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A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
Sponsor: Boehringer Ingelheim
Summary
The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.
Official title: Safety and Effectiveness of Pradaxa Oral Pellet Formulation for Treatment of Acute Venous Thromboembolic Events (VTE) and/or for Risk Reduction of Recurrence of VTE in Pediatric Patients Aged 3 Months to Less Than 12 Years in a Real World Setting: a Prospective Non-interventional Study Conducted in the United States
Key Details
Gender
All
Age Range
3 Months - 12 Years
Study Type
OBSERVATIONAL
Enrollment
5
Start Date
2024-04-19
Completion Date
2025-04-28
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Locations (10)
University of California, San Diego
La Jolla, California, United States
Rady Children's Hospital
San Diego, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Indiana Hemophilia & Thrombrosis Center
Indianapolis, Indiana, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
MUSC (Medical university of South Carolina)
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Dell Children's Ascension
Austin, Texas, United States