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

Boehringer Ingelheim

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Venous Thromboembolism

Interventions

Dabigatran Etexilate (DE)DRUG

Dabigatran Etexilate (DE)

Eligibility

Sex: ALLMax age: 2 Years

Medical Language ↔ Plain English

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)

Locations (6)

Charité - Universitätsmedizin Berlin

Berlin, Germany

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Hospital Sant Joan de Déu

Barcelona, Spain

Outcomes

Primary Outcomes

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).)

Time frame: up to 6 months

Secondary Outcomes

Incidence of Adverse Events (AEs)

Time frame: up to 6 months

Incidence of Serious Adverse Events (SAEs)

Time frame: up to 6 months

Data from ClinicalTrials.gov

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