GRONINGEN, The Netherlands, December 31 /PRNewswire/ -- Results from a landmark trial published today in the New England Journal of Medicine, show that in transplanted kidneys preserved and transported in a specially designed machine (LifePort Kidney Transporter) the odds for experiencing a delay in recovery of kidney function are 43% lower, and that these kidneys are 48% less likely to fail within a year compared to those stored in the traditional box of ice (cold storage)(1). The study was the first randomised, prospective trial to compare these two methods of preservation.
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Depending on the type of deceased donor,* 15-50 per cent of transplanted kidneys do not function immediately following transplantation and many patients will require dialysis treatments for a certain period after transplantation(2,3,4). As a result, these kidneys have an increased risk of rejection(3) and survival of the kidney graft may be compromised. This in turn will put pressure on the already long transplant waiting lists(3,4).
This is a truly important finding for the thousands of people on transplant waiting lists around the world, said Rutger Ploeg, coordinating principal investigator for the trial and Professor of Transplant Surgery at the University Medical Center Groningen, The Netherlands. The ongoing challenges we face today are a global shortage of organs for transplantation and that a growing number of the organs available for transplantation are often from older donors or from people with more complex medical conditions. Evidence tells us that these kidneys may not work as well immediately post transplantation and as a result may not last as long. This trial shows us that, regardless of the type of donor, by using machine preservation we can ensure that there will be more kidneys available for transplantation and that they will be in better health.
Cyril Moers, lead author and clinical research trainee at the University Medical Center Groningen, added The results of the study clearly show the advantages of machine preservation over the traditional box of ice. Although machine preservation has been around for quite some decades, a large randomised clinical trial investigating its merits had never been conducted. Our international study for the first time demonstrates that any deceased donor kidney will benefit from this preservation method.
Facts about the trial
- The Machine Preservation Trial was an investigator-driven study, run by an independent scientific steering committee across The Netherlands, Belgium and the German federal state of North Rhine Westphalia, in close collaboration with Eurotransplant International Foundation (the international organ exchange organisation for Austria, Belgium, Croatia, Germany, Luxembourg, The Netherlands and Slovenia) as the central trial assistance desk. Principal investigators were Rutger Ploeg (Groningen, The Netherlands), Andreas Paul (Essen, Germany), and Jacques Pirenne (Leuven, Belgium).
- During the time of the trial, every deceased donor in the area was considered for inclusion in the study. 336 pairs of kidneys were enrolled in the study. One kidney from each pair was randomly assigned to machine preservation, and the other one to cold storage. Kidneys were transplanted in recipients across the Eurotransplant area.
- The manufacturers, Organ Recovery Systems of Chicago, USA provided the LifePort Kidney Transporters used in the study. The machines were used for the preservation and transport of kidneys from organ recovery until transplantation.
- The primary endpoint was delayed graft function defined as the need for dialysis in the first week post transplantation. Evidence suggests that organs that do not function immediately after transplantation have an increased risk of rejection and survival of the transplanted kidney may be inferior.(2)
- Secondary endpoints included: patient and graft survival up to 12 months after transplantation, duration of delayed graft function, length of stay in hospital, primary non-function of the transplanted kidney, serum creatinine and clearance after transplantation, acute rejection and calcineurin inhibitor toxicity.
Results from the study
- Machine perfusion significantly reduced the risk of delayed graft function compared to cold storage. 70 out of 336 kidney recipients in the machine perfusion group developed delayed graft function compared with 89 out of 336 patients in the cold storage group (adjusted odds ratio 0.57; P=0.01).
- In case delayed graft function occurred, its duration was shorter after machine perfusion compared with cold storage (10 days vs. 13 days; P=0.03).
- One year graft survival was superior in the machine perfusion group (94% vs. 90%; P=0.04) and machine perfusion was associated with a reduced risk of graft failure in the first year post-transplant (hazard ratio 0.52; P=0.03).
- Serum creatinine values were significantly lower for machine perfused kidney recipients compared to those cold stored in the first two weeks post transplantation (P=0.01).
- There were no significant differences observed for the other secondary endpoints.
- No serious adverse events were directly attributable to machine perfusion.
Facts about transplantation
- More than 1.5 million people worldwide suffer from end stage renal disease.(5)
- In 2008 in the USA alone, for example there are currently 82,435 people waiting for a kidney transplant. This year 4,213 kidneys have been recovered from deceased donors(6)
- Eurotransplant International Foundation (Eurotransplant) is the international organ exchange organisation for Austria, Belgium, Croatia, Germany, Luxembourg, The Netherlands and Slovenia and serves a population of 118 million.
- In the Eurotransplant area there are currently 10,719 people waiting for a kidney transplant (active waiting list of September 30, 2008)(7).
- In 2007, 3,420 people received a kidney transplant in the Eurotransplant region(7).
Notes to Editors:
* Deceased donors include:
- Brain dead donors - patients who meet the legal and medical criteria for brain stem death, whose organs are removed for transplantation.
- Donors after cardiac death (DCD) - organ donors who have been declared dead because their heart has stopped (also called non-heart-beating donors) .
- Expanded criteria donors (ECD) - brain dead donors or donors after cardiac death over the age of 60 years, or between 50 and 60 years with additional health conditions such as high blood pressure, stroke, or a sub-optimal kidney function prior to organ retrieval.
Trial organisational structure
Scientific steering committee
Rutger J. Ploeg (coordination principal investigator, The Netherlands)
Andreas Paul (principal investigator, North Rhine Westphalia, Germany)
Jacques Pirenne (principal investigator, Belgium)
Cyril Moers (secretary)
Mark-Hugo Maathuis (regional perfusion center liaison)
Jaap Homan van der Heide (member)
Ernst van Heurn (member)
Jean-Paul Squifflet (member)
Jürgen Treckmann (member)
Central trial assistance
Arie Oosterlee (Eurotransplant, general director)
Axel Rahmel (Eurotransplant, medical director)
Jacqueline Smits (Eurotransplant, statistician)
Margitta van Kasterop-Kutz (Eurotransplant, data manager)
Günter Kirste (Deutsche Stiftung Organtransplantation, general director)
Ulrike Wirges (Deutsche Stiftung Organtransplantation, director North Rhine Westphalia)
Regional perfusion center coordinators
Henri Leuvenink (Groningen, The Netherlands)
Frank van Gelder (Leuven, Belgium)
Bogdan Napieralski (Essen, Germany)
(1) Moers C, Smits JM, Maathuis M-H J et al. Machine perfusion or cold storage in deceased donor kidney transplantation. New England Journal of Medicine 1. N Engl J Med 2009; 360:7-19
(2) Koning OH, Ploeg RJ, van Bockel JH et al. Risk factor for delayed graft function in cadaveric kidney transplantation: a prospective study of renal function and graft survival after preservation with University of Wisconsin solution in multi-organ-donors. European Multicenter Study Group. Transplantation. 1997 Jun 15;63(11):1620-8.
(3) Daly PJA, Power RE, Healy DA et al. Delayed graft function: a dilemma in renal transplantation. BJU International 2005;96:498-501.
(4) Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet 2004; 364: 1814.
For further information or to request an interview with Professor Rutger Ploeg please contact: Press office: Mobile: +44-7-941989955 or University Medical Center Groningen, Department of Media Communication, Phone: +31-50-3616161