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
Status: Terminated
Location: See all (10) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 12
Healthy Volunteers: f
View:
∙ 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
Locations
United States
California
University of California, San Diego
La Jolla
Rady Children's Hospital
San Diego
Connecticut
Yale University School of Medicine
New Haven
Florida
Johns Hopkins All Children's Hospital
St. Petersburg
Indiana
Indiana Hemophilia & Thrombrosis Center
Indianapolis
Ohio
Cincinnati Children's Hospital
Cincinnati
Dayton Children's Hospital
Dayton
South Carolina
MUSC (Medical university of South Carolina)
Charleston
Tennessee
Vanderbilt University
Nashville
Texas
Dell Children's Ascension
Austin
Time Frame
Start Date: 2024-04-19
Completion Date: 2025-04-28
Participants
Target number of participants: 6
Treatments
Pediatric patients with VTE and/or at risk for VTE
Related Therapeutic Areas
Sponsors
Leads: Boehringer Ingelheim
Collaborators: Children's Hospital Acquired Thrombosis consortium