Organ Preservation
Conditions
Keywords
SNMP, Preservation, Transplantation, Kidney
Brief 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.
Detailed description
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.
Interventions
OTHERSub-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.
Sponsors
Indiana University Health
University of Miami
MOUNT SINAI HOSPITAL
University of Wisconsin, Madison
Erie County Medical Center, Buffalo, NY
Duke University Hospital, USA
Barnes-Jewish Hospital
Edward Hines Jr. VA Hospital
34 Lives, PBC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft Survival | 1- and 3-months post-transplant | Donor kidney survival |
| Patient Survival | 1- and 3-months post-transplant | Recipient survival |
| Serum Creatinine (sCr) | 1- and 3-months post-transplant | Recipient sCr |
| eGFR | 1- and 3-months post-transplant | Recipient estimated glomerular filtration rate |
| 7-Day Delayed Graft Function (DGF) | 7 days post-transplant | Requirement for dialysis within first 7 days post-transplant |
| Long term data collection- Patient Survival | Annually, up to 3-years post-transplant | Patient survival |
| Long term data collection- Serum Creatinine | Annually, up to 3-years post-transplant | Recipient sCr |
| Long term data collection- eGFR | Annually, up to 3-years post-transplant | Recipient estimated glomerular filtration rate |
| Long term data collection- Graft Survival | Annually, up to 3-years post-transplant | Graft survival |
Countries
United States
Outcome results
None listed