This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals.
This is an Observational study of a centralized kidney assessment facility providing brief sub-normothermic machine perfusion (SNMP) to HTP donor kidneys to provide transplant centers additional information for accepting HTP kidneys. This study is intended to collect data to evaluate the feasibility of a dedicated central service to determine if additional assessment data helps increase allocation to transplant centers. Transplantation will follow standard-of-care at each transplant center, including required post-transplant data collection, which must be reported to the OPTN registry by the center.
Study Type
OBSERVATIONAL
Enrollment
80
Human kidneys from HTP deceased donors will be transported to the Sponsor's central preservation and assessment facility and placed onto a machine perfusion system in a sterile operating room for a brief period of Sub-Normothermic Machine Perfusion (SNMP). Basic parameters including internal renal resistance, oxygen, and electrolyte levels will be recorded using standard point-of-care hospital analyzers. Accepted kidneys will be transported to a participating transplant center using a portable oxygenated LifePort Hypothermic Machine Preservation (HMP) device.
Edward Hines, Jr. VA Hospital
Chicago, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Erie County Medical Center
Buffalo, New York, United States
Transplant Allocation Success
The primary objective for this study is a 50% success rate or higher for allocation of Hard-to-Place (HTP) kidneys to a participating transplant center after sNMP assessment at the Sponsor's central facility.
Time frame: 1 year
7-Day Delayed Graft Function (DGF)
Requirement for dialysis within first 7 days post-transplant
Time frame: 7 days post-transplant
Graft Survival
Donor kidney survival
Time frame: 1- and 3-months post-transplant
Patient Survival
Recipient survival
Time frame: 1- and 3-months post-transplant
Serum Creatinine (sCr)
Recipient sCr
Time frame: 1- and 3-months post-transplant
eGFR
Recipient estimated glomerular filtration rate
Time frame: 1- and 3-months post-transplant
Long term data collection- Graft Survival
Graft survival
Time frame: Annually, up to 3-years post-transplant
Long term data collection- Patient Survival
Patient survival
Time frame: Annually, up to 3-years post-transplant
Long term data collection- Serum Creatinine
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New York University Langone
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Duke University
Durham, North Carolina, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Recipient sCr
Time frame: Annually, up to 3-years post-transplant
Long term data collection- eGFR
Recipient estimated glomerular filtration rate
Time frame: Annually, up to 3-years post-transplant