Ex-vivo normothermic perfusion in DCD kidney transplantation
Research type
Research Study
Full title
A Randomised controlled trial of Ex-vivo Normothermic Perfusion versus Static Cold Storage in Donation after Circulatory Death Renal Transplantation
IRAS ID
179752
Contact name
Michael L Nicholson
Contact email
Sponsor organisation
Cambridge University NHS Foundation Trust and The University of Cambridge
Clinicaltrials.gov Identifier
15/EE/0356, 15/EE/0356
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
To make more kidneys available for transplantation it is necessary to use organs from less optimal donors. These include the use of kidneys that are retrieved after the heart has stopped, termed donation after circulatory death (DCD) donors.
These kidneys suffer a period of damage that causes a high percentage of them not to function immediately after transplantation. This doesn’t appear to reduce the long-term survival of the kidney but can lead to prolonged hospital stay, additional requirement for dialysis therapy and complications in the immediate phase after transplantation.
Under normal circumstances kidneys are preserved by flushing and cooling with preservation solution then stored on ice until it is ready for transplantation. Nonetheless, these conditioning can increase the risk of early graft dysfunction, particularly in DCD donor kidneys.We have developed a new technique of kidney preservation that involves warming the kidney with a blood-based solution for a short period just prior to transplantation. This is called ex-vivo normothermic perfusion (EVNP). Restoring circulation and providing the kidney with oxygen in a protective environment can improve the condition of the kidney enabling it to function better after transplantation.
Approximately 400 patients who are waiting for a kidney transplant will be recruited into the study. Only kidneys from DCD donors will be included in the trial. They will be randomly allocated to one of two groups; the kidney will either undergo the standard cold storage or EVNP. Three centres in the UK will be involved in the study (Cambridge, Guy’s & St Thomas’s and Newcastle). Consent will be taken from the patients and they will remain in the trial for 12 months.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0356
Date of REC Opinion
17 Nov 2015
REC opinion
Further Information Favourable Opinion