Cooling Methods for Heart Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
We are doing this study to compare approaches to cold storage of donor hearts during transportation. The adjustable temperature RYOBI cooler should allow precise temperature control while reducing environmental waste and providing a cost savings benefit when compared to the commercially available, FDA-approved Paragonix SherpaPak device.
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who are undergoing an isolated heart transplant. It's designed to find the best way to keep donor hearts cold during transport.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Organ Transport
Donor hearts are randomized to be transported using either the RYOBI cooler or the Paragonix SherpaPak
Post-Transplant Monitoring
Participants' medical records are reviewed for medications used, diagnostic studies, and medical history
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ryobi Cooler
- SherpaPak
Trial Overview
The study compares two methods of transporting donor hearts: a commercially available device called SherpaPak and a RYOBI cooler that allows for precise temperature adjustments, which may be more cost-effective and environmentally friendly.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
In this arm, the organ will be transported using the Ryobi cooler
In this arm, the organ will be transported using the FDA Approved Sheperpak by Paragonix
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor
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