A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
Safety and Effectiveness of Pradaxa Oral Pellet Formulation for Treatment of Acute Venous Thromboembolic Events (VTE) and/or for Risk Reduction of Recurrence of VTE in Pediatric Patients Aged 3 Months to Less Than 12 Years in a Real World Setting: a Prospective Non-interventional Study Conducted in the United States
1 other identifier
observational
5
1 country
10
Brief Summary
The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2024
Shorter than P25 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedStudy Start
First participant enrolled
April 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2025
CompletedResults Posted
Study results publicly available
June 2, 2026
CompletedJune 2, 2026
May 1, 2026
1 year
July 21, 2023
April 21, 2026
June 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative Incidence of Clinically Relevant Bleeding Events
Cumulative incidence of clinically relevant bleeding events was reported as the number of participants with clinically relevant bleeding events, defined as the composite of major bleeding events (MBE) and clinically relevant non-major (CRNM) bleeding events, according to recommendations from international thrombosis and hemostasis committees. MBE were defined as: fatal bleeding; clinically overt bleeding associated with a decrease in hemoglobin of at least 2 grams/deciliter in a 24-hour period; critical site bleeding; bleeding that required an intervention via invasive procedure; and overt bleeding for which a reversal agent was administered. CRNM bleeding was defined as: overt bleeding for which a blood product was administered and did not meet the criteria for major bleeding; bleeding that resulted in a medical or procedural intervention not meeting major bleeding criteria, including a medication change; and bleeding that resulted in hospitalization or an increased level of care.
From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days.
Secondary Outcomes (11)
Occurrence of Recurrent Venous Thromboembolic Event (VTE)
From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days.
Mortality Related to Thrombotic or Thromboembolic Events
From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days.
Occurrence of All Bleeding Events
From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days.
Occurrence of Post-thrombotic Syndrome (PTS)
From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days.
Incidence of Adverse Events (AEs)
From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days.
- +6 more secondary outcomes
Study Arms (1)
Pradaxa-treated patients
Pediatric patients with acute venous thromboembolic events (VTE) and/or at risk of recurrent VTE due to the presence of unresolved clinical risk factors received Pradaxa Pellets orally, either according to the prescribing label or off-label.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Any contraindications to Pradaxa Pellets according to the US Prescribing Information.
- Previous participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of California, San Diego
La Jolla, California, 92093, United States
Rady Children's Hospital
San Diego, California, 92123, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Indiana Hemophilia & Thrombrosis Center
Indianapolis, Indiana, 46260, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
MUSC (Medical university of South Carolina)
Charleston, South Carolina, 29425, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Dell Children's Ascension
Austin, Texas, 78723, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The number of Pradaxa Pellets prescriptions was very low, making the enrollment of a sufficient number of patients over the course of the trial unlikely. The study was terminated after 1.5 years with 5 patients enrolled.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2023
First Posted
August 1, 2023
Study Start
April 19, 2024
Primary Completion
April 28, 2025
Study Completion
April 28, 2025
Last Updated
June 2, 2026
Results First Posted
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.