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Blood thinner pellets tested in kids with clots

NCT ID NCT05966740

Disease control Sponsor: Boehringer Ingelheim 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the safety and effectiveness of Pradaxa oral pellets in children aged 3 months to 12 years who had blood clots (venous thromboembolism). The goal was to see how often bleeding or new clots occurred in real-world use. Only 5 children were enrolled before the study was terminated, so the findings are very limited.

What this could mean

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

Active substance
Pradaxa (dabigatran etexilate) oral pellets
What this could lead to
If successful, this study could provide real-world evidence that Pradaxa pellets are safe and effective for treating blood clots in young children.
What could go wrong
The study was terminated early with only 5 participants, so results are very limited. As an observational study, it cannot prove cause and effect.

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

5 people

The number who actually took part.

Started

Apr 2024

Finished

Apr 2025

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

Pediatric patients aged 3 months to less than 12 years, who may be considered for anticoagulation with Pradaxa Pellets due to venous thromboembolic events (VTE), are usually treated in neonatology, pediatric general surgery, cardiac surgery or intensive care units. Pediatric patients with anticoagulation with Pradaxa Pellets for the prevention of recurrent VTE are usually evaluated by pediatric hematologists in pediatric hematology units. Any of these patients that are prescribed Pradaxa pellets may be considered for inclusion into this study.

Ages

3 months to 12 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: Pediatric patients aged 3 months to less than 12 years at the time of Pradaxa Pellets initiation * Written informed consent from parents/care givers and patient assent if age appropriate * Initiation of Pradaxa Pellets administration either as initial or subsequent therapy: * Treatment of VTE * Treatment to reduce the risk of recurrence of VTE Exclusion Criteria: * Participation in any randomized clinical trial or use of investigational product, participation in any other observational study is not an exclusion * Any contraindications to Pradaxa Pellets according to the US Prescribing Information. * Previous participation in this study.

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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.

Venous thromboembolism

Contacts and locations

Locations

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Dayton Children's Hospital

    Dayton, Ohio, 45404, United States

  • Dell Children's Ascension

    Austin, Texas, 78723, United States

  • Indiana Hemophilia & Thrombrosis Center

    Indianapolis, Indiana, 46260, United States

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701, United States

  • MUSC (Medical university of South Carolina)

    Charleston, South Carolina, 29425, United States

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • University of California, San Diego

    La Jolla, California, 92093, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06519, United States

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