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

Venous Thromboembolism Clinical Trial

— DaPaR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536791
• Other study ID #: 1160-0307
• Status: Recruiting
• Start date: November 24, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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)

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Dabigatran Etexilate (DE)
Dabigatran Etexilate (DE)

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno
Czechia	University Hospital Olomouc	Olomouc
Czechia	University Hospital Ostrava	Ostrava
Finland	Tampere University Hospital	Tampere
Germany	Charité - Universitätsmedizin Berlin	Berlin
Netherlands	Radboud Universitair Medisch Centrum	Nijmegen
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Spain	Hospital Sant Joan de Déu	Barcelona
Spain	Hospital Materno Infantil Gregorio Marañón	Madrid
Sweden	Karolinska Universitetssjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Czechia,  Finland,  Germany,  Netherlands,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).)	up to 6 months
Secondary	Incidence of Adverse Events (AEs)		up to 6 months
Secondary	Incidence of Serious Adverse Events (SAEs)		up to 6 months

External Links

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