Novel Strategies for Innovating Deceased Donor Procurement

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Procedure: Deceased donor nephrectomy, prior to cross clamp of donor aorta; Procedure: Deceased donor nephrectomy, standard of care

• Registration Number: NCT03007017
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2016-12-30
• Study Start: 2017-01
• Status Verified: 2021-06
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-07
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Currently listed to receive a deceased donor kidney transplant
2. Able to fully understand the informed consent document
3. Recipient over the age of 18 years

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Exclusion Criteria

1. Recipients undergoing a bilateral native nephrectomy at time of transplant
2. Recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc) transplant
3. Individuals who are unable to understand the informed consent document
4. Recipient under age 18 years
5. Recipients receiving desensitization protocols for high levels of donor specific antibodies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Deceased donor nephrectomy, prior to cross clamp of donor aorta	Patients selected for this arm will receive the left kidney from the new method of organ retrieval.
Arm 2	Deceased donor nephrectomy, standard of care	Patients selected for this arm will receive the normal standard of care operational kidney from retrieval.

Primary Outcome Measures

Name	Time	Method
Sequence of organ procurement	1 year	Renal allograft survival
Kidney quality	3 months	Incidence of delayed renal graft function

Trial Locations

Locations (1)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States