Abstract: TH-PO1164
A Randomized Trial of Mild Hypothermia and Machine Perfusion in Deceased Organ Donors for Protection Against Delayed Graft Function in Kidney Transplant Recipients
Session Information
- Late-Breaking Clinical Trials Posters
October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- No subcategory defined
Authors
- Malinoski, Darren, Oregon Health & Science University, Portland, Oregon, United States
- Swain, Sharon L, Donor Network West, San Ramon, California, United States
- Groat, Tahnee, Oregon Health and Science University, Portland, Oregon, United States
- Garza, Alex, UNOS, Richmond, Virginia, United States
- Niemann, Claus, UCSF School of Medicine, San Francisco, California, United States
Group or Team Name
- Donor Management Research Initiative
Background
Machine perfusion (MP) of kidneys from deceased donors has been increasingly adopted by many centers even though clinical and cost effectiveness studies remain uncertain in the United States. We investigate the effectiveness of MP compared to mild hypothermia which recently has been shown to be protective against DGF (1).
Methods
The trial was approved by the IRB of UCSF (# 17-21768). Donors are not considered human subjects under federal regulations. A waiver of informed consent for recipients is acceptable based on the same federal regulations.
A pragmatic multi-site randomized controlled trial that bases enrollment on each Organ Procurement Organization (OPO) current pumping criteria. There are two main groups of deceased donors (DNDDs), (1) those that are "pump eligible" based on current practice and (2) those that are lower risk and whose kidneys do not receive MP ("not pump eligible"). In this trial, "pump eligible" DNDDs are randomized to one of three groups : (1) normothermia (36.5-37.5 C) plus MP of both kidneys (standard of practice control group), (2) mild hypothermia (34-35 C) plus MP of the left kidney only, and (3) mild hypothermia plus MP of the right kidney only. In this manner, the same number of kidneys are randomized to each of the three treatment strategies (MP alone,mild hypothermia alone, or MP+hypothermia). NCT02525510
Results
Three OPOs joined the trial within the first 12 months and 709 donors were screened for eligibility, 559 (78.8%) had research authorization. 353 were excluded with DCD, age the most common reason for exclusion. 203 DNDDs were enrolled in the trial. There were 2 reportable events (bradycardia and ectopy with low BP) with no adverse events that required intervention. In 40 kidneys randomized to pump-eligibility, intended pump assignment could not be followed. Notably, 28 kidneys (22.5% of pump eligble) could not be pumped when supposed to, mainly because of anatomy and logistics.
Conclusion
Additional OPOs will join within the next 6 months allowing enrollment to increase above 10/week. Importantly, a significant portion of pump eligble kidneys could not be pumped which demonstrates the need to identify additional protective strategies for kidneys at risk for DGF and poor function.
1. N Engl J Med. 2015 Jul 30;373(5):405-14
Funding
- Private Foundation Support