NCT05194514

Trial to Compare the SherpaPak™ Device vs Cold Storage

Randomized Trial to Compare the SherpaPak™ Device vs Cold Storage of Donor Hearts in Transplantation: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Investigator's are doing this study to see which method of organ preservation leads to better outcomes for donated hearts. There are two methods of organ preservation. The first method is the use of cold storage. With this method, the donor heart is stored in preservation fluid within bags that are then placed on ice and transported in a cooler. This is the usual method for transporting donor hearts. This is also known as "standard of care." The second method is the use of the SherpaPak™ Cardiac Transport System. With this method, the donor heart is kept at a steady, consistent temperature throughout transportation. This method is not typically used for transporting donor hearts. The study will include up to 20 people in total.

Detailed description

This is a randomized study and has 2 study groups. Participants will be randomly assigned to a group in a 1:1 ratio. * 50% chance of receiving a donor heart using the SherpaPak™ method, or * 50% chance of receiving a donor heart using the cold storage method. The research team will analyze data from the medical records from the heart transplant and clinic visits up to 30 days after the heart transplant. Participants will be in the study for about 30 days.

Conditions

• Organ Transplant

Interventions

Type	Name	Description
DEVICE	SherpaPak™ Device	The SherpaPak™ Cardiac Transport System has been developed to provide a safe, consistent method for cold ischemic storage of donor hearts for transplantation. This device is FDA approved.
OTHER	Cold Storage	FDA-approved method for organ procurement

Timeline

• Start date: 2022-05-11
• Primary completion: 2023-08-31
• Completion: 2024-08-31
• First posted: 2022-01-18
• Last updated: 2025-02-21
• Results posted: 2025-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study