Precise Cooler for Donor Heart Transport
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Organ transport using SherpaPak, Ryobi cooler for Organ Transport.
- Who it may be relevant to
- Registry conditions: Heart Transplantation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adjustable Temperature Cooler for Cold Static Storage of Donor Hearts for Transplantation
Overview
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
- Device Organ transport using SherpaPak
Paragonix SherpaPak - Device Ryobi cooler for Organ Transport
This is a temperature-controlled cooler without a gel or ice
Primary outcome measures
- Incidence of primary graft dysfunction [Time frame: From Randomization to 30 days after heart transplantation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Cedars Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT07354763 · STUDY00004185