WithdrawnNot Applicable

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

Stopped: No patients were screened in the study.

Germany, Netherlands, Spain0Started 2022-11-24

Plain-language 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.

Who can participate

Age range2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Incidence of any bleeding events defined as Major Bleeding Events (MBE) or Non-Major Bleeding Events (Non-MBE)

Timeframe: up to 6 months

Trial details

NCT IDNCT05536791

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Venous Thromboembolism trials