Attn: Transplant Administrators
We would like to inform you about a forthcoming study in brain dead organ donors, “A Randomized Trial of Mild Hypothermia and Machine Perfusion in Deceased Organ Donors for Protection against Delayed Graft Function in Kidney Transplant Recipients.” The anticipated start date will be determined after a 10 business day public comment period.
Read summary of study. The University of California San Francisco (UCSF) is the institution of record for this this study. The study was reviewed by a full Institutional Review Board (IRB) committee, which determined that recipients of organs from deceased organ donors enrolled in this clinical trial do not need to be consented due to the minimal risk involved. In addition, it was determined that transplant centers receiving organs from enrolled donors will not be engaged in research related to this study. Read IRB outcome letter.
The study was approved by the UNOS Region 5 Research Committee in October 2016, as well as the oversight bodies of all participating OPOs. In those cases where kidneys are shared outside of the DSA of participating OPOs, we would like to share this information for national awareness.
In order to keep the transplant community informed and allow transplant centers to use the information in making organ acceptance decisions, all organ offers from donors enrolled in the study will include a message in the “Donor Highlights” section of DonorNet® and a copy of the study summary and UCSF IRB letter will be attached to the record. Organ allocation/transplantation will occur based on standard practice, there will not be any interaction between the study team and the transplant recipients, and no additional data from organ recipients will be collected.
A two week public comment period will end on May 26, 2017. If you have questions about the study, please contact one of the following investigators or the study project manager:
Claus Niemann, MD, firstname.lastname@example.org, 415-502-2162
Darren Malinoski, MD, FACS, email@example.com, 503-701-7628
Study Project Manager: Alex Garza, alex.garza, 804-782-4883