Trial to Compare the SherpaPak™ Device vs Cold Storage

Cedars-Sinai Medical Center

Status: Completed

Conditions: Organ Transplant

Treatments: Other: Cold Storage; Device: SherpaPak™ Device

Study type: Interventional

Funder types: Other

Identifiers

NCT05194514

STUDY00001753

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any sex/gender, 18 years of age or older listed for primary heart transplant.
• Subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent OR consent of a legally authorized representative of a cognitively impaired individual will be obtained before the cognitively impaired individual may be included in research.
• Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
• Subjects must receive and accept a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies)

Exclusion criteria

• Re-do heart transplant
• Multi-organ transplant

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

SherpaPak™ Cardiac Transport System

Other group

Description:

When a matching donor heart from a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a subject identification number and randomized 1:1 to receive a heart transported using either standard of care cold storage or the SherpaPak™ Cardiac Transport System.

Treatment:

Device: SherpaPak™ Device

Cold Storage

Other group

Description:

When a matching donor heart from a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a subject identification number and randomized 1:1 to receive a heart transported using either standard of care cold storage or the SherpaPak™ Cardiac Transport System.

Treatment:

Other: Cold Storage