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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.

eye icon Public feedback on the protocol

To offer feedback about the protocol, please submit an e-mail using the button below. Please also indicate whether you wish to have your name and/or an organizational affiliation displayed. All feedback, subject to the OPTN Standards for Public Comment, will be posted to this page.

Send feedback on this protocol

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.

Katelyn Faust | 05/21/2024

We are in support of this protocol and, as an aggressive center, frequently utilize high KDPI kidneys. We do have concern regarding the availability of biologic medications such as Belatacept to patients who accept these organs and are likely to have delayed graft function. We are also concerned that this would launch near the time when the IOTA model does, and while both drive the process around organ acceptance, they do it in a very different way. How would the OPTN keep transplant programs from becoming overwhelmed by these major changes? With the new KDPI calculation (excluding race and hepatitis C), there will presumably be fewer high KDPI kidneys. How does this fit in to this protocol? We would like to see the criteria for participation for both OPOs and transplant centers to understand how selection will occur. We look forward to hearing more about this protocol and the next steps needed to be a participating transplant center.

Kristi Valenti | 05/23/2024

Good Morning: I am looking for clarification on the “simultaneous offers.” Does this mean simultaneous offers to multiple transplant centers? Or simultaneous offers for the same transplant center and different recipients.

If simultaneous offers are sent to multiple transplant centers, I have concerns about this “first come, first serve” mentality. Being rushed to accept an organ does not allow for a thorough chart review of the donor to ensure the best possible outcome for our transplant recipient. I understand the need to find homes for these statistically difficult to place organs, but this should not come at the cost of our recipient’s safety and transplant success.

Caroline Jadlowiec, MD | 05/23/2024

I support this protocol proposal for improving efficiency and transparency in allocation of hard-to-place kidneys (KDPI >75%). While the message of wanting to include transplant centers that have not demonstrated a track record in accepting hard-to-place kidneys is understandable, I do have concerns that this will decrease the efficiency in the process and potentially reduce the impact of some of the metrics being monitored, such as cold ischemia time. I would propose that there be two arms to this proposal: One that only includes transplant centers that have demonstrated a track record in accepting these organs, and a second arm that includes all transplant centers, including transplant centers that have not previously shown similar organ offer acceptance patterns. Having data showing both arms would be meaningful in further refining and developing expedited placement.

Lisa Kayler | 05/23/2024

Most of our candidates will accept offers from 75-85, but not above 85. How was the 75 cut-off decided? Also post-recovery findings remain important for final decision-making.

Abraham Zawodni | 05/23/2024

Greetings and congratulations on the launch of this exciting PDSA. The protocol is precisely what the industry needs to attempt, it is truly thinking outside of the box (or pump?). Kudos on the intent to start small and this first cycle makes perfect sense. I will add that in the future, another tweak to consider is introducing a bit more competition to the accelerated placement target list. If competition is meant to drive improvement in the OPOs, then it should also have a place in allocation. Could there be a component tested in the future where there is an element of "first come, first serve" or the first transplant center to say "yes, send the kidney"? Any small nudge like this to the decision makers in acceptance can have significant impact. A low, mandatory response time of 30-minutes is good, but it's not significantly different from the conundrum we OPOs find ourselves in with the traditional Provisional Yes vs. Acceptance evaluation timeline for centers. In the end, careful alignment of incentives will be critical to minimizing CIT as much as possible. After all, with the kidney discard rate, truly CIT is the Enemy.