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

NCT03837522 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Transplant
  • Renal Transplant

Interventions

DIAGNOSTIC_TEST

Procurement Biopsy: Frozen section

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.

DIAGNOSTIC_TEST

Procurement Biopsy: Permanent section

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.

Sponsors & Collaborators

  • Mid-America Transplant

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • St. Louis University

    lead OTHER

Principal Investigators

  • Krista Lentine, MD, PhD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2022-06-30
Completion
2023-02-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837522 on ClinicalTrials.gov