Adjustable Temperature Cooler for Cold Static Storage of Donor Hearts for Transplantation
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Incidence of primary graft dysfunction
Overview
Brief 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.
Detailed 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts 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.
Arms & Interventions
Organ transport using Standard of Care Paragonix SherpaPak
In this arm, the organ will be transported using the FDA Approved Sheperpak by Paragonix
Intervention: Organ transport using SherpaPak (Device)
Organ transport using the RYOBI cooler.
In this arm, the organ will be transported using the Ryobi cooler
Intervention: Ryobi cooler for Organ Transport (Device)
Outcomes
Primary Outcomes
Incidence of primary graft dysfunction
Time Frame: From Randomization to 30 days after heart transplantation
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dominic Emerson, MD
Associate Surgical Director of Heart Transplant and Mechanical Circulatory Support, Director of Robotic Cardiac Surgery, and Director of the Accreditation Council for Graduate Medical Education Fellowship Program
Cedars-Sinai Medical Center