Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach
This study is for patients who have been on a life support machine called VA-ECMO due to severe heart and lung failure. This machine uses large tubes, called cannulas, placed in major blood vessels in the groin. When you no longer need ECMO, these tubes must be removed. This process, called decannulation, can sometimes lead to complications like bleeding or blood clots. Currently, doctors use surgery, manual pressure, or special closing tools to seal the artery. This study wants to find out if using a specific closing device is as safe and works as well as the standard methods for closing the artery after the ECMO tubes are taken out. This will help doctors understand the best way to do this procedure.
At a glance
What is this study about?
Imagine your heart and lungs need a temporary rest because they're very poorly. A special machine called VA-ECMO can help by doing their job for a while. To connect you to this machine, doctors gently place large tubes, called cannulas, into the important blood vessels in your groin area.
When you've recovered enough and no longer need the ECMO machine, these tubes need to come out. This process, known as 'decannulation', is very important, especially closing the artery where the tube was. Sometimes, there can be complications like bleeding or blood clots during this step.
Currently, doctors have a few ways to close the artery: they might perform a small surgery to sew it up, or press firmly on the area to stop the bleeding, or use special tools that help close the artery from the outside. Doctors aren't sure which of these methods is best for patients coming off ECMO. This study aims to find out if using one of these special tools is just as safe and effective as the other traditional methods for closing the artery after your ECMO tubes are removed.
Key takeaways
- The study compares methods for removing ECMO tubes.
- It checks if a special device is as safe as standard methods.
- Participation involves being randomly assigned to one of two tube removal methods.
- It aims to improve future care for ECMO patients.
- You can discuss it with your doctor and decide if it's right for you.
Who may be eligible?
This study is looking for adults aged 18 or older who have had their ECMO tubes placed in the main blood vessels in their groin area. The tubes must have been put in using a specific technique and placed in a certain part of the artery. Also, the size of your tubes needs to be a certain size to be suitable for the special closing device being tested.
You would not be able to join the study if you have severe hardening of the arteries, had your ECMO tubes put in through bigger open surgery, or if there's an infection around where your ECMO tube is. Also, if you're pregnant or breastfeeding, or already taking part in another medical study that involves an intervention, you wouldn't be able to participate.
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 18 years old or older?
- Did you have your ECMO tubes placed in your groin area?
- Did you have your ECMO tubes put in using a needle and wire (percutaneous)?
- Are you currently pregnant or breastfeeding?
- Do you have a severe infection where your ECMO tube is?
- Are you participating in another medical study that involves giving you a treatment?
What does participation involve?
If you decide to take part, you'll be randomly put into one of two groups. One group will have a special device used to close the artery after the ECMO tubes are removed. The other group will have the artery closed using the usual methods, which could be surgery or pressing on the artery, depending on what your doctor thinks is best for you. The study simply observes which method your doctor uses and how well it works. There are no extra visits or medications specifically for this study beyond your regular care. The total duration of your participation would be for the period relevant to the tube removal and immediate follow-up as part of your standard hospital stay.
Potential risks and benefits
Locations (2)
- Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and AngiologyVerified postcodeFrankfurt, Germany· Recruiting
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für KardiologieVerified postcodeMainz, Germany· Recruiting
Common questions
What is VA-ECMO?
VA-ECMO is a life support machine that helps your heart and lungs when they are too sick to work on their own, by taking over their job temporarily.
What are cannulas?
Cannulas are large, flexible tubes that are placed into your blood vessels, usually in your groin, to connect you to the ECMO machine.
What does 'decannulation' mean?
Decannulation is the process of safely removing these large ECMO tubes from your blood vessels once you no longer need the machine.
What is a 'vascular closure device'?
It's a special tool designed to help seal the hole in your artery after the ECMO tube is removed, usually through the skin without major surgery.
Why is this study important?
This study aims to find the safest and most effective way to close the artery after ECMO tube removal, which could improve outcomes for future patients.
How to find out more
Jelena Weller
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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