RecruitingNot ApplicableNCT06877169

Staged Kidney Transplantation During Combined Heart/Kidney Transplantation


Sponsor

Cedars-Sinai Medical Center

Enrollment

20 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study is to evaluate the safety and efficacy of ex vivo machine perfusion with staged implantation of kidney allografts during combined heart/kidney transplantation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining a staged surgical approach to combined heart and kidney transplantation — where the kidney transplant is performed in a separate procedure shortly after the heart transplant, rather than both organs being transplanted simultaneously. The goal is to understand whether this staged strategy leads to better kidney outcomes for patients who need both organs. **You may be eligible if...** - You are 18 or older - You are undergoing a combined heart and kidney transplant at Cedars-Sinai Medical Center in a staged (separate) surgical approach **You may NOT be eligible if...** - Your medical condition required that both the heart and kidney be transplanted during a single simultaneous operation - Your medical record is flagged as "break-the-glass" or "research opt-out" in the hospital's electronic health record system Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPlanned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation.

During combined heart and kidney transplantation, heart and kidney allografts may be implanted during a single operative event, or with delayed kidney implantation in a second operative event. Timing of the delay is often determined by recipient stability and kidney availability; however, clinicians must balance recipient factors with accumulating cold ischemic time of the kidney allograft. This study uses hypothermic oxygenated machine perfusion to reduce ischemic injury to the kidney allograft and allow for improved recipient stability with planned delayed implantation of the kidney graft. Delays will allow for at least 6 hours of hypothermic oxygenated machine perfusion prior to implantation.


Locations(1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

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NCT06877169


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