Adjustable Temperature Cooler for Cold Static Storage of Donor Hearts for Transplantation
Cedars-Sinai Medical Center
Summary
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.
Description
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 medic…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Individuals 18 years old or older are included. * Individuals undergoing isolated heart transplantation are included. Exclusion Criteria: * Any records flagged "break the glass" or "research opt out." * Any patients undergoing multi-organ transplantation.
Interventions
- DeviceOrgan transport using SherpaPak
Paragonix SherpaPak
- DeviceRyobi cooler for Organ Transport
This is a temperature-controlled cooler without a gel or ice
Location
- Cedars Sinai Medical CenterLos Angeles, California