Transplantation is a definitive treatment option for many people suffering from end-stage organ failure. Organ supply, however, far exceeds the supply. While recent studies suggest that improved management of deceased organ donors may increase transplant rates and allograft function, research to support best practices in donor management is sparse. The DONATE Pilot Observational Study aims to identify and to address logistical and regulatory complexities prior to embarking upon a national observational study that will improve the care of organ donors and lay the foundation for future clinical trials.
This 12 month prospective cohort study was conducted between September 2015 - April 2017 in the intensive care units (ICUs) of 8 Ontario and Quebec hospitals enrolled consecutively consented adult deceased donors [donation after neurological determination of death (DND) and donation after circulatory determination of death (DCD). The primary outcomes of this pilot study included the successful application of a waived research consent model, the time to complete the case report forms (CRF) and the completeness of transplant recipient data. Detailed data from various hospital sources and provincial organ donation organizations included death determination procedures, cardiopulmonary monitoring technologies, basic and advanced life sustaining therapy, general prophylactic interventions, organ donation specific therapies and clinical complications, defined a priori, from one day prior to donation consent up to the time of organ recovery. We also recorded specific limited data about the transplant recipients.
In collaboration with ethicists, lawyers and privacy officers, all hospitals obtained authorization to implement this study with a waiver of research consent. The study, includes 180 consecutive deceased donors (58% DND; 42% DCD). The most common critical illness leading to organ donation was global anoxic brain injury (n = 37, 20.,6%). The mean time from donation consent to organ recovery was 2.39 days (SD = 0.72). Research coordinators estimated that prospective data completion required 5-7 hours per participant, but retrospective approaches required more time. With formal data sharing agreements, we obtained recipient data.
This pilot study identified and addressed some unique logistical and regulatory organ donation research challenges. The process provides a framework for addressing the same issues, and refining data collection, in the context of an upcoming national prospective cohort study. Clinical findings from the national cohort will inform the design of future trials in organ donor management.
Canadian Critical Care Trials Group. Canadian National Transplant Research Program.