The blood in veins may clot. the clots could break loose and travel around in blood circulation. The clotted blood can block another blood vessel in a different area of the body. This can cause a variety of problems. This process is referred to as venous thromboembolim.
Venous thromboembolism in children is a rare event. However, physicians must be able to handle it effectively when it does occur. How to best treat venous thromboembolism in children is still being researched.
Current treatments for venous thromboembolism in children are called anticoagulants. These medications, otherwise known as blood thinners, make it more difficult for blood to clot.
The current standard treatment for venous thromboembolism in children presents some problems. One of the standard medications requires regular blood draws to test how the child's blood is clotting. Another requires that the medication be injected. The use of needles in these procedures can sometimes cause anxiety in children. This makes it difficult to ensure that they complete their treatment.
For these reasons the experimental medication “Dabigatran”, tested in this trial, has potential to overcome these issues. Dabigatran similar to the other venous thromboembolism treatments is a blood thinner. It can be taken by mouth and does not require monitoring through blood tests.
This study will test the effectiveness of Dabigatran as compared to the current standard treatments for venous thromboembolism.
This study requires
- There will be 12 planned visits to a study center
- You will be assigned by chance (like the flip of a coin) to receive either dabigatran or an acceptable standard of care medication.
- During the study, samples of your blood will be taken.
Who can participate?
Children up to 18 years of age with documented diagnosis of venous thromboembolism.
Benefits and risks of participating
Dabigatran is a blood thinner used to prevent undesired blood clotting. It will therefore take longer for you to stop bleeding if you are injured. Most of the side effects of the medication are related to bruising or bleeding. Full risks and potential benefits will be discussed with you during the consent process.
If you agree to be part of this study you will be paid $100.00 for each visit you completed.