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Pre-implantation Oxygenated Hypothermic Machine Perfusion Reconditioning after Cold Storage versus Cold Storage alone in ECD Kidneys from Brain Dead Donors

Trial categories: Other

Sponsoring organisation: University of Oxford

Every kidney donated after the death of a donor requires preservation. Preservation supports the kidney in resuming its function after transplantation. The same applies to the donor kidney allocated to you. This preservation can either be attained by storing the organ in a preservation solution or by additionally flushing the organ with a preservation solution during storage. Both methods are well-established standard procedures. The latter involves adding oxygen to the flushing solution by means of a specifically designed and certified perfusion machine. Previous research has shown that this method of preserving an organ may be beneficial.

What is the purpose of the study?

The purpose of this study is to investigate whether the technique of using a machine to preserve the kidney will help it to function better after it has been transplanted. We also want to find out if adding oxygen during the preservation of the kidney on the machine improves the function of the kidney after transplantation. We want to compare this method of kidney preservation to the standard method currently used in the UK and Europe, which is to preserve the kidney in preservation fluid in a box on ice. We will compare the two methods of preservation by assessing how the kidney functions after the operation. The study will involve 262 participants from the kidney transplant waiting lists in four European countries.

We are asking adult patients (older than 18 years old) who are currently on the kidney transplant waiting list at the participating transplant centres. You are being asked if you would like to take part in this research because you are on the waiting list to receive a kidney transplant and, in the opinion of the doctors looking after you, there are no other medical issues that would prevent you from taking part in the study. We would like to be able to study the different effects of the two preservation methods and to do that we would need to record some of your information and results for the purposes of the study. If you decide to take part you will be invited to complete and sign a consent form when you are called in to receive a kidney transplant.

What are the exclusion criteria?

You would not be able to take part in the study if:

  • you are younger than 18 years old
  • you are undergoing transplantation of another organ as well as a kidney
  • your medical team feels for any reason you are not suitable to take part; your medical team will discuss this with you
  • you may be pregnant.

What happens when a kidney is found for me?

When a kidney is identified for you, the Transplant Coordinator will ask whether you are willing to take part in the study, and if so, you will be asked to sign a consent form to confirm you are happy to take part.

The total duration of the study is approximately 12 months.

You will be asked to complete a short questionnaire when you attend for your transplant and at your follow-up visits at around 3 months and 12 months after your transplant, which will ask about your daily activities and quality of life.