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

Bayer4 个研究点分布在 4 个国家目标入组 850 人开始时间: 2026年9月1日最近更新: 2026年7月7日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 850
试验地点: 4
主要终点: Descriptive summary of demographic characteristics of patients

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Retrospective

入排标准

年龄范围: — 至 2 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

未提供

研究组 & 干预措施

Pediatric patients with VTE

Pediatric patients under two years who initiate an anticoagulation therapy with rivaroxaban oral suspension or Standard of care (SOC) following a VTE diagnosis.

干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)

Pediatric patients with VTE

Pediatric patients under two years who initiate an anticoagulation therapy with rivaroxaban oral suspension or Standard of care (SOC) following a VTE diagnosis.

干预措施: Standard of care (SOC) (Drug)

结局指标

主要结局

Descriptive summary of demographic characteristics of patients

时间窗: Retrospective data analysis from 2021 to 2026

Descriptive summary of characteristics of index venous thromboembolism (VTE)

时间窗: 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

时间窗: 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)

时间窗: Retrospective data analysis from 2021 to 2026

Comedication during follow-up