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New study tracks xarelto safety in infants with blood clots

NCT ID NCT05900388

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This observational study will collect data from health records of 850 children under 2 years old who have venous thromboembolism (blood clots). The goal is to see how doctors prescribe rivaroxaban (Xarelto) and other standard blood thinners, and to track any serious bleeding. No new treatments or tests are given—researchers simply analyze existing information from national health databases in Denmark, Sweden, France, and Spain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rivaroxaban (Xarelto) oral suspension
What this could lead to
If successful, this study could provide better information on how rivaroxaban is used and how safe it is in very young children with blood clots.
What could go wrong
This is an observational study that only looks at existing data, so it cannot prove cause and effect. Results may be limited by the quality of the records and may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 850 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Up to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

venous thromboembolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Children under 2 years Venous thromboembolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Many locations

    Multiple Locations, Denmark

  • Many locations

    Multiple Locations, France

  • Many locations

    Multiple Locations, Spain

  • Many locations

    Multiple Locations, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.