Report from a consensus conference on primary graft dysfunction after cardiac transplantation.
Jon Kobashigawa, Andreas Zuckermann, Peter Macdonald...
https://pubmed.ncbi.nlm.nih.gov/24661451Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06877169
Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
Led by Cedars-Sinai Medical Center · Updated on 2025-06-03
20
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the safety and effectiveness of a new method for preserving and implanting kidney transplants during combined heart and kidney transplantation. It focuses on patients who have both heart failure and chronic or end-stage kidney disease and face challenges because the heart and kidney transplants require complex surgical coordination and careful management of patient stability. Participants will receive a heart transplant followed by a delayed kidney transplant. The kidney graft will be preserved using hypothermic oxygenated machine perfusion (HOPE), which adds oxygen during preservation to reduce injury to the kidney. The timing of kidney implantation depends on the recipient's stability and will allow at least 6 hours of HOPE preservation before transplantation. During the study, participants will undergo standard transplant procedures with monitoring of their health and graft function. Researchers will assess delayed graft function of the kidney within 7 days and track adverse events up to 90 days. Additional follow-up will measure heart and kidney graft function, length of hospital stays, readmissions, and rejection rates up to 36 months. The total study duration extends to February 2035 to capture long-term outcomes.
CONDITIONS
Brief Title
Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years or older) undergoing combined heart and kidney transplantation at Cedars-Sinai Medical Center.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to several days depending on recipient stability and timing of kidney implantation
Participants undergo heart transplantation followed by planned delayed kidney transplantation with hypothermic oxygenated machine perfusion (HOPE) used to preserve the kidney allograft for at least 6 hours before implantation. Timing of kidney implantation depends on participant stability and routine care techniques are followed for both transplant procedures.
1 to 2 operative events
Follow-up
Duration - Up to 36 months
Participants are monitored for kidney and heart graft function, adverse events, length of hospital and intensive care stays, and readmissions over several months up to 3 years after transplantation.
Multiple visits during the first year and periodic assessments up to 36 months
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
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Research Team
J
Justin A Steggerda, M.D.
N
Noriko Ammerman, Pharm.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Oxygenated versus standard cold perfusion preservation in kidney transplantation (COMPARE): a randomised, double-blind, paired, phase 3 trial.
Ina Jochmans, Aukje Brat, Lucy Davies...
https://pubmed.ncbi.nlm.nih.gov/33220737Simultaneous Heart-kidney Transplant With Planned Delayed Implantation of the Kidney Graft After Ex Vivo Perfusion.
Andrew J Lutz, Santosh Nagaraju, Asif A Sharfuddin...
https://pubmed.ncbi.nlm.nih.gov/37271866Combined heart and kidney transplantation: what is the appropriate surgical sequence?
Andrea Ruzza, Lawrence S C Czer, Alfredo Trento...
https://pubmed.ncbi.nlm.nih.gov/23615433