Hypothermic Oxygenated Perfusion of Liver Grafts Donated after Circulatory Death in
Liver Transplantation - A Phase 1 Clinical Trial

This is a single center, prospective, non-randomized phase-I clinical trial to evaluate safety and feasibility of two hours of hypothermic oxygenated perfusion via portal vein and hep.atic artery at the end of static cold storage and before implantation. Six DCD liver grafts that are accepted for transplantation will be subjected to the intervention and the recipients will be followed for duration of six months posttransplantation. Primary endpoint is graft survival within six months

Two hours of end-ischemic hypothermic oxygenated perfusion via both the hepatic artery and the portal vein is feasible and safe in resuscitating liver grafts procured from donation after circulatory death donors.

- At patient inclusion

- Before liver transplantation

- Before hypothermic machine perfusion

- After hypothermic machine perfusion

- After reperfusion in the patient

- Posttransplantation at day 0 - 7, day of discharge, 1 month, 3 months and 6 months

Liver grafts transported to the transplantation hospital will be subjected to hypothermic oxygenated machine perfusion via the portal vein and hepatic artery after static cold storage and prior to implantation. The graft will be perfused for two hours using 3L of machine perfusion solution- Belzer UW® (Bridge-to-Life, Ltd., Northbrook, IL, USA) with added glutathione (3 mmol/L). The system will be temperature (10¡ã-12¡ãC) and pressure controlled with the pressures limited to a mean of 25 mmHg at the hepatic artery and 3 mmHg at the portal vein.

In this trial the Liver Assist® (Organ Assist, Groningen, The Netherlands) will be used as perfusion machine.