Sub-Normothermic Machine Preservation and Assessment
Sub-Normothermic Machine Preservation and Assessment: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
16 Years
Max age
75 Years
Healthy volunteers
No
Donor Kidney Inclusion Criteria:
* Be considered HTP, by receiving refusals from every transplant center within the 250 nm allocation radius or similar definition by the local OPO.
* From a Male or female deceased donor, aged 16- 75 years old.
* Kidney initially procured, preserved, and packaged with intent to transplant.
* LAP provides informed consent for organ donation for transplant and research purposes.
* The HTP donor kidney must be allocated to a participating transplant center by a participating OPO, and the transplant center makes the decision to send kidney to Sponsor's central preservation and assessment facility for SNMP assessment and preservation prior to determining suitability for allocation.
Donor Kidney Exclusion Criteria:
* From a Donor with pre-admission diagnosis of end stage renal failure.
* Obvious surgical damage to artery(s), vein(s), or ureter(s) preventing machine perfusion.
* From a donor with confirmed HIV (+), HBVSAg (+) and/or HCV NAT (+) serology results.
* No LAP consent for both transplant and research purposes.
* Cannot arrive to Sponsor's central preservation and assessment facility before reaching 24 hours of cold ischemic time (CIT).
Primary outcome measure(s)
Transplant Allocation Success — 1 year 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.
Trial sites (8)
Facility
City
Region
Status
Edward Hines, Jr. VA Hospital
Chicago
Illinois
Indiana University Health
Indianapolis
Indiana
Barnes-Jewish Hospital
St Louis
Missouri
Erie County Medical Center
Buffalo
New York
New York University Langone
New York
New York
The Mount Sinai Hospital
New York
New York
Duke University
Durham
North Carolina
University of Wisconsin School of Medicine and Public Health
Madison
Wisconsin
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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