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 (DaPaR)

Boehringer Ingelheim

Status: Withdrawn

Conditions: Venous Thromboembolism

Treatments: Drug: Dabigatran Etexilate (DE)

Study type: Observational

Funder types: Industry

Identifiers

NCT05536791

1160-0307

Details and patient eligibility

About

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.

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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)

Trial design

0 participants in 1 patient group

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

Treatment:

Drug: Dabigatran Etexilate (DE)