An observational study in Venous Thromboembolism and Children Under 2 Years, sponsored by Bayer. Not yet recruiting at 4 sites in 4 countries. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Bayer · Observational
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:
Further information that researchers will collect:
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:
694 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.
This study's planned enrollment of 850 is above the median of 700 across 283 observational studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
- None
Pediatric patients under two years who initiate an anticoagulation therapy with rivaroxaban oral suspension or Standard of care (SOC) following a VTE diagnosis.
Drug: Rivaroxaban (Xarelto, BAY59-7939) · 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
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).
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
For analyzing Index drug therapy and Maintenance therapy.
Time frame: Retrospective data analysis from 2021 to 2027
Duration of use anticoagulant drug therapy
For analyzing Index drug therapy and Maintenance therapy.
Time frame: Retrospective data analysis from 2021 to 2027
Dosing of anticoagulant drug administration
For analyzing Index drug therapy and Maintenance therapy.
Time frame: Retrospective data analysis from 2021 to 2027
Route of anticoagulant drug administration
For analyzing Index drug therapy and Maintenance therapy.
Time frame: Retrospective data analysis from 2021 to 2027
Switching to other anticoagulant therapy (Yes/No)
Time frame: Retrospective data analysis from 2021 to 2027
Number of successive anticoagulation agents during an anticoagulant treatment period
Time frame: Retrospective data analysis from 2021 to 2027
Sequence of successive anticoagulation agents during an anticoagulant treatment period
Time frame: Retrospective data analysis from 2021 to 2027
Incidence and severity of major bleeding according to anticoagulation therapy
Time frame: Retrospective data analysis from 2021 to 2027
Incidence and severity of clinically Relevant Non-Major (CRNM) bleeding according to anticoagulation therapy
Time frame: Retrospective data analysis from 2021 to 2027
Time trends by calendar year in patient characteristics
Description by calendar year of age group at index date and medical history at index date.
Time frame: Retrospective data analysis from 2021 to 2026
Time trends by calendar year in anticoagulation treatment patterns
Description by calendar year of class of anticoagulation therapy at initiation.
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
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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