The use of Polysol® as a wash-out and preservation solution in kidney transplantation: a pilot study in living (un)related donors

The increasing shortage of donor organs has led to the necessity of expansion
of the donor pool. Since current organ preservation methods do not suffice,
improvement of preservation methods is essential to increase the amount of
donor organs available for transplantation.
Recently, a new improved perfusion preservation solution, Polysol®, and
perfusion preservation system named Airdrive® have been developed for
hypothermic MP of kidney and liver grafts at the Surgical Laboratory of the
Academic Medical Center. Results of pre-clinical tests using Polysol® as a
flushing and preservation solution as well as in combination with the Airdrive®
show a significantly improved preservation quality of donor grafts, in
clinically relevant large animal transplantation models compared with current
clinical standards. Adverse reactions of the use of Polysol® have not been
encountered in the pre-clinical trials.
Polysol® as well as the Airdrive® perfusion system in combination with Polysol®
can be introduced in a clinical setting if the perfusion preservation solution
Polysol® can be considered *safe* for use in the clinical setting. Therefore, a
pilot-study using Polysol® for the preservation of kidney grafts is required.

Is Polysol® safe for use as a wash-out and preservation solution in kidney
transplantation?

In this prospective pilot study consenting kidney donors and their recipients
are recruited by the transplant surgeon. The (living) donors and their
recipients will be included when both the donor and the recipient have given
their informed consent. The donor will not encounter any additional risks other
than the usual risks involved with undergoing surgery. During surgery, after
retrieval of the kidney graft, the graft will be washed out of blood remnants
using Polysol®, a medical device, as a wash-out solution. Besides the use of a
new preservation solution, the entire transplantation procedure as well as the
investigational follow-up will be according to standard clinical practice for
living (un)related kidney transplantation (including blood and urine sampling).
During the wash-out and transplantation procedure, possible side-effects of the
use of Polysol® are monitored and recorded. During the revascularization
operation and shortly thereafter, vital parameters (a.o. pulse and blood
pressure) will be monitored to assess possible adverse reactions of the use of
Polysol®. Also, after the transplantation procedure has been completed, the
recipient will be observed to monitor possible adverse reactions of the use of
Polysol® for wash-out and preservation of the kidney graft. Postoperative
recovery during admission will be evaluated (physical condition, blood
sampling, urine sampling). After discharge, follow-up will continue until 1
month after transplantation.

The kidney graft recipients require a kidney transplantation, according to
standard clinical practice. Wash-out of the graft and hypothermic storage until
implantation into the recipient is also part of normal preparations for
transplantation of solid organs. As the living (un)related kidney
transplantation procedure requires an ex vivo wash-out of blood remnants, the
donor will not encounter any additional risks other than the usual risks
involved with undergoing surgery. In this study the clinical standard organ
preservation solutions for wash-out and preservation of the graft (Viaspan® or
Custodiol®) will be replaced by the new solution, Polysol®. There is not a
direct advantage for the kidney recipient, as the quality of a donor graft
retrieved from a *living donor* (therefore not subjected to a period of warm
ischemia) and the time for hypothermic storage both imply an *ideal* graft for
transplantation. Risks other than the usual risks associated with undergoing
(living donor) kidney transplantation to which a kidney recipient will be
subjected, are risks of the occurrence of adverse reactions of the use of
Polysol® for wash-out and preservation of the graft prior to transplantation.
As side effects that could be attributed to the use of Polysol® have not been
encountered in the pre-clinical trials, possible adverse reactions are not
anticipated, however need to be assessed in the clinical setting.