusion injury assessment through biopsies evaluation | 1 day | |
| ischemia reperfusion injury assessment through transaminases | AST level at post operative day number 7 | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Davide Ghinolfi, MD, PhD | Contact | +39050995421 | d.ghinolfi@ao-pisa.toscana.it | |
| Daniele Pezzati, MD | Contact | +393202172957 | danypez@hotmail.it |
| Name | Affiliation | Role |
|---|---|---|
| Davide Ghinolfi, MD, PhD | Azienda Ospedaliero, Universitaria Pisana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UO Chirurgia Epatica e del Trapianto di Fegato | Recruiting | Pisa | Pisa | 56124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27639262 | Background | Bral M, Gala-Lopez B, Bigam D, Kneteman N, Malcolm A, Livingstone S, Andres A, Emamaullee J, Russell L, Coussios C, West LJ, Friend PJ, Shapiro AM. Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial. Am J Transplant. 2017 Apr;17(4):1071-1080. doi: 10.1111/ajt.14049. Epub 2016 Dec 9. | |
| 27192971 |
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|
| Static cold storage | Procedure | Patients undergoing liver transplant using statically cold preserved grafts |
|
| Ischemia reperfusion injury assessment through incidence of ischemic type biliary lesions | 180 days |
| Mergental H, Perera MT, Laing RW, Muiesan P, Isaac JR, Smith A, Stephenson BT, Cilliers H, Neil DA, Hubscher SG, Afford SC, Mirza DF. Transplantation of Declined Liver Allografts Following Normothermic Ex-Situ Evaluation. Am J Transplant. 2016 Nov;16(11):3235-3245. doi: 10.1111/ajt.13875. Epub 2016 Jul 13. |
| 26946466 | Background | Op den Dries S, Karimian N, Westerkamp AC, Sutton ME, Kuipers M, Wiersema-Buist J, Ottens PJ, Kuipers J, Giepmans BN, Leuvenink HG, Lisman T, Porte RJ. Normothermic machine perfusion reduces bile duct injury and improves biliary epithelial function in rat donor livers. Liver Transpl. 2016 Jul;22(7):994-1005. doi: 10.1002/lt.24436. |
| 26752191 | Background | Ravikumar R, Jassem W, Mergental H, Heaton N, Mirza D, Perera MT, Quaglia A, Holroyd D, Vogel T, Coussios CC, Friend PJ. Liver Transplantation After Ex Vivo Normothermic Machine Preservation: A Phase 1 (First-in-Man) Clinical Trial. Am J Transplant. 2016 Jun;16(6):1779-87. doi: 10.1111/ajt.13708. Epub 2016 Mar 7. |