Organ Care System (OCS™) Liver 'REVIVE' Trial
Research type
Research Study
Full title
Single Arm Prospective trial to Evaluate the Safety and Performance of the Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS™ Liver 'REVIVE' Trial).
IRAS ID
167906
Contact name
Magdy Attia
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Nationally 12-18% of patients whilst waiting for a liver transplant either die or become too ill for a transplant. To bridge the gap between demand and supply, many UK transplant units need to utilise organs from both normal and questionable donors. Liver discard rates from questionable donors remains high due to lack of objective assessment with existing cold storage and preservation methods. Efforts to improve assessment, preservation and utilisation of these organs are much needed.
New technologies to improve preservation and provide objective data on the quality of an organ have gained recent interest namely blood based normothermic perfusion system. TransMedics® has developed a portable, warm blood perfusion system that allows for ‘a living organ transplant’. This technology, called the Organ Care System (OCS™), is designed to maintain organs in a warm (physiological), functioning state outside the donor to facilitate continuous clinical evaluation. Using the same technology, TransMedics® have developed similar machines that are now used successfully in heart and Lung transplantation.
Based upon overwhelming supportive pre-clinical studies on safety, feasibility and potential benefits of warm machine perfusion, we expect that the use of OCS™ Liver is safe and the assessment capabilities are expected to perform as intended.
The proposed study aims to evaluate the safety and performance of OCS™ Liver for preserving and assessing donor livers considered for Transplantation. Twenty five donor livers that fulfil the inclusion criteria will be preserved and assessed in OCS™ Liver.
We believe OCS™ Liver would help to expand the current donor pool and reduce the death on the waiting list by improving the utilisation rates of questionable livers.Summary of Research
The REVIVE trial included 25 subjects transplanted in Europe with Organ Care System (OCS) preserved donor livers, including 7 subjects who received DCD (Donors after Circulatory Death) livers. The OCS performed as intended and 100% of the donor livers were transplanted.Summary of Results
Patient and graft survival at 30 days was 100%. The incidence of early allograft dysfunction (EAD) was 20%. These data provide additional supporting evidence for the safety and effectiveness of the OCS Liver System.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0378
Date of REC Opinion
7 Oct 2015
REC opinion
Further Information Favourable Opinion