A Study in Europe Based on Medical Records That Looks at the Safety of Dabigatran in Children Below 2 Years of Age 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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-24

Study Completion Date

2024-10-01

Brief Summary

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The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.

The non-interventional study will be conducted in paediatric hospitals or paediatric departments of EEA member states where Venous thromboembolism (VTE) patients of the evaluated age group are treated.

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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 eligible for Dabigatran Etexilate (DE) VTE treatment and secondary VTE prevention

Dabigatran Etexilate (DE)

Intervention Type DRUG

Dabigatran Etexilate (DE)

Interventions

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Dabigatran Etexilate (DE)

Intervention Type DRUG

Other Intervention Names

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Pradaxa®

Eligibility Criteria

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Inclusion Criteria

* Written informed consent from parents/care givers
* Children from birth to less than 2 years of age
* Initiation of Dabigatran Etexilate (DE) administration:

* for treatment of Venous thromboembolism (VTE) or/and
* prevention of recurrent VTE due to presence of unresolved clinical VTE risk factor(s).

Exclusion Criteria

* Participation in any Randomised Clinical Trial or use of any investigational product
* Any contraindications to DE according to the EU Summary of Product Characteristics (SmPC)

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No