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The purpose of this multi-center research study is to test the investigational drug dabigatran etexilate in pediatric patients who have venous thromboembolism (VTE), a blood clotting disorder, and to compare their results to participants using either a vitamin K antagonist (VKA) or low-molecular-weight heparin (LMWH), both of which are approved prescription medications used to treat blood clots. The study drug, which has been approved for use in adults, is a blood thinner that may help to prevent VTE.
This study is accepting patients of both genders, through age 17, diagnosed with a VTE that requires treatment with anticoagulants (blood thinners) for a period of at least 3 months.
Males and Females: Through age 17
The study begins with a screening visit that includes a physical exam and various medical tests. Participants will be provided either the study drug (dabigatran) or will be prescribed an alternative standard medication (either VKA or LMWH). Return visits for exams and testing will be scheduled, and parents/caregiviers will need to keep a journal tracking the child’s drug intake over the study duration.
Visits: About 9
Duration: Approximately 4 months
Boehringer Ingelheim Pharmaceuticals
Study Description at National Institutes of Health
Cancer and Blood Disorder Research
James D. Cooper, MD
For more information about the study or enrollment, please contact:
Angela Martino, BSN, RN
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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