Normothermic Machine Perfusion - Usability Study
Research type
Research Study
Full title
Non-randomized, open-label, single-arm, clinical investigation to assess the usability of the OrganOx metra, for the normothermic perfusion of livers
IRAS ID
238441
Contact name
toni day
Contact email
Sponsor organisation
OrganOx Ltd
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The current standard preservation practice for livers to be retrieved for transplantation is using cold storage, until the organ is delivered to the donor hospital. However, there is accumulating evidence of the superiority of a more physiological approach using oxygenated blood at normal body temperature. Several studies, including two studies (~200 livers) using the OrganOx metra, demonstrate that the quality of preservation can be improved substantially by this warm preservation, by combining the avoidance of cooling with the maintenance of a supply of oxygen. Warm perfusion has the added advantage of allowing more effective assessment of the organs while on the circuit (using multiple perfusion dynamic and biochemical parameters), contrasting with more limited parameters available on the cold circuit. A number of controlled clinical studies have shown that the normothermically preserved liver can be transplanted reliably and successfully after warm storage. If these results were translated into clinical practice, this would generate a large source of donor organs.
The OrganOx metra was developed to provide an automated, transportable device based on normothermic perfusion. The device has been tested clinically and has demonstrated to be effective during clinical studies. The purpose of this study is to review the usability of the device. It is not intended this device will change current clinical practice and standards of liver transplantation surgery and patient aftercare, the device is for preservation of the liver only.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0015
Date of REC Opinion
31 Jan 2018
REC opinion
Unfavourable Opinion