Novel Strategies for Innovating Deceased Donor Procurement

NCT03007017 | Completed DMC

• 1 other identifier: 00071879
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (2)

• Sequence of organ procurement

  Renal allograft survival

  1 year

• Kidney quality

  Incidence of delayed renal graft function

  3 months

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

ACTIVE COMPARATOR

Patients selected for this arm will receive the normal standard of care operational kidney from retrieval.

Procedure: Deceased donor nephrectomy, standard of care

Interventions

Deceased donor nephrectomy, prior to cross clamp of donor aorta PROCEDURE

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.

Arm 1

Deceased donor nephrectomy, standard of care PROCEDURE

The investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Living Legacy Foundation: collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery Director of Pancreas and Islet Cell Transplantation

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 30, 2016
• Study Start: January 1, 2017
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)