Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies

Study Overview
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Brief Summary
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The purpose of this research study is to compare the impact of the availability of biopsy results at the time of organ offers on the use and outcomes of kidneys from deceased donors.

Detailed Description
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Randomization of biopsy processing will be performed at the level of the deceased donor. If the participant agrees to be in this study and signs the informed consent, at the time that a kidney is accepted for them, the accepted deceased donor will be randomized, like a flip of a coin, to one of two groups. Group 1: biopsies will be processed immediately (routine frozen section) and results will be available to clinical teams at the time of the organ offers. Frozen section refers to a process where tissue from the biopsy sample is prepared by freezing and then slicing the tissue sample. Importantly, it can be done in about 15 to 20 minutes. Frozen sections are done when an immediate answer is needed; however, the quality of the sample is not always optimal. Group 2: biopsies will be processed using permanent sections - these results will not be available until after the organ is transplanted. Permanent section refers to a process where tissue from the biopsy sample is prepared by placing the tissue sample in a fixative, called formalin, to preserve the tissue, processing it through other additional solutions, and then placing it in paraffin wax. After the wax hardens, the tissue is cut into very thin slices, which are placed on slides and stained. This process normally takes several days. There is a 50/50 chance that the donor will be randomized to immediate biopsy processing by frozen section, versus permanent processing that yields results after transplant. If for any reason their surgeon feels that it would not be safe to proceed without the biopsy result, he or she will have the ability to receive the results of the biopsy before the transplant. The study team will record any episodes of this occurrence.

Official Title
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Pilot Randomized Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies

Conditions
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Kidney Transplant, Renal Transplant

Intervention / Treatment
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* Diagnostic Test: Procurement Biopsy: Frozen section
* Diagnostic Test: Procurement Biopsy: Permanent section


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney transplant candidate On waitlist for kidney transplant at the time of informed consent at one of the participating sites Age 18 or older Willing and able to provide informed consent for participation in the study Exclusion Criteria: Unable or unwilling to provide informed consent to participate in the study Younger than 18 years old Not on waitlist for kidney transplant at the time of informed consent at one of the participating centers Candidates for or recipients of multi-organ transplants (kidney along with another solid organ)

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Procurement Biopsy: Frozen section<br>In the routine care condition, biopsies will be processed immediately as a frozen section. | Diagnostic Test: Procurement Biopsy: Frozen section<br>* Frozen sections are prepared by freezing and slicing the tissue sample; importantly, they can be done in about 15 to 20 minutes. Frozen sections are done when an immediate answer is needed, but do not provide optimal quality.<br>* Other names: Immediate results;|
| Active Comparator: Procurement Biopsy: Permanent section<br>In the intervention group, the biopsy processing will be delayed to permanent section, and therefore not available until allocation is complete. | Diagnostic Test: Procurement Biopsy: Permanent section<br>* Permanent sections are prepared by placing the tissue in fixative (usually formalin) to preserve the tissue, processing it through additional solutions, and then placing it in paraffin wax. After the wax has hardened, the tissue is cut into very thin slices, which are placed on slides and stained. The process normally takes several days.<br>* Other names: Delayed results;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk-adjusted kidney yield | per kidney donor with an immediate vs delayed procurement biopsy processing (this will serve as the primary organ utilization metric, and is the adjusted converse of organ discard) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life years for transplant recipients | Life years or survival for candidates after offer of kidney with an immediate vs delayed procurement biopsy processing | 3 years | 
| Number of participants with delayed graft function | Number of participants with delayed graft function after transplant of kidney with an immediate vs delayed procurement biopsy processing | 3 years | 
| Number of participants with graft survival | Number of participants with graft survival after transplant of kidney with an immediate vs delayed procurement biopsy processing | 3 years | 
| Cold ischemia time | Cold ischemia time for kidneys transplanted after immediate vs delayed procurement biopsy processing | 3 years | 
| Patient survival after transplant | Patient survival after transplant of kidney with an immediate vs delayed procurement biopsy processing | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biopsy, Deceased kidney donation, Kidney transplantation