Venous ThromboembolismXAPAEDUSNCT05900388
A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)
An observational study of Venous Thromboembolism and Children Under 2 Years, run by Bayer at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Venous Thromboembolism, Children Under 2 Years
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- Type of treatment
- Pill or oral medicine
- How many people
- 850 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Sep 2027to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
About this study
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
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.
Read more
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.
- Conditions
- Venous Thromboembolism, Children Under 2 Years
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Standard of care (SOC)
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
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
Standard of care (SOC)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Standard of care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive summary of demographic characteristics of patients
Measured: Retrospective data analysis from 2021 to 2026
Descriptive summary of characteristics of index venous thromboembolism (VTE)
Measured: 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
Measured: 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)
Measured: Retrospective data analysis from 2021 to 2026
Comedication during follow-up
Measured: 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)
Measured: Retrospective data analysis from 2021 to 2026
Duration of oral, nasogastric/gastric feeding before index date, if available
Measured: Retrospective data analysis from 2021 to 2026
Substance and class of anticoagulant drug therapy
For analyzing Index drug therapy and Maintenance therapy.
Measured: Retrospective data analysis from 2021 to 2027
Duration of use anticoagulant drug therapy
For analyzing Index drug therapy and Maintenance therapy.
Measured: Retrospective data analysis from 2021 to 2027
Dosing of anticoagulant drug administration
For analyzing Index drug therapy and Maintenance therapy.
Measured: Retrospective data analysis from 2021 to 2027
Route of anticoagulant drug administration
For analyzing Index drug therapy and Maintenance therapy.
Measured: Retrospective data analysis from 2021 to 2027
Switching to other anticoagulant therapy (Yes/No)
Measured: Retrospective data analysis from 2021 to 2027
Number of successive anticoagulation agents during an anticoagulant treatment period
Measured: Retrospective data analysis from 2021 to 2027
Sequence of successive anticoagulation agents during an anticoagulant treatment period
Measured: Retrospective data analysis from 2021 to 2027
Incidence and severity of major bleeding according to anticoagulation therapy
Measured: Retrospective data analysis from 2021 to 2027
Incidence and severity of clinically Relevant Non-Major (CRNM) bleeding according to anticoagulation therapy
Measured: Retrospective data analysis from 2021 to 2027
Secondary outcomes (4)
Time trends by calendar year in patient characteristics
Description by calendar year of age group at index date and medical history at index date.
Measured: 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.
Measured: Retrospective data analysis from 2021 to 2026
Incidence of recurrent symptomatic VTE according to anticoagulation therapy
Measured: Retrospective data analysis from 2021 to 2027
Physician specialty and care settings (inpatient care, secondary outpatient care, primary care) for prescriptions of anticoagulation therapy
Measured: Retrospective data analysis from 2021 to 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Sep 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900388
- Sponsor's protocol ID
- 22195
- Acronym
- XAPAEDUS
- Status last verified
- Oct 2026
- First submitted
- 10 May 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05900388
- Acronym / sponsor ID
- XAPAEDUS / 22195
- Conditions
- Venous Thromboembolism, Children Under 2 Years
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with VTE | – | Drug: Rivaroxaban (Xarelto, BAY59-7939), Drug: Standard of care (SOC)Pediatric patients under two years who initiate an anticoagulation therapy with rivaroxaban oral suspension or Standard of care (SOC) following a VTE diagnosis. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Pediatric patients with VTE |
| 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). | Drug | Pediatric patients with VTE |
Primary outcome
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
For analyzing Index drug therapy and Maintenance therapy.
Duration of use anticoagulant drug therapy
Time frame: Retrospective data analysis from 2021 to 2027
For analyzing Index drug therapy and Maintenance therapy.
Dosing of anticoagulant drug administration
Time frame: Retrospective data analysis from 2021 to 2027
For analyzing Index drug therapy and Maintenance therapy.
Route of anticoagulant drug administration
Time frame: Retrospective data analysis from 2021 to 2027
For analyzing Index drug therapy and Maintenance therapy.
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Children Under 2 Years, run by Bayer at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, France, Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive summary of demographic characteristics of patients (time frame: Retrospective data analysis from 2021 to 2026). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.