A Study of Experimental Blood Thinner "Dabigatran" for Treatment of Venous Thromboembolism in Children

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Healthy Volunteers:
VTE, dabigatran, Blood clots, venous thromboembolism, pediatric, coagulant, children, blood, thinner
Drug Study
3 Participants
The blood in veins may clot. The clots could break loose and circulate in the blood. The clotted blood could 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 rare. However, physicians must be able to handle it effectively when it does occur. The best treatment for venous thromboembolism in children is still being researched.

Current treatments for venous thromboembolism in children are called anticoagulants. These medications are also known as blood thinners and 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 blood clotting. Another requires that the medication be injected. The use of needles in these procedures may cause anxiety in children. This makes it difficult to ensure that they complete their treatment.

For these reasons the experimental medication “Dabigatran” has potential to overcome these issues. Dabigatran is the study drug that will be tested in this study. It is a blood thinner similar to the other venous thromboembolism treatments. It can be taken by mouth and does not require monitoring through blood tests.

This study will test the effectiveness of experimental medicine Dabigatran 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 complete.
Study duration and period
One Year
Recruitment period
From Aug. 18, 2016
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Joanna Consuelo Ramirez
Research Topic
  • Blood Clot Prevention