Registry Analysis of Deceased Donor Kidney Transplant Outcomes With Normothermic Machine Perfusion (NMP)
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Chris Jaynes
- Enrollment
- 3,500
- Locations
- 1
- Primary Endpoint
- Delayed Graft Function
Overview
Brief Summary
This study uses existing transplant data obtained from a national public donor registry operated by the Organ Procurement and Transplant Network (OPTN) under Health Resources and Services Agency (HRSA) to evaluate outcomes associated with normothermic machine perfusion (NMP) of deceased donor kidneys. Currently, there is no method to study NMP kidney outcomes using the National Scientific Registry for Transplant Recipients (SRTR) national public registry, because no data field exists to identify which kidneys received NMP.
Detailed Description
This is a retrospective observational study using existing data from the Scientific Registry of Transplant Recipients (SRTR)/ Organ Procurement and Transplant Network (OPTN) public registry following a Research Plan approved by Health Resources & Services Agency (HRSA).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Requires kidney transplantation
Exclusion Criteria
- •\> 15 years old
Arms & Interventions
NMP Kidney Recipients
Patients receiving a kidney preserved and assessed using NMP
Outcomes
Primary Outcomes
Delayed Graft Function
Time Frame: 7 days post-transplantation
Requirement for dialysis immediately post kidney transplantation
Delayed Graft Function (DGF)
Time Frame: 7 days
Requirement for dialysis within 7 days post kidney transplantation
Secondary Outcomes
- Serum creatinine(Up to 3 years post-transplantation)
Investigators
Chris Jaynes
PI, co-CEO
34 Lives, PBC