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ACTIVE NOT RECRUITING
NCT06263023

A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation

Sponsor: 34 Lives, PBC

View on ClinicalTrials.gov

Summary

This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals.

Official title: An Observational Study of a Dedicated Preservation and Assessment Service to Optimize Organ Utilization for Hard-to-Place Kidneys

Key Details

Gender

All

Age Range

16 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2024-04-19

Completion Date

2028-03-25

Last Updated

2025-04-02

Healthy Volunteers

No

Interventions

OTHER

Sub-Normothermic Machine Preservation and Assessment

Human kidneys from HTP deceased donors will be transported to the Sponsor's central preservation and assessment facility and placed onto a machine perfusion system in a sterile operating room for a brief period of Sub-Normothermic Machine Perfusion (SNMP). Basic parameters including internal renal resistance, oxygen, and electrolyte levels will be recorded using standard point-of-care hospital analyzers. Accepted kidneys will be transported to a participating transplant center using a portable oxygenated LifePort Hypothermic Machine Preservation (HMP) device.

Locations (8)

Edward Hines, Jr. VA Hospital

Chicago, Illinois, United States

Indiana University Health

Indianapolis, Indiana, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Erie County Medical Center

Buffalo, New York, United States

New York University Langone

New York, New York, United States

The Mount Sinai Hospital

New York, New York, United States

Duke University

Durham, North Carolina, United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States