Precise Cooler for Donor Heart Transport

Cedars-Sinai Medical Center

Status: Not yet enrolling

Conditions: Heart Transplantation

Treatments: Device: Ryobi cooler for Organ Transport; Device: Organ transport using SherpaPak

Study type: Interventional

Funder types: Other

Identifiers

NCT07354763

STUDY00004185 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Organ transport using Standard of Care Paragonix SherpaPak

Active Comparator group

Description:

In this arm, the organ will be transported using the FDA Approved Sheperpak by Paragonix

Treatment:

Device: Organ transport using SherpaPak

Organ transport using the RYOBI cooler.

Experimental group

Description:

In this arm, the organ will be transported using the Ryobi cooler

Treatment:

Device: Ryobi cooler for Organ Transport