- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03007017
Novel Strategies for Innovating Deceased Donor Procurement
June 7, 2021 updated by: Joseph Scalea, University of Maryland, Baltimore
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Patients selected for this arm will receive the left kidney from the new method of organ retrieval.
|
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.
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Active Comparator: Arm 2
Patients selected for this arm will receive the normal standard of care operational kidney from retrieval.
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The investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sequence of organ procurement
Time Frame: 1 year
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Renal allograft survival
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1 year
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Kidney quality
Time Frame: 3 months
|
Incidence of delayed renal graft function
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
June 7, 2021
Study Completion (Actual)
June 7, 2021
Study Registration Dates
First Submitted
December 8, 2016
First Submitted That Met QC Criteria
December 28, 2016
First Posted (Estimate)
December 30, 2016
Study Record Updates
Last Update Posted (Actual)
June 9, 2021
Last Update Submitted That Met QC Criteria
June 7, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00071879
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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