Heart Transplantation
Conditions
Keywords
Donor heart, Heart transplantation, organ procurement, heart failure
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.
Interventions
DEVICEOrgan transport using SherpaPak
Paragonix SherpaPak
DEVICERyobi cooler for Organ Transport
This is a temperature-controlled cooler without a gel or ice
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This study has two study groups. Organ transport using the RYOBI cooler and Organ transport using the Paragonix SherpaPak This means that you will be put in a study group by chance (like flipping a coin). You will be randomly put in one of the above study groups. You will have an equal chance of being placed in any one of the groups described above. A computer will randomly put you in a study group. We do this because no one knows if the results in one study group.
Eligibility
Sex/Gender
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of primary graft dysfunction | 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. |
Countries
United States
Contacts
CONTACTDominic Emerson, MD
Outcome results
None listed