Hypothermic Oxygenated machine PErfusion, better organ quality saves lifes

Human Trial

Hypothermic oxygenated perfusion (HOPE) of human liver grafts before transplantation (NCT01317342).

 

Objective

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To test machine liver perfusion against standard cold storage before liver transplantation.

The suggested study will demonstrate, for the first time, in a randomized trial the effect of a highly simplified endischemic perfusion technique in human liver grafts in terms of graft dysfunction and biliary injury. In case of convincing success, we postulate a high acceptance rate among transplant surgeons, since this approach can be easily applied in any centre worldwide.

 

Study design

The study population consist of patients undergoing liver transplantation (University Hospital Zürich, Switzerland). Eligible patients will be randomized in 2 groups, a perfusion group (HOPE) and a control group. Standard liver procurement will be performed at the site of organ donation, and the cold stored organ will be transported afterwards to our centre. Following backtable preparation, short term hypothermic oxygenated perfusion (HOPE group) for one hour will be performed vs continued cold storage (CS, Control group). Machine perfusion will not delay the implantation of the liver.

 

The primary endpoint will be major postoperative complications (Grade ≥ III) according to the established Clavien classification. Further secondary endpoints are postoperative peak ALT levels in the serum (Area under the curve), duration of hospital and ICU stay, costs, and recipient and graft survival. Additionally, we will assess liver graft biopsies taken at the end of liver transplantation for markers revealing inflammatory response and reperfusion injury.


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