Clinical trial NCT05900388: A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Venous Thromboembolism
Children Under 2 Years
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2023-06-12
Enrollment: 850
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged under two years who initiate an anticoagulation therapy with rivaroxaban oral suspension or any other anticoagulation drug (index date) following a VTE diagnosis during year 2021 to 2026.

Brief summary: 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.


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

Primary outcomes:
measure: Descriptive summary of demographic characteristics of patients
timeFrame: Retrospective data analysis from 2021 to 2026
measure: Descriptive summary of characteristics of index venous thromboembolism (VTE)
timeFrame: Retrospective data analysis from 2021 to 2026
measure: Co-morbidities reported in the previous six months before index date, or since date of birth for children less than six months
timeFrame: Retrospective data analysis from 2021 to 2026
measure: Prior treatments reported in the previous six months before index date (or since date of birth for children less than six months)
timeFrame: Retrospective data analysis from 2021 to 2026
measure: Comedication during follow-up
timeFrame: Retrospective data analysis from 2021 to 2027
measure: 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)
timeFrame: Retrospective data analysis from 2021 to 2026
measure: Duration of oral, nasogastric/gastric feeding before index date, if available
timeFrame: Retrospective data analysis from 2021 to 2026
measure: Substance and class of anticoagulant drug therapy
timeFrame: Retrospective data analysis from 2021 to 2027
measure: Duration of use anticoagulant drug therapy
timeFrame: Retrospective data analysis from 2021 to 2027
measure: Dosing of anticoagulant drug administration
timeFrame: Retrospective data analysis from 2021 to 2027
measure: Route of anticoagulant drug administration
timeFrame: Retrospective data analysis from 2021 to 2027
measure: Switching to other anticoagulant therapy (Yes/No)
timeFrame: Retrospective data analysis from 2021 to 2027
measure: Number of successive anticoagulation agents during an anticoagulant treatment period
timeFrame: Retrospective data analysis from 2021 to 2027
measure: Sequence of successive anticoagulation agents during an anticoagulant treatment period
timeFrame: Retrospective data analysis from 2021 to 2027
measure: Incidence and severity of major bleeding according to anticoagulation therapy
timeFrame: Retrospective data analysis from 2021 to 2027
measure: Incidence and severity of clinically Relevant Non-Major (CRNM) bleeding according to anticoagulation therapy
timeFrame: Retrospective data analysis from 2021 to 2027
Secondary outcomes:
measure: Time trends by calendar year in patient characteristics
timeFrame: Retrospective data analysis from 2021 to 2026
measure: Time trends by calendar year in anticoagulation treatment patterns
timeFrame: Retrospective data analysis from 2021 to 2026
measure: Incidence of recurrent symptomatic VTE according to anticoagulation therapy
timeFrame: Retrospective data analysis from 2021 to 2027
measure: Physician specialty and care settings (inpatient care, secondary outpatient care, primary care) for prescriptions of anticoagulation therapy
timeFrame: Retrospective data analysis from 2021 to 2027
Other outcomes:
Locations:
city: Multiple Locations
country: Denmark
facility: Many locations
city: Multiple Locations
country: France
facility: Many locations
city: Multiple Locations
country: Spain
facility: Many locations
city: Multiple Locations
country: Sweden
facility: Many locations
Study officials:
References: