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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-19

Study Completion Date

2025-04-28

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.

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric patients with VTE and/or at risk for VTE

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No