Novel Strategies for Innovating Deceased Donor Procurement

NCT ID: NCT03007017

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2021-06-07

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm 1

Patients selected for this arm will receive the left kidney from the new method of organ retrieval.

Group Type: EXPERIMENTAL

Deceased donor nephrectomy, prior to cross clamp of donor aorta

Intervention Type: 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 2

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

Group Type: ACTIVE_COMPARATOR

Deceased donor nephrectomy, standard of care

Intervention Type: PROCEDURE

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

Interventions

Deceased donor nephrectomy, prior to cross clamp of donor aorta

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.

Intervention Type: PROCEDURE

Deceased donor nephrectomy, standard of care

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Living Legacy Foundation

UNKNOWN

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Joseph Scalea

Assistant Professor of Surgery Director of Pancreas and Islet Cell Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

00071879

Identifier Type: -

Identifier Source: org_study_id