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Not yet recruiting NCT05900388

A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)

— Observational Venous Thromboembolism Children Under 2 Years

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rivaroxaban (Xarelto, BAY59-7939), Standard of care (SOC).
Who it may be relevant to
Registry conditions: Venous Thromboembolism, Children Under 2 Years. Basic parameters: up to 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark, France, Spain, Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembolism

Overview

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE). VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening. Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information. The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old. The main information that researchers will collect in this study: * Age, gender, and other information about the child and their illness * Type of VTE treatment given to the child * Occurrence of medically important bleeding and its severity Further information that researchers will collect: * Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE * Return of VTE symptoms * Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study. The data for this study will be collected from electronic health records and health insurance claims data until 2026. Researchers will observe each child during treatment until: * end of the anticoagulation treatment period e.g. discontinuation of all study drugs, * their information is no longer available, or * the study ends.

Interventions

  • Drug Rivaroxaban (Xarelto, BAY59-7939)
    Retrospective cohort analysis using National health registers in Denmark and Sweden; Système National Des Données De Santé (SNDS) in France and Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària (SIDIAP) in Spain
  • Drug Standard of care (SOC)
    Retrospective cohort analysis using National health registers in Denmark and Sweden; Système National Des Données De Santé (SNDS) in France and Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària (SIDIAP) in Spain. SOC including heparins, Vitamin K antagonists (VKAs) and Other Direct oral anticoagulants (DOACs).

Primary outcome measures

  • Descriptive summary of demographic characteristics of patients [Time frame: Retrospective data analysis from 2021 to 2026]
  • Descriptive summary of characteristics of index venous thromboembolism (VTE) [Time frame: Retrospective data analysis from 2021 to 2026]
  • Co-morbidities reported in the previous six months before index date, or since date of birth for children less than six months [Time frame: Retrospective data analysis from 2021 to 2026]
  • Prior treatments reported in the previous six months before index date (or since date of birth for children less than six months) [Time frame: Retrospective data analysis from 2021 to 2026]
  • Comedication during follow-up [Time frame: Retrospective data analysis from 2021 to 2027]
  • Descriptive summary of Health resource utilization in the previous six months before index date (or since date of birth for children less than six months) [Time frame: Retrospective data analysis from 2021 to 2026]
  • Duration of oral, nasogastric/gastric feeding before index date, if available [Time frame: Retrospective data analysis from 2021 to 2026]
  • Substance and class of anticoagulant drug therapy [Time frame: Retrospective data analysis from 2021 to 2027]
  • Duration of use anticoagulant drug therapy [Time frame: Retrospective data analysis from 2021 to 2027]
  • Dosing of anticoagulant drug administration [Time frame: Retrospective data analysis from 2021 to 2027]
Secondary outcome measures (4)
  • Time trends by calendar year in patient characteristics [Time frame: Retrospective data analysis from 2021 to 2026]
  • Time trends by calendar year in anticoagulation treatment patterns [Time frame: Retrospective data analysis from 2021 to 2026]
  • Incidence of recurrent symptomatic VTE according to anticoagulation therapy [Time frame: Retrospective data analysis from 2021 to 2027]
  • Physician specialty and care settings (inpatient care, secondary outpatient care, primary care) for prescriptions of anticoagulation therapy [Time frame: Retrospective data analysis from 2021 to 2027]

Eligibility criteria

Inclusion criteria

  • Evidence of initiation of an anticoagulant therapy (index drug), either rivaroxaban oral suspension or other anticoagulation therapies (heparins, Vitamin K antagonists (VKAs), other Direct oral anticoagulants (DOACs)). Initiation will be defined as a first record of any anticoagulation therapy (rivaroxaban or SOC) without any anticoagulation therapy in the previous 6 months, or since date of birth for children less than 6 months
  • Evidence of a prior VTE diagnosis (index VTE), defined as the presence of at least one primary/main or secondary diagnosis code for VTE recorded in inpatient setting in the previous 30 days
  • Age less than two years on index date.
  • Baseline period for availability of patient data history in the data source. A minimal baseline period of six months before index date for children aged between six months and two years, and a baseline period since birth for children less than six months of age will be required.

Exclusion criteria

\- None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Many locations — Multiple Locations
France · 1 center
  • Many locations — Multiple Locations
Spain · 1 center
  • Many locations — Multiple Locations
Sweden · 1 center
  • Many locations — Multiple Locations

Identifiers

NCT: NCT05900388 · 22195

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗