Differences in coagulation between fresh frozen plasma and Solvent-detergent plasma in pediatric congenital heart surgery
Doctors are studying two types of plasma, fresh frozen plasma (FFP) and Omniplasma, to see which one works best to help blood clot properly after heart surgery in children. When children have surgery, especially on their heart, their blood's ability to clot can be affected. Plasma is the liquid part of blood and contains important proteins that help with clotting. This study will compare how these two plasma types affect clotting factors like specific proteins and how quickly blood clots, measured right after surgery. The goal is to find out if one type of plasma is safer or more effective for children. This is a crucial step to improve care for young patients undergoing complex heart operations.
At a glance
What is this study about?
When children have heart operations, it's really important that their blood can clot properly afterwards to prevent too much bleeding. Sometimes, medical teams use blood products like plasma to help with this. Plasma is the clear, yellowish liquid part of blood that carries cells and contains many important proteins, including those that help stop bleeding.
This study is comparing two different types of plasma: 'fresh frozen plasma' (often called FFP) and a newer type called 'Omniplasma'. Both are used to help blood clot, but doctors want to understand if one works better or has different effects on children's blood after surgery. They will measure various things in the blood, such as levels of proteins involved in clotting and how quickly the blood clots, right after the operation.
The main aim is to see if there are any important differences between FFP and Omniplasma in how they affect a child's ability to clot blood after heart surgery. Finding the best and safest way to manage blood clotting during and after these critical operations is vital to help children recover well. This type of research, known as a Phase III study, helps confirm the best treatments.
Key takeaways
- This study compares two types of plasma used after children's heart surgery.
- It aims to find out which plasma (FFP or Omniplasma) helps blood clot better.
- Participation involves receiving one of these plasma types and having extra blood tests.
- The findings will help improve care for children having heart operations.
- You can withdraw your child from the study at any time.
Who may be eligible?
This study is for children who are going to have heart surgery and who might need plasma to help their blood clot properly. Doctors will decide which children are suitable to take part, based on their medical condition and the type of surgery they are having.
There are no specific age limits; children of all ages, from babies to teenagers, might be able to join if their doctors think it's right for them. Also, the study is open to both boys and girls.
Even though there are no strict age or sex limits, children will only be included if their medical team believes it's appropriate for their care and if their parents or guardians agree after understanding everything about the study.
- Is my child having heart surgery?
- Does their medical team think plasma might be needed after surgery?
- Am I comfortable with my child potentially receiving either FFP or Omniplasma?
- Am I happy for some extra blood samples to be taken as part of their care?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If your child is eligible and you agree for them to take part, the study will involve them receiving either fresh frozen plasma (FFP) or Omniplasma during or soon after their heart surgery. This is part of the treatment they would already be receiving to help their blood clot.
There won't be extra visits just for this study. The medical team will simply collect extra small blood samples at specific times, usually right after surgery, that are already planned as part of their routine care. These samples will be tested to measure how their blood is clotting. The medication they receive, whether FFP or Omniplasma, will be given as a drip, similar to how blood products are usually given. The researchers will be looking at what happens during their hospital stay and won't require follow-up visits specifically for the study after they leave the hospital.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is plasma?
Plasma is the liquid part of your blood that carries blood cells and contains proteins that help your blood clot and fight infections.
Why do children need plasma after heart surgery?
After complex heart surgery, a child's blood might not clot as easily as it should. Plasma can help by providing important clotting proteins.
What is the difference between FFP and Omniplasma?
Both are types of plasma used to help blood clot. This study aims to find out if one has different or better effects than the other after surgery.
Will taking part change my child's surgery?
No, your child will still have their planned heart surgery. This study looks at a part of their post-surgery care that involves blood clotting.
Will my child have extra tests?
They may have a few extra small blood samples taken, usually at the same time as routine blood tests, to measure specific clotting factors.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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