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The Holy Grail: Transplantation Data and Current Trials. September 26, 2013 Donor Management Summit Darren Malinoski, MD, FACS Associate Professor of Surgery Oregon Health & Science University. Donation and Transplantation Research.
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The Holy Grail:Transplantation Data and Current Trials September 26, 2013 Donor Management Summit Darren Malinoski, MD, FACS Associate Professor of Surgery Oregon Health & Science University
Donation and Transplantation Research • Goals: increase the quantity and quality of organs available for transplantation • Donor management guided by many stimuli • Initially theoretical • Anecdotal • Based on retrospective data • Before vs. after data • Prospective observational/interventional data • Randomized controlled trials
Donation and Transplantation Research • To increase the quantity of transplanted organs • Increase the number of donors • Improve donor management / critical care • Meet transplant center acceptance criteria • Donor Management Goals • Specific interventions • Alter transplant center acceptance practices • Link donor management goals / critical care values / interventions to graft outcomes • Inform decisions and optimize existing resources
Donation and Transplantation Research • To increase the quality of available organs • Improve donor management / critical care • Meet traditional endpoints • Meet newly identified endpoints • Utilize newly identified interventions • Innovation in graft preservation • Ex-vivo interventions • Improve recipient medical care and surveillance
Donation and Transplantation Research • Investigators/Drivers: • Transplant centers • OPOs • Donor hospital intensivists/trauma surgeons • Scope: • Local • National • Regional • Data sources • Extensive recipient data with limited donor data • General donor and recipient data – UNOS/SRTR • More granular donor data with limited recipient data
Region 5 Efforts • Retrospective
Region 5 Efforts • Prospective observational / interventional
Region 5 Efforts • Prospective observational / interventional
Region 5 Efforts • Prospective randomized • CTDN – albuterol • CTDN – tight vs. moderate glucose control • CTDN/OneLegacy – therapeutic mild hypothermia
HRSA-funded trialsClinical Interventions to Increase Organ Procurement - CIOP
HRSA-funded trialsClinical Interventions to Increase Organ Procurement - CIOP
Donation and Transplantation Research • Where do we want to be? • National database • Adequate power • Granular donor and recipient data • Automated data collection • Immediate availability of data to guide performance improvement • Infrastructure for donor intervention trials • Foster culture of research within the community of practice • Federal funding
How do transplant physicians currently decide to accept or decline organs?