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
- Conditions
- Venous Thromboembolism
- Registration Number
- NCT05966740
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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
- Participation in any randomized clinical trial or use of investigational product, participation in any other observational study is not an exclusion
- Any contraindications to Pradaxa Pellets according to the US Prescribing Information.
- Previous participation in this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence of clinically relevant bleeding events Up to week 52
- Secondary Outcome Measures
Name Time Method Mortality related to thrombotic or thromboembolic events Up to week 52 Incidence of serious adverse events (SAEs) Up to week 52 Occurrence of post-thrombotic syndrome (PTS) Up to week 52 Incidence of adverse events (AEs) Up to week 52 Thrombotic burden at the end of the treatment period vs baseline, i.e. image-based resolution status of the thrombus (complete response, partial response, stable disease, progressive disease) Baseline and up to week 12 Compliance with dabigatran etexilate treatment Up to week 52 Occurence of all bleeding events Up to week 52 Occurrence of recurrent Venous Thromboembolic Event (VTE) Up to week 52 Recurrence of VTE while on treatment Up to week 52 Duration of treatment with dabigatran etexilate Up to week 52
Trial Locations
- Locations (10)
Rady Children's Hospital
🇺🇸San Diego, California, United States
Indiana Hemophilia & Thrombrosis Center
🇺🇸Indianapolis, Indiana, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
University of California, San Diego
🇺🇸La Jolla, California, 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
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Johns Hopkins All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Dayton Children's Hospital
🇺🇸Dayton, Ohio, United States