An investigation of clinical outcomes and inflammatory response to heparin free extracorporeal membrane oxygenation support during clinical lung transplantation – a prospective double-blind randomised feasibility study. “Zero-Hep”
The "Zero-Hep" study is a research project designed to investigate a different approach to providing vital life support during lung transplant surgery. This support system is called ECMO, which stands for Extracorporeal Membrane Oxygenation. Normally, a blood-thinning medicine called heparin is used with ECMO to prevent blood clots. However, this study is exploring what happens when ECMO is used without heparin. Researchers want to find out if using ECMO without heparin might lead to fewer problems like blood clots in the arteries or veins, or blockages in the ECMO machine itself. They are also looking at potential side effects like serious bleeding and the survival rate in the hospital. This study is for adults aged 18 and over, of any gender, who are undergoing a lung transplant.
At a glance
What is this study about?
Imagine your body needs extra help with its breathing and heart function, especially during a big surgery like a lung transplant. This is where a special machine called ECMO comes in. It acts like an artificial lung and heart outside your body, giving you the support you need. Usually, when doctors use ECMO, they also give patients a medicine called heparin. Heparin is a 'blood thinner' that helps stop blood clots from forming inside the ECMO machine or in your body, which can be an important concern when blood is flowing outside the body.
However, while heparin is good at preventing clots, it can also increase the risk of bleeding. This study, called "Zero-Hep," is looking into whether using ECMO *without* heparin could be a safer option for people having lung transplants. The main things the researchers want to find out are if not using heparin leads to fewer blood clots in the patient's body or in the ECMO machine itself. They are also keeping a close eye on other important things, such as serious bleeding and how well patients recover after surgery.
This kind of study, called a "feasibility study," helps doctors understand if a new treatment or method is safe and practical to use for a larger group of patients in the future. It's a careful step to see if changing the way ECMO is used during lung transplants could potentially improve patient care and reduce complications.
Key takeaways
- The study is called "Zero-Hep" and focuses on lung transplant patients.
- It's about a life support system called ECMO, comparing it with and without a blood thinner (heparin).
- Researchers are looking for problems like blood clots or serious bleeding.
- This is a feasibility study to see if a new approach is safe and practical.
- Participants must be 18 or older and undergoing a lung transplant.
- You won't know if you're receiving heparin or a different solution during the study.
Who may be eligible?
This study is particularly looking for adults who are scheduled to have a lung transplant. To be considered for the study, you need to be at least 18 years old – there's no upper age limit. Your gender doesn't matter; both men and women can take part.
This study is specifically about patients undergoing a lung transplant and receiving ECMO support. It's important to remember that this study isn't open to everyone; it's focused on this specific group of patients.
If you are facing a lung transplant, your medical team would be the best people to tell you if this study might be suitable for you.
- Are you 18 years old or older?
- Are you scheduled to have a lung transplant?
- Are you comfortable with the idea of receiving ECMO support?
- Are you happy to be monitored closely during your hospital stay?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you are invited to take part in this study, it would happen as part of your lung transplant process. You wouldn't need extra visits just for the study beyond your usual medical care. The study involves giving you either a standard salt water solution or the usual blood-thinning medicine (heparin) alongside your ECMO treatment, but you wouldn't know which one you're receiving – this is decided by chance, like flipping a coin. Doctors would closely monitor your health, looking for any signs of blood clots or bleeding, and observing how you recover while in the hospital. The total duration of your participation would be until you are discharged from the hospital.
Potential risks and benefits
Locations (1)
- —Austria
Common questions
What is ECMO?
ECMO is a machine that does the job of your heart and lungs outside your body, giving your organs a chance to rest and heal.
What is heparin?
Heparin is a medication used to thin your blood and help prevent blood clots from forming.
Why are doctors looking at not using heparin?
While heparin prevents clots, it can also increase the risk of bleeding, so doctors are exploring if ECMO without heparin is a safe option.
Will I know if I'm getting heparin or not?
No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you're receiving heparin or a salt water solution.
How long would I be in the study?
Your participation would last until you are discharged from the hospital after your lung transplant.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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