Scientific and clinical evidence

A robust, clinical-trial and publication evidence base supports use of the OrganOx metra^®

To date, hundreds of donor livers have been studied in normothermic machine perfusion trials around the world, including 220 livers that formed the Consortium for Organ Preservation in Europe (COPE) randomised controlled trial published in Nature in April 2018.¹ With clinical trials taking place across Europe and North America, the metra has an extensive evidence base.

Key trials and publications are summarised below.

Completed trials

COPE European Trial

The COPE (Consortium for Organ Preservation in Europe) trial is now complete and results were published in Nature (Nasralla D, et al. Nature. 2018;558(7703):50–56).

This was the first randomised trial to assess machine perfusion versus static cold storage in liver transplantation and included 220 transplantations. Compared with static cold storage, the OrganOx metra achieved a 50% lower level of graft injury despite a 50% lower rate of organ discard and a 54% longer mean preservation time.
Birmingham VITTAL Study

The Viability Testing and Transplantation of Marginal Livers (VITTAL) study started in 2016 at the Queen Elizabeth Hospital, Birmingham, UK. It is led by Professor Darius Mirza and Mr Hynek Mergental and was designed to determine if a declined liver is viable using normothermic machine liver perfusion (NMLP). It aims to establish the suitability of livers which have been declined by all UK liver transplant centres by monitoring their function on the OrganOx metra device; and transplant the liver if its function on the machine is satisfactory allowing it to be transplanted.

The clinical trial.gov identifier is NCT02740608
Edmonton

Dr James Shapiro and colleagues from the University of Alberta, Edmonton, Canada, have recently completed a study of the use of ex vivo normothermic machine preservation prior to liver transplantation following static cold storage using the OrganOx metra device. They were the first centre in North America to transplant a liver following normothermic preservation on the metra device (Bral M et al. Liver Transpl 2019; 25(6):848–858).

Ongoing trials

USA multi-centre RCT

Recruitment has started in this pivotal multi-centre randomised controlled trial in the United States. This study, operating under an Investigational Device Exemption (IDE) from the FDA, involves the transplant of up to 266 donor livers and is intended to test the safety and effectiveness of the OrganOx metra for preserving human livers prior to liver transplantation against the current standard of static cold storage.

The clinical trial.gov identifier is NCT02775162
Toronto

Dr Markus Selzner and colleagues from the University Hospital Toronto, Canada, have undertaken a study of ex vivo normothermic machine preservation using the OrganOx metra device. The results of the pilot phase of this study have been published.

The clinical trial.gov identifier is NCT02478151