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Accelerated placement of hard-to-place kidneys

Protocol 1: Pre cross clamp placement of KDPI 75-100 Kidneys

Submitted by: Rescue Pathways Workgroup of the Expeditious Task Force

Protocol status: Open for feedback until 5:00pm ET on May 30th, 2024

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Protocol summary

  • The protocol applies only to offers of deceased donor kidneys with a Kidney Donor Profile Index (KDPI) of 75 percent or higher. The KDPI value reflects the likely length of kidney function (graft survival) as compared to all deceased kidney donors; a higher value indicates the kidney will be less likely to function as long as a kidney from a lower KDPI donor (see a video that explains the KDPI score and how it is used).
  • Research shows that kidneys from donors with a KDPI of 70 percent or greater are used for transplant much less frequently than kidneys with a lower KDPI value, with the non-use rates increasing as the KDPI percentage increases.
  • The protocol will seek up to 5 organ procurement organization (OPO) participants, which vary in characteristics such as geographic location, population density and medical characteristics of donor population. The protocol will also seek kidney transplant program participants that have a demonstrated history of accepting and using kidneys from donors with a KDPI of 75 percent or higher.
  • Participating transplant programs will have a pre-identified list of transplant candidates willing to accept kidneys from deceased donors with a KDPI of 75 percent or higher. They may identify two transplant candidates from their program for whom they would accept such an offer.
  • For deceased kidney donors with a KDPI of 75 percent or higher, a participating OPO will make offers in the following sequence prior to organ recovery (specifically before the donor’s aorta is cross-clamped):
    • High priority classifications for kidney transplant candidates as addressed in OPTN Policy 8.4 (Kidney Allocation Classifications and Rankings)
    • Candidates pre-identified by participating kidney transplant programs to be considered for such offers
    • The OPO may then continue to offer the kidney(s) to remaining potential transplant recipients in the order they appear on the match run, or increase the number of simultaneous offers to a set number of potential recipients at a time.

Intended goals and outcomes

  • Increase the likelihood of kidney placement by identifying potential candidates ahead of the match and prioritizing them at an early stage of the placement process

Observed results if protocol is in use

A number of OPOs have employed similar strategies for placement of kidneys from high-KDPI donors. The workgroup is not aware of any that have used the 75 percent KDPI stratification. Of OPOs that have such practices, many start with a higher KDPI threshold, such as 85 percent.

Proposed evaluation metrics

  • The number and rate of kidneys from this group of donors used for transplant will be compared before and during the trial period.
  • Transplant allocation and usage will be monitored throughout the trial period. The protocol will be discontinued if adverse effects are observed, such as (but not limited to) a decrease in organ usage or effects such as an unanticipated rate of early graft loss or delayed graft function.

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Nicole Patterson | 05/14/2024

I like the idea of this protocol. We utilize KPDI >85 kidneys frequently and are an aggressive center. From a transplant center perspective, these kidneys oftentimes are kidney-only donors. I would urge OPO’s to ensure flights or travel are reviewed or looked at prior to going to the OR. Often we have to decline kidneys due to cold times. We have had several offers at the 15 – 18 hour mark and we would take those without hesitation however there are no flights available for another 10-12 hours. Forcing us to turn down the kidney offer.

Larry Suplee | 05/16/2024

Good morning- I was excited to see the recent release of the first protocol for hard-to-place kidneys and look forward to the townhall on Monday. Since February, Gift of Life has been engaged in a small, pre-recovery PDSA for kidney donors with a KDPI of 75% or higher with a small number of centers who agreed to our pre-recovery expectations that include: identifying, checking, clearing patients, donor review with all decision makers and completion of a final cross match. The limiting factor thus far has been the number of centers willing to engage and fully commit to these types of kidney donors pre-recovery. With our volume and proximity to several kidney centers, we eagerly wish to participate in this protocol. I look forward to hearing more about this and the next steps needed to be a participating OPO.

Emily Perito | 05/20/2024

I appreciate that this protocol (1) specifically focuses on kidneys at high-risk of non-use (2) specifically preserves access for high priority candidates by explicitly stating that they will NOT be skipped in the match runs and (3) specifies that the variance will be piloted in a limited number of OPOs – with very clear guidance to transplant centers about who will be eligible to receive the expedited placement organs. By limiting a programs’ pre-identified list of patients, I also hope that this will encourage ongoing sharing between OPOs and multiple centers – as opposed to set-ups that would only allow 1 or 2 transplant centers (and their patients) to benefit from the variance. I hope that the Task Force continues to require these types of safeguards in future protocols.