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 Overview
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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.

Official Title
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Safety of Dabigatran Etexilate (DE) for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Paediatric Patients From Birth to Less Than 2 Years of Age: a Prospective European Non-interventional Cohort Study Based on New Data Collection

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Dabigatran Etexilate (DE)


Participation Criteria
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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)

Ages Eligible for Study
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Maximum Age: 2 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 eligible for Dabigatran Etexilate (DE) VTE treatment and secondary VTE prevention<br> | Drug: Dabigatran Etexilate (DE)<br>* Dabigatran Etexilate (DE)<br>* Other names: Pradaxa®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any bleeding events defined as Major Bleeding Events (MBE) or Non-Major Bleeding Events (Non-MBE) | Major bleeding defined as: Fatal Bleeding, Clinically overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL (20 g/L) in a 24-hour period, Bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the central nervous system, Bleeding that requires surgical intervention in an operating suite. Non-Major bleeding defined as: - Any overt or macroscopic evidence of bleeding that does not fulfil the criteria for major bleeding. (Criteria for differentiation of Major Bleeding Events (MBEs) and Non-MBEs by the Perinatal and Paediatric Haemostasis Subcommittee of the Scientific and Standardization Committee (SSC) of the International Society on Thrombosis and Haemostasis (ISTH).) | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | up to 6 months | 
| Incidence of Serious Adverse Events (SAEs) |  | up to 6 months |