About this trial
The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after circulatory death (DCD) is superior to NRP alone. The researchers will learn if the combined use of these technologies provides a benefit in terms of kidney transplant outcomes. The researchers will also learn about the patient quality of life after these transplants and if the use of these technologies is cost efficient. The main questions it aims to answer are:
* Does NRP +HMPO2 provides a better DCD kidney function at 1 year post-transplant compared to NRP alone. * Are the postoperative complications and outcomes different between the two groups? * Is the quality of life of recipients different between the two groups? * Is the use of NRP +HMPO2 a cost effective strategy? Researchers will compare NRP and HMPO2 with NRP alone to see if the combined use of the technologies provides better transplant outcomes.
Participants will:
* Receive a kidney treated with one of the two strategies. * Visit the clinic as per usual clinical practice for checkups and tests * Report on their quality of life pre and post transplant * Undergo a kidney biopsy at one year to forecast long term transplant function
Eligibility criteria
Qualifiers
All DCD donors in Sweden with consent for organ donation and where organ recovery is undertaken with NRP.
Kidney deemed transplantable by donor surgeon and responsible transplant surgeon (not discarded before or during procurement)
All adult patients (>18 yrs old) eligible for renal transplantation during study duration.
Recipient consented for surgery, matched to a DCD kidney.
Disqualifiers
Paediatric patients (<18 yrs old).
Participation in other clinical drug or medical devices trials.
Patient subject to combined transplant of kidney + other organ.
Trial design
Treatments tested in this trial
- Ex situ hypothermic oxygenated machine preservation
Treatment groups
Sponsors and collaborators
Karolinska University Hospital
Lead sponsor
Uppsala University Hospital
Collaborator
Skane University Hospital
Collaborator
Sahlgrenska University Hospital
Collaborator
Karolinska University
Collaborator