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Blood thinner safety check in kids after heart surgery

NCT ID NCT06193863

Disease control 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Updated 1 time

Summary

This study looks at children with congenital heart disease who take the blood thinner rivaroxaban after a Fontan procedure. The goal is to see how often serious or minor bleeding happens. Researchers will collect data from regular doctor visits for up to 2 years. No extra tests or visits are required.

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

61 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Dec 2026

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

Patients under the age of 18 years with a diagnosis of CHD who had undergone the Fontan procedure treated with rivaroxaban has been made by the treating physician before study enrollment.

Ages

Up to 18 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: * Patients under the age of 18 years * Patients diagnosed with CHD who had undergone the Fontan procedure by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with rivaroxaban by the investigator under routine clinical practice * Informed consent form obtained from a legal representative Exclusion Criteria: * Participation in an investigational program with interventions outside of routine clinical practice * Contraindications according to the local marketing authorization * Previous treatment with rivaroxaban

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Conditions

The condition(s) this trial relates to.

congenital heart disease venous thromboembolism prevention target

As listed by the trial registrant

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

Children Congenital heart disease Fontan procedure Prevention of venous thromboembolism

Contacts and locations

Locations

  • Many Locations

    Many Locations, Japan

More trials for these conditions

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