A prospective, open-label, non-randomized, multicentre trial to assess the safety and PD of Cangrelor as procedural platelet inhibitor in paediatric subjects from birth to <18 years of age undergoing diagnostic and/or therapeutic percutaneous vascular procedures for management of congenital heart disease
This research study is about a medicine named Cangrelor, also known as Kengrexal. It's for children of all ages, from newborns up to 18 years old, who are having special procedures on their hearts due to a heart condition they were born with (congenital heart disease). The main goal is to carefully watch for any side effects and to see how effectively Cangrelor works to stop blood clots during these procedures. Researchers will be looking at things like bleeding, breathing problems, changes in blood pressure, and other lab results to understand how safe and helpful this medicine is for young patients.
At a glance
What is this study about?
This study is investigating a medicine named Cangrelor, which is also known by its brand name, Kengrexal. It's designed for children and young people, from birth up to 18 years old, who have a "congenital heart disease" – this means they were born with a heart problem. These children are having special procedures on their blood vessels or heart, which might be to understand their condition better or to treat it.
The main aim of the study is to see how safe Cangrelor is when given during these heart procedures. Researchers will be keeping a very close eye on potential side effects, especially anything like bleeding, changes in breathing, or any other unexpected reactions. They also want to understand how the medicine works in children's bodies to prevent blood clots during these delicate procedures.
This kind of study is important because it helps doctors learn more about using medicines safely and effectively in younger patients, particularly for serious conditions like congenital heart disease. The information from this study will help ensure that children get the best possible care during their heart procedures.
Key takeaways
- This study is for children (newborns to age 18) with congenital heart disease.
- It tests a medicine called Cangrelor (Kengrexal) during heart procedures.
- The main goals are to check for safety and how well it prevents blood clots.
- Researchers will closely monitor for side effects like bleeding or breathing issues.
- Participation involves receiving the medicine and close medical checks, especially in the 72 hours after the procedure.
Who may be eligible?
To be considered for this study, patients must be children or young people with a heart condition they were born with (congenital heart disease). They must also be scheduled to have a specific type of heart procedure that involves going into their blood vessels, either to diagnose a problem or to treat it.
This study is open to patients of all ages, from newborns up to their 18th birthday, regardless of whether they are a boy or a girl. The medical team will check other specific health details to make sure it's safe and appropriate for a child to join the study.
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.
- Is your child under 18 years old?
- Does your child have a heart condition they were born with?
- Is your child scheduled for a heart procedure (either to find out more or for treatment)?
- Are you able to bring your child for follow-up checks after the procedure?
What does participation involve?
If your child takes part in this study, they will receive the study medicine, Cangrelor (Kengrexal), during their heart procedure. Throughout their time in the study, they will have regular medical checks, which might include blood tests, urine tests, and monitoring of their breathing, heart rate, and blood pressure. The doctors and nurses will closely watch for any side effects.
After the medicine is given, your child will be monitored for at least 72 hours to see how they react and to check for any bleeding or other issues. The full duration of your child's participation in the study will be explained by the study team, but it will involve careful monitoring during and shortly after their heart procedure.
Potential risks and benefits
Locations (3)
- —UnverifiedGermany
- —UnverifiedPortugal
- —UnverifiedAustria
Common questions
What is Cangrelor?
Cangrelor, also called Kengrexal, is a medicine used to help prevent blood clots, especially during medical procedures.
What is congenital heart disease?
Congenital heart disease means a child was born with a problem in how their heart was formed or how it works.
Will my child still get their usual treatment?
The study medicine is given during their planned heart procedure. The study team will explain how it fits with their overall care.
How long will my child be in the study?
Your child will be closely monitored during and for at least 72 hours after their heart procedure. The study team will give you the exact timeline.
What if we change our mind?
You are free to withdraw your child from the study at any time, for any reason, and it won't affect their medical care.
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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