Pilot Randomized Trial Exploring the Impacts of Deceased Donor Kidney Procurement Biopsies on Organ Evaluation and Transplant Outcomes.
Lentine, K. L., et al. (2025).Cureus 2025; 17(4): e81728.
Aims
This study aimed to assess whether it was feasible to conduct an RCT which examined the impact of postponing the release of procurement biopsy information at the time of offer, on kidney graft utilisation and posttransplant outcomes.
Interventions
Deceased donors were randomised to either the frozen section biopsy group or permanent biopsy processing (delayed biopsy information) group.
Participants
11 deceased donors for a consented transplant candidate were randomised.
Outcomes
The main outcomes of interest were organ disposition, kidney yield per the Scientific Registry of Transplant Recipients (SRTR) formula, cold ischemia time, delayed graft function, estimated glomerular filtration rate (eGFR), patient death and graft loss.
Follow-up
1 year posttransplantation
CET Conclusions
This small pilot study investigated the impact of randomising the availability of donor biopsies for kidney offers with a KDPI > 50% to either immediate availability (frozen section) or delayed processing. The authors looked at impact on organ utilisation and post-transplant outcomes. 85 recipients were consented to participate, with 13 donors randomised. No differences were seen in outcomes. The study is underpowered to show any clinical differences but does highlight the challenges of this type of research. Patients were randomised on the waiting list with a high attrition rate due to living donor transplantation or receipt of ineligible kidneys. There were also a number of crossovers. A much larger national study (the PITHIA study) has recently reported in the UK, with similar findings: making biopsies routinely available during the offering process does not appear to impact utilisation or outcomes.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT03837522