Cooling Methods for Heart Transplant

DE
Overseen ByDominic Emerson, MD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

We 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.

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are undergoing an isolated heart transplant. It's designed to find the best way to keep donor hearts cold during transport.

Inclusion Criteria

I am having a heart transplant only.
I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Organ Transport

Donor hearts are randomized to be transported using either the RYOBI cooler or the Paragonix SherpaPak

Immediate upon donor heart identification

Post-Transplant Monitoring

Participants' medical records are reviewed for medications used, diagnostic studies, and medical history

30 days
Regular follow-up visits as per standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ryobi Cooler
  • SherpaPak

Trial Overview

The study compares two methods of transporting donor hearts: a commercially available device called SherpaPak and a RYOBI cooler that allows for precise temperature adjustments, which may be more cost-effective and environmentally friendly.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Organ transport using the RYOBI cooler.Experimental Treatment1 Intervention
Group II: Organ transport using Standard of Care Paragonix SherpaPakActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+