Global Utilization And Registry Database for Improved heArt preservatioN
This study, called GUARDIAN, is collecting important information about heart transplants. Researchers want to see if using a special transport system, called SherpaPak CTS, helps keep donor hearts in better condition, leading to better results for patients. They will compare how patients recover and how well their new hearts work when transported with the SherpaPak CTS versus older methods. This involves gathering details about both the donor and the recipient, as well as the transplant procedure itself. The study will look at key health outcomes like survival rates, how well the new heart functions, and if patients need to go back to the hospital. The goal is to provide up-to-date information that could improve heart transplant care for many patients.
At a glance
What is this study about?
This study, called GUARDIAN, is all about improving heart transplants. When someone needs a heart transplant, the donor heart needs to be carefully transported from one place to another. Researchers are particularly interested in a newer system for carrying these hearts, called the SherpaPak Cardiac Transport System (CTS). They want to understand if using this system helps donor hearts stay healthier for longer, which could lead to better results for patients receiving a new heart.
To do this, the study will gather lots of information, like a detailed record. They'll look at patients who have already had heart transplants and also follow new patients moving forward. They will compare how well patients do when their new heart was transported using the SherpaPak CTS versus when older, standard methods were used. This includes checking things like how long patients live, how well their new heart works, and if they need further treatments or hospital stays.
Ultimately, by carefully looking at all this information, researchers hope to get a clearer picture of how different transport methods impact the success of heart transplants. This valuable data could help doctors make better decisions and improve the process for all patients needing a life-saving new heart.
Key takeaways
- This study evaluates a new system (SherpaPak CTS) for transporting donor hearts.
- It aims to find out if this improved transport leads to better patient outcomes after a heart transplant.
- Participation involves sharing medical information from your standard transplant care and follow-up.
- The study tracks patient progress for up to five years after their transplant.
- It covers both adult and child heart transplant recipients.
- There are no direct risks or changes to your medical treatment.
Who may be eligible?
This study is open to almost anyone who needs a heart transplant, including both adults and children, regardless of whether they are male or female. The main requirement is that you are scheduled to receive a primary (first) heart transplant. Your medical team will ensure that both the donor heart and your body are a good match and meet the standard medical requirements for a heart transplant at their hospital.
However, some people won't be able to join the study. This includes individuals who have already had an organ transplant in the past. Also, if there are specific concerns about whether the donor heart can be safely connected, or if you are currently in prison, you would not be able to participate. Your doctors will discuss all these points with you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you scheduled for a first heart transplant?
- Do you meet your hospital's standard requirements for a heart transplant?
- Have you not had a previous organ transplant?
- Are you not currently in prison?
What does participation involve?
If you participate in this study, you won't need to do anything extra beyond what’s already planned for your heart transplant care. The study is mainly about collecting information from your medical records, both from before your transplant and during your recovery. Your doctors and nurses will follow your progress after the transplant, just as they normally would. This includes checking in with you and doing standard medical tests at different times, like 24 hours after surgery, when you leave the hospital, and then at 30 days, 1 year, and even up to 5 years after your transplant. This information will help researchers understand how well you are doing over time. You won't be asked to take any study-specific medication or have additional appointments solely for the study.
Potential risks and benefits
Locations (22)
- Stanford UniversityVerified postcodeStanford, United States
- Medstar Washington HospitalVerified postcodeWashington D.C., United States
- University of Florida Health Shands HospitalVerified postcodeGainesville, United States
- Mayo ClinicVerified postcodeJacksonville, United States
- AdventHealth OrlandoVerified postcodeOrlando, United States
- Lutheran HospitalVerified postcodeFort Wayne, United States
- Kansas University Medical CenterVerified postcodeLawrence, United States
- Tufts University Medical CenterVerified postcodeBoston, United States
- Massachusetts General HospitalVerified postcodeBoston, United States
- Spectrum HealthVerified postcodeGrand Rapids, United States
- NewYork-Presbyterian Columbia University Irving Medical CenterVerified postcodeNew York, United States
- Duke UniversityVerified postcodeDurham, United States
Common questions
What is the main goal of this study?
The study aims to see if a special container called SherpaPak CTS helps donor hearts stay healthier, leading to better results for heart transplant patients.
Do I have to do anything extra if I join?
No, you won't need to do anything extra. The study just gathers information from your regular medical care and records after your heart transplant.
How long will they follow my health?
Researchers will look at your health information from your transplant up to five years afterwards, as part of your standard follow-up care.
Can children join this study?
Yes, both adults and children who are having a first heart transplant can be part of this study, as long as they meet other medical criteria.
What happens if I change my mind about being in the study?
You can choose to stop participating in the study at any time, and it will not affect the medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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