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

Withdrawn

• Conditions: Venous Thromboembolism
• Interventions: Drug: Dabigatran Etexilate (DE)

• Registration Number: NCT05536791
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-13
• Study Start: 2022-11-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric patients eligible for Dabigatran Etexilate (DE) VTE treatment and secondary VTE prevention	Dabigatran Etexilate (DE)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events (SAEs)	up to 6 months
Incidence of Adverse Events (AEs)	up to 6 months

Trial Locations

Locations (6)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Radboud Universitair Medisch Centrum; 🇳🇱 Nijmegen, Netherlands

Hospital Sant Joan de Déu; 🇪🇸 Barcelona, Spain

Hospital Materno Infantil Gregorio Marañón; 🇪🇸 Madrid, Spain

Karolinska Universitetssjukhuset; 🇸🇪 Stockholm, Sweden

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands