Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
United States20 participantsStarted 2025-04-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (18 years or older) undergoing combined heart and kidney transplantation at Cedars-Sinai Medical Center.
Exclusion Criteria:
* Patients who undergo simultaneous heart/kidney transplantation in a single operative event due to medical necessity will be excluded.
* Patients with medical records flagged as "break-the-glass" or "research opt-out" within the center's electronic health record.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves transplanting the heart first and then the kidney in a staged approach during the same surgery — how does that sequence differ from how combined heart and kidney transplants are typically done, and what does my doctor think the potential benefit or risk of that staged timing might be for someone in my situation?
2Since this trial is listed as 'Phase NA,' meaning it's not a standard drug trial with defined safety phases, what is actually known so far about the safety of this staged transplant approach, and how does that affect what my care team can tell me about expected risks?
3The trial is specifically measuring 'delayed graft function' in the kidney — can my doctor explain what delayed graft function means, how likely it might be for me, and what the consequences would be if my transplanted kidney didn't start working right away?
4Given that I have both heart failure and chronic kidney disease, how would my doctor weigh the option of joining this trial against getting a standard combined heart-kidney transplant outside of this study?
5This trial is actively recruiting, so it's still enrolling patients — does my doctor think my current health status, kidney function, and heart condition would make me a reasonable candidate to even discuss with the transplant team running this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of delayed graft function (DGF) of the kidney allograft
Timeframe: 7 days
2
Number of patients with at least one adverse event