A Single Center Clinical Trial to Assess Viability of High Risk Donor Livers using Hypothermic and Normothermic Machine Perfusion with Rewarming Phase Prior to Transplantation

Currently, there is a shortage of suitable donor livers. To expand the donor pool, livers from high risk donors, termed extended criteria donor (ECD) livers are increasingly accepted for transplantation. To counter the increased risk of developing severe complications, such as primary non function (PNF), machine perfusion can be used to evaluate and improve explanted livers. Normothermic machine perfusion (NMP) mimics the physiological state, and is conducted at 37 °C. The liver is metabolically active, allowing for ex-situ real-time assessment of viability. Hypothermic oxygenated machine perfusion (DHOPE), conducted at 4 - 14°C, has been demonstrated to improve the quality of ECD livers. This protocol is designed to assess viability of high risk donor livers using NMP, prior to transplantation. DHOPE, being superior in optimizing the quality of ECD livers will be conducted before gradually rewarming the donor liver to a normothermic temperature. During NMP a viability assessment will be carried out. Thus, high risk donor livers that would previously not have been accepted for transplantation, will be transplanted when meeting the viability criteria. Therefore, the donor pool might be expanded.

1.Potentially transplantable high risk donor liver grafts can be distinguished from non-viable high risk donor liver grafts using NMP.

2.DHOPE, prior to ex situ viability assessment, increases the odds of a high risk donor liver graft to be accepted for transplantation.

As described in boxes primary outcome(s) and secondary outcome(s)

Each high risk donor liver accepted for this study will undergo machine perfusion. First, DHOPE will take place, before gradually rewarming the donor liver to a normothermic temperature. Secondly, after rewarming, NMP will be performed to allow graft assessment.