DaPaR: 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 Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pediatric patients eligible for Dabigatran Etexilate (DE) VTE treatment and secondary VTE prevention
|
Drug: Dabigatran Etexilate (DE)
Dabigatran Etexilate (DE)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of any bleeding events defined as Major Bleeding Events (MBE) or Non-Major Bleeding Events (Non-MBE) [up to 6 months]
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).)
Secondary Outcome Measures
- Incidence of Adverse Events (AEs) [up to 6 months]
- Incidence of Serious Adverse Events (SAEs) [up to 6 months]
Eligibility Criteria
Criteria
Inclusion criteria:
-
Written informed consent from parents/care givers
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Children from birth to less than 2 years of age
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Initiation of Dabigatran Etexilate (DE) administration:
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for treatment of Venous thromboembolism (VTE) or/and
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prevention of recurrent VTE due to presence of unresolved clinical VTE risk factor(s).
Exclusion criteria:
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Participation in any Randomised Clinical Trial or use of any investigational product
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Any contraindications to DE according to the EU Summary of Product Characteristics (SmPC)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1160-0307