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

Launched by BAYER · Jun 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use and safety of a medication called rivaroxaban in very young children under 2 years old who have a condition known as venous thromboembolism (VTE). VTE occurs when blood clots form in the veins, which can be painful and, in serious cases, can block blood flow to the lungs. The trial aims to gather information on how rivaroxaban and other treatments are used in these children, how effective they are, and if there are any safety concerns, especially regarding bleeding.

To be eligible for this study, children must be under 2 years old, have been diagnosed with VTE, and be starting treatment with rivaroxaban or other blood-thinning medicines. Participants will not undergo any extra tests; instead, researchers will collect information from their medical records until 2026. This will include details like the type of treatment received and any important health issues that arise during treatment. The study is observational, meaning it will only look at data from children receiving their usual care, and it is not yet recruiting participants.

Gender

ALL

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