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TerminatedNo phase
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
Key facts
- Who runs it
- Boehringer Ingelheim
- Where
- Austin, Charleston, Cincinnati, Dayton, Indianapolis, La Jolla, Nashville, New Haven, San Diego, and St. Petersburg, United StatesSee the 10 sites
- Trial code
- Status
- Terminated
- People taking part
- 5 people enrolled
- Started
- 19 Apr 2024
- Ended
- 28 Apr 2025
- Type of study
- Observational
- Record updated
- 2 June 2026
Who can take part
- Age
- 3 months to 12 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Pediatric patients aged 3 months to less than 12 years at the time of Pradaxa Pellets initiation
- Written informed consent from parents/care givers and patient assent if age appropriate
- Initiation of Pradaxa Pellets administration either as initial or subsequent therapy:; Treatment of VTE; Treatment to reduce the risk of recurrence of VTE
Who cannot take part
- Participation in any randomized clinical trial or use of investigational product, participation in any other observational study is not an exclusion
- Previous participation in this study
- Any contraindications to Pradaxa Pellets according to the US Prescribing Information
Where in United States
- Dell Children's AscensionAustin, United States
- MUSC (Medical university of South Carolina)Charleston, United States
- Cincinnati Children's HospitalCincinnati, United States
- Dayton Children's HospitalDayton, United States
- Indiana Hemophilia & Thrombrosis CenterIndianapolis, United States
- University of California San DiegoLa Jolla, United States
- Vanderbilt UniversityNashville, United States
- Yale University School Of MedicineNew Haven, United States
- Rady Children's HospitalSan Diego, United States
- Johns Hopkins All Children's HospitalSt. Petersburg, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Pradaxa-treated patients
Pediatric patients with acute venous thromboembolic events (VTE) and/or at risk of recurrent VTE due to the presence of unresolved clinical risk factors received Pradaxa Pellets orally, either according to the prescribing label or off-label.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 2 June 2026