Study Stopped
No patients were screened in the study.
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
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
1 other identifier
observational
N/A
4 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2022
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedStudy Start
First participant enrolled
November 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJune 26, 2024
June 1, 2024
1.9 years
September 9, 2022
June 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Incidence of Adverse Events (AEs)
up to 6 months
Incidence of Serious Adverse Events (SAEs)
up to 6 months
Study Arms (1)
Pediatric patients eligible for Dabigatran Etexilate (DE) VTE treatment and secondary VTE prevention
Interventions
Dabigatran Etexilate (DE)
Eligibility Criteria
Paediatric patients from birth to \< 2 years of age considered by investigator after screening as eligible for Dabigatran Etexilate (DE) treatment of acute Venous thromboembolism (VTE) or secondary prevention of recurrent VTE will be enrolled in the Post-Authorization Safety Study (PASS).
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GL, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Hospital Sant Joan de Déu
Barcelona, 08950, Spain
Hospital Materno Infantil Gregorio Marañón
Madrid, 28009, Spain
Karolinska Universitetssjukhuset
Stockholm, 171 76, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 13, 2022
Study Start
November 24, 2022
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
June 26, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.