Abstract: SA-PO954
Pilot Randomized Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies
Session Information
- Transplantation: Clinical - 3
October 26, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- 2102 Transplantation: Clinical
Authors
- Lentine, Krista L., Saint Louis Univ., St. Louis, Missouri, United States
- Fleetwood, Vidya, Saint Louis Univ., St. Louis, Missouri, United States
- Caza, Tiffany, Arkana, Little Rock, Arkansas, United States
- Caliskan, Yasar, Saint Louis Univ., St. Louis, Missouri, United States
- Marklin, Gary F., Mid-America Transplant, St. Louis, Missouri, United States
Background
Kidney biopsies obtained during organ procurement are often used in acceptance decisions, but supporting evidence is controversial. We conducted a pilot randomized controlled trial (RCT) to help assess impacts of deferring release of procurement biopsy information at the time of offer (in this design, through permanent processing).
Methods
This pilot, multicenter RCT involved 1 Midwest organ procurement organization (OPO) and 2 local transplant centers (7/2019-7/2022 | ClinicalTrials.gov NCT03837522). Waitlisted candidates were approached for consent, such that if offered a kidney from an eligible deceased donor (DD), the DD could be randomized (Fig 1A). Criteria for routine DD biopsy included KDPI >50% or KDPI components. Eligible DDs for consented recipients were randomized to immediate (frozen) versus delayed (permanent) biopsy processing. Outcomes were assessed in linked SRTR data.
Results
85 candidates were consented; 25 were disenrolled (Fig 1B), most commonly due to receipt of an imported and/or previously biopsied kidney at another OPO, surgeon request for immediate biopsy (25%), or DD not meeting routine biopsy criteria (20%). 12 DDs were randomized for eligible candidates. 2 kidneys from 2 study DDs were not used, both in the frozen group. 12 kidneys from 10 randomized DDs were transplanted in study recipients. Delayed graft function (DGF) occurred in 3/6 (50%) in frozen and 2/6 (33%) in permanent groups. There were no graft failures within 1 y, and 1 death (frozen group).
Conclusion
An RCT of impacts of DD procurement biopsy information on transplant outcomes faces challenges, including effort to consent waitlist candidates and high disenrollment for reasons including rising organ imports. This pilot did not suggest safety concerns for delayed biopsy information.
Funding
- Private Foundation Support