An interventional study of Organ transport using SherpaPak and Ryobi cooler for Organ Transport in Heart Transplantation, sponsored by Cedars-Sinai Medical Center. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Other
The investigators 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.
The purpose of this study is to compare outcomes following heart transplant using two different storage devices for transport of the donor heart, an adjustable temperature cooler or a commercially available storage device called the Paragonix SherpaPak.
When a donor heart is identified for transplant, the method of storage during transportation will be randomized to one of two different options for cold storage. All other parts of the participant's care will then continue per usual standard of care. In the thirty days following transplant, the research team will review the participant's medical record to see what medications were used after transplant, what diagnostic studies like echocardiograms showed, and to collect basic information about the participant's medical history.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 80 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In this arm, the organ will be transported using the FDA Approved Sheperpak by Paragonix
Device: Organ transport using SherpaPak
In this arm, the organ will be transported using the Ryobi cooler
Device: Ryobi cooler for Organ Transport
Paragonix SherpaPak
This is a temperature-controlled cooler without a gel or ice
Incidence of primary graft dysfunction
compare the incidence of primary graft dysfunction between patients randomized to donor heart preservation using the adjustable temperature RYOBI cooler (Model # Pi1824QBT) (n = 40) versus the Paragonix SherpaPak (n = 40) in cases where the anticipated total ischemic time for the graft is between 120 and 240 minutes.
Time frame: From Randomization to 30 days after heart transplantation
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center