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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05536791

Acronym

DaPaR

Enrollment

Registered

2022-09-13

Start date

2022-11-24

Completion date

2024-10-01

Last updated

2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

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.

Interventions

DRUGDabigatran Etexilate (DE)

Dabigatran Etexilate (DE)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Incidence of Adverse Events (AEs)	up to 6 months
Incidence of Serious Adverse Events (SAEs)	up to 6 months

Countries

Germany, Netherlands, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026