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| Name | Class |
|---|---|
| Mid-America Transplant | OTHER |
| Washington University School of Medicine | OTHER |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procurement Biopsy: Frozen section | Active Comparator | In the routine care condition, biopsies will be processed immediately as a frozen section. |
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| Procurement Biopsy: Permanent section | Active Comparator | In the intervention group, the biopsy processing will be delayed to permanent section, and therefore not available until allocation is complete. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procurement Biopsy: Frozen section | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krista Lentine, MD, PhD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis University | St Louis | Missouri | 63110 | United States | ||
| Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30345720 | Background | Cooper M, Formica R, Friedewald J, Hirose R, O'Connor K, Mohan S, Schold J, Axelrod D, Pastan S. Report of National Kidney Foundation Consensus Conference to Decrease Kidney Discards. Clin Transplant. 2019 Jan;33(1):e13419. doi: 10.1111/ctr.13419. Epub 2018 Oct 21. | |
| 25772854 | Background | Wang CJ, Wetmore JB, Crary GS, Kasiske BL. The Donor Kidney Biopsy and Its Implications in Predicting Graft Outcomes: A Systematic Review. Am J Transplant. 2015 Jul;15(7):1903-14. doi: 10.1111/ajt.13213. Epub 2015 Mar 13. |
| Label | URL |
|---|---|
| National Kidney Foundation. Progress: Discarding a kidney can discard a life. Overview of Consensus Conference to Decrease Kidney Discards. | View source |
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|
| Procurement Biopsy: Permanent section | Diagnostic Test | 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. |
|
|
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 |
| St Louis |
| Missouri |
| 63110 |
| United States |
| 26599490 | Background | Naesens M. Zero-Time Renal Transplant Biopsies: A Comprehensive Review. Transplantation. 2016 Jul;100(7):1425-39. doi: 10.1097/TP.0000000000001018. |
| 28052609 | Background | Hart A, Smith JM, Skeans MA, Gustafson SK, Stewart DE, Cherikh WS, Wainright JL, Kucheryavaya A, Woodbury M, Snyder JJ, Kasiske BL, Israni AK. OPTN/SRTR 2015 Annual Data Report: Kidney. Am J Transplant. 2017 Jan;17 Suppl 1(Suppl 1):21-116. doi: 10.1111/ajt.14124. |
| 23949799 | Background | De Vusser K, Lerut E, Kuypers D, Vanrenterghem Y, Jochmans I, Monbaliu D, Pirenne J, Naesens M. The predictive value of kidney allograft baseline biopsies for long-term graft survival. J Am Soc Nephrol. 2013 Nov;24(11):1913-23. doi: 10.1681/ASN.2012111081. Epub 2013 Aug 15. |
| 24558053 | Background | Kasiske BL, Stewart DE, Bista BR, Salkowski N, Snyder JJ, Israni AK, Crary GS, Rosendale JD, Matas AJ, Delmonico FL. The role of procurement biopsies in acceptance decisions for kidneys retrieved for transplant. Clin J Am Soc Nephrol. 2014 Mar;9(3):562-71. doi: 10.2215/CJN.07610713. Epub 2014 Feb 20. |
| 29217537 | Background | Husain SA, Chiles MC, Lee S, Pastan SO, Patzer RE, Tanriover B, Ratner LE, Mohan S. Characteristics and Performance of Unilateral Kidney Transplants from Deceased Donors. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):118-127. doi: 10.2215/CJN.06550617. Epub 2017 Dec 7. |
| 29292608 | Background | Hart A, Smith JM, Skeans MA, Gustafson SK, Wilk AR, Robinson A, Wainright JL, Haynes CR, Snyder JJ, Kasiske BL, Israni AK. OPTN/SRTR 2016 Annual Data Report: Kidney. Am J Transplant. 2018 Jan;18 Suppl 1(Suppl 1):18-113. doi: 10.1111/ajt.14557. |
| 15272280 | Background | Walker PD, Cavallo T, Bonsib SM; Ad Hoc Committee on Renal Biopsy Guidelines of the Renal Pathology Society. Practice guidelines for the renal biopsy. Mod Pathol. 2004 Dec;17(12):1555-63. doi: 10.1038/modpathol.3800239. |
| 34045315 | Derived | Lentine KL, Kasiske B, Axelrod DA. Procurement Biopsies in Kidney Transplantation: More Information May Not Lead to Better Decisions. J Am Soc Nephrol. 2021 Aug;32(8):1835-1837. doi: 10.1681/ASN.2021030403. Epub 2021 May 27. No abstract available. |
| Eurotransplant Statistics Report Library. | View source |