Cooling Methods for Heart Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare two methods for keeping donor hearts cold during transport. One group will use the FDA-approved Paragonix SherpaPak, while the other will test an adjustable temperature Ryobi cooler. The trial will determine if the Ryobi cooler can precisely control temperature, reduce waste, and save money. Individuals 18 or older undergoing a heart transplant (excluding multiple organ transplants) may qualify for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance heart transplant procedures and outcomes.
Do I need to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that these cooling methods are safe for heart transplant transportation?
Research has shown that the RYOBI cooler, used for transporting donor hearts, maintains the optimal temperature, which is crucial for preserving heart health during transport. The RYOBI cooler may also be more environmentally friendly and cost-effective compared to the Paragonix SherpaPak, which the FDA has approved and is widely used.
The RYOBI cooler operates like traditional methods that have safely transported hearts for many years. While the SherpaPak uses advanced technology to maintain heart condition, the RYOBI cooler emphasizes precise temperature control. Although specific safety data on the RYOBI cooler is not yet available, its testing against an FDA-approved method suggests it is considered safe enough for broader evaluation.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative cooling methods for transporting hearts during transplants. Unlike the standard Paragonix SherpaPak, which is already FDA-approved for organ transport, the Ryobi cooler is being tested as a novel, potentially cost-effective alternative. This trial aims to determine if the Ryobi cooler can maintain the organ's temperature effectively, possibly enhancing the preservation time and availability of organs for transplant. If successful, this could streamline transplant logistics and make heart transplants more accessible and efficient.
What evidence suggests that these cooling methods are effective for heart transplant transportation?
Research has shown that maintaining donor hearts at approximately 8 degrees Celsius (46 degrees Fahrenheit) can yield better results than storing them at colder temperatures. This trial tests the RYOBI cooler as an experimental method against the FDA-approved Paragonix SherpaPak device, the current standard of care. The RYOBI cooler maintains this specific temperature and may improve heart transplant success rates by preserving the heart's condition during transport. Although the SherpaPak is the standard, the RYOBI cooler could offer a promising alternative for heart preservation.12367
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Organ Transport
Donor hearts are randomized to be transported using either the RYOBI cooler or the Paragonix SherpaPak
Post-Transplant Monitoring
Participants' medical records are reviewed for medications used, diagnostic studies, and medical history
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
In this arm, the organ will be transported using the Ryobi cooler
In this arm, the organ will be transported using the FDA Approved Sheperpak by Paragonix
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor
Citations
Outcomes in Heart Transplant Recipients by Bridge to ...
Abstract. The last several years have seen a rise in use of mechanical circulatory support (MCS) to bridge heart transplant recipients.
Giving hearts, and patients, longer lives with advanced ...
The XVIVO Heart Assist Transport cold perfusion technology received an FDA investigatory device exemption in 2023 for hearts from extended ...
Cooling Methods for Heart Transplant · Info for Participants
The study compares two methods of transporting donor hearts: a commercially available device called SherpaPak and a RYOBI cooler that allows for precise ...
4.
trial.medpath.com
trial.medpath.com/clinical-trial/15275249f0d696a0/nct07354763-adjustable-temperature-cooler-cold-static-storage-donor-hearts-transplantationPrecise Cooler for Donor Heart Transport | MedPath
The purpose of this study is to compare outcomes following heart transplant using two different storage devices for transport of the donor heart ...
'Heart in a box' technology expands transplant capabilities
The heart is maintained at 8 degrees Celsius (about 46 degrees Fahrenheit), which has shown to have better outcomes than transport at colder ...
Surbhi Dadwal's research works
There are different heart transport methods, including the traditional static methods of Cooler and Ryobi and advanced dynamic methods, including SherpaPak and ...
7.
wsaw.com
wsaw.com/2024/04/10/groundbreaking-research-out-about-technology-preserve-organs-after-donations/Groundbreaking research out about technology to preserve ...
Doctors at Mayo Clinic say the new system has the potential to widen the donor pool and potentially revive non-beating hearts for transplant.
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