Novel Strategies for Innovating Deceased Donor Procurement

Study Overview
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Brief Summary
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Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys available for transplantation and the number of patients on the transplant waiting list. Increasing the quality of currently available donor kidneys would potentially improve the longevity of deceased donor kidney transplants by years, thus increasing the rate of transplantation patients on the kidney transplant waiting list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower total hospital charges. By innovating the organ donation process, such that deceased donor kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be possible to improve the quality of the kidney before transplantation, resulting in improved function after transplantation and increased longevity of these transplanted kidneys. Further, this improved kidney quality is highly likely to translate to reduced need for renal dialysis and other high-cost interventions, yielding lower total hospital charges. In this study we will test the hypothesis that, through a cost-free technical innovation, the quality of deceased donor kidneys could be improved significantly, saving thousands more lives per year and reducing total health care expenditures on renal transplantation.

Official Title
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Novel Strategies for Innovating Deceased Donor Procurement

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Procedure: Deceased donor nephrectomy, prior to cross clamp of donor aorta
* Procedure: Deceased donor nephrectomy, standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently listed to receive a deceased donor kidney transplant Able to fully understand the informed consent document Recipient over the age of 18 years Exclusion Criteria: Recipients undergoing a bilateral native nephrectomy at time of transplant Recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc) transplant Individuals who are unable to understand the informed consent document Recipient under age 18 years Recipients receiving desensitization protocols for high levels of donor specific antibodies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patients selected for this arm will receive the left kidney from the new method of organ retrieval. | Procedure: Deceased donor nephrectomy, prior to cross clamp of donor aorta<br>* The investigators will perform a prospective investigation of organ recoveries during which the left kidney will be removed prior to cessation of cardiac activity. The second kidney will be removed in the standard fashion. To do this, investigators will adopt techniques used in living donor kidney transplantation. Specifically, a specialized vascular stapler will be used to divide the renal artery at the level of aorta, followed by the vein, at the level of the vena cava. As such, no cuff of abdominal aorta or vena cava will be present on the target kidneys. Once removed from the body, just as is done for living donor kidney transplantation, the kidneys will be immediately flushed. As this ex-vivo flush is already performed for cadaveric kidney transplantation, there should be no additional cost for performing this portion of the procedure. Approximately 15 minutes of additional surgical dissection (prior to stopping the heart) will be required under the proposed study.<br>|
| Active Comparator: Arm 2<br>Patients selected for this arm will receive the normal standard of care operational kidney from retrieval. | Procedure: Deceased donor nephrectomy, standard of care<br>* The investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequence of organ procurement | Renal allograft survival | 1 year | 
| Kidney quality | Incidence of delayed renal graft function | 3 months |