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

Study Overview
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Brief Summary
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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
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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

Conditions
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Venous Thromboembolism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 venous thromboembolic events (VTE) Treatment to reduce the risk of recurrence of VTE Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients with VTE and/or at risk for VTE<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any bleeding-related events |  | Up to week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Occurrence of any non-contiguous venous thromboembolic events (VTE) while on treatment |  | Up to week 52 | 
| Mortality related to thrombotic or thromboembolic events |  | Up to week 52 | 
| Occurrence of post-thrombotic syndrome (PTS) |  | Up to week 52 | 
| Recurrence of VTE while on treatment |  | Up to week 52 | 
| Incidence of adverse events (AEs) |  | Up to week 52 | 
| Incidence of serious adverse events (SAEs) |  | Up to week 52 | 
| Frequency of patients who discontinued treatment due to an AE |  | Up to week 52 | 
| Duration of treatment with dabigatran etexilate |  | Up to week 52 | 
| Compliance with dabigatran etexilate treatment |  | Up to week 52 |