An observational study in Venous Thromboembolism, sponsored by Boehringer Ingelheim. Terminated at 10 sites in United States. Open to participants aged 3 Months to 12 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Boehringer Ingelheim · Observational
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.
693 studies on the registry are indexed under Venous Thromboembolism; 151 are open to participants now.
This study's enrollment of 5 is below the median of 700 across 282 observational studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Pediatric patients aged 3 months to less than 12 years at the time of Pradaxa Pellets initiation
Initiation of Pradaxa Pellets administration either as initial or subsequent therapy:
Exclusion Criteria:
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.
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.
Time frame: 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 Recurrent Venous Thromboembolic Event (VTE)
The occurrence of VTE is reported as the number of participants with recurrent VTE including both symptomatic and asymptomatic events. Symptomatic recurrent VTE is defined as radiologically-confirmed new venous thrombotic or embolic burden at least 7 days post-diagnosis of the index VTE, accompanied by signs and/or symptoms attributable to the new thromboembolism. Asymptomatic VTE was defined by new thrombotic/embolic burden as disclosed by comparison of end-of-treatment imaging versus baseline imaging of the vascular region involved by the index VTE.
Time frame: 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
Number of participants who died with thrombotic or thromboembolic events.
Time frame: 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
The occurrence of all-bleeding events is reported as the number of participants experiencing any of the bleeding event described. All bleeding events were defined as the composite of major bleeding events (MBE), clinically relevant non-major (CRNM) bleeding events and minor bleeding events but not leading to hospitalization, increased level of inpatient care, or an intervention by the medical team. Minor bleeding events were defined as any overt or macroscopic evidence of bleeding that does not fulfil the criteria for major bleeding, CRNM bleeding, or important bleeding without intervention according to recommendations from international thrombosis and hemostasis committees.
Time frame: 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)
Occurrence of post-thrombotic syndrome (PTS) is reported as the number of participants with PTS. The presence of PTS was evaluated by the Villalta Scale Modified for Children, the Manco-Johnson instrument, or other validated pediatric PTS instrument employed in routine clinical care, according to recommendations from international thrombosis and hemostasis committees.
Time frame: 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)
Incidence of adverse events is reported as number of participants with any adverse event (AEs).
Time frame: 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 Serious Adverse Events (SAEs)
Incidence of serious adverse events is reported as number of participants with serious adverse event (SAEs).
Time frame: 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.
Thrombotic Burden at the End of Treatment
Number of participants with thrombotic burden at the end of the treatment period compared to baseline was quantified by image-based resolution status of the thrombus at the discretion of the treating physician, based on the type and location of the initial diagnosis of the thromboembolism. When appropriate, the same approach used for the baseline evaluations was utilized.
Time frame: 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.
Recurrence of Venous Thromboembolic Event (VTE) While on Treatment
Number of participants with new or recurrent VTE occurring at least 7 days after diagnosis of the VTE captured on the baseline VTE form (index VTE).
Time frame: 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.
Duration of Treatment With Dabigatran Etexilate
The median duration of the dabigatran etexilate (Pradaxa Pellets) treatment is reported.
Time frame: From first Pradaxa Pellets exposure until its discontinuation. Up to 370 days.
Compliance With Dabigatran Etexilate Treatment
Number of participants complying with dabigatran etexilate (Pradaxa Pellets) treatment. Compliance was defined as not missing 0-1 treatment dose since the last visit, as evaluated at each time point. Unscheduled follow-up was defined as patient contact in between any scheduled study visit.
Time frame: From first Pradaxa Pellets exposure until its discontinuation. At 6-week, 3-months, 6-month, and 12-month follow-up, and at unscheduled follow-up (up to 370 days).
Incidence of Adverse Events Leading to Drug Discontinuation
Incidence of adverse events leading to discontinuation of Pradaxa Pellets is reported as the number of participants.
Time frame: 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.
Non-interventional, multi-center study in the United States (US) based on newly collected data of pediatric patients receiving Pradaxa pellets as anticoagulation care: after being treated with parenteral anticoagulants for the treatment of acute venous thromboembolic events (VTE); to reduce the risk of VTE recurrence after treatment of VTE; for off-label use in the treatment of VTE or to reduce the risk of VTE recurrence.
| Milestone | Pradaxa-treated Patients |
|---|---|
| Started | 5 |
| Completed | 4 |
| Not completed | 1 |
| Withdrew: Early termination | 1 |
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.
| Participants | Pradaxa-treated Patients |
|---|---|
| Cumulative Incidence of Clinically Relevant Bleeding Events | 1 |
The occurrence of VTE is reported as the number of participants with recurrent VTE including both symptomatic and asymptomatic events. Symptomatic recurrent VTE is defined as radiologically-confirmed new venous thrombotic or embolic burden at least 7 days post-diagnosis of the index VTE, accompanied by signs and/or symptoms attributable to the new thromboembolism. Asymptomatic VTE was defined by new thrombotic/embolic burden as disclosed by comparison of end-of-treatment imaging versus baseline imaging of the vascular region involved by the index VTE.
| Participants | Pradaxa-treated Patients |
|---|---|
| Occurrence of Recurrent Venous Thromboembolic Event (VTE) | 2 |
Number of participants who died with thrombotic or thromboembolic events.
| Participants | Pradaxa-treated Patients |
|---|---|
| Mortality Related to Thrombotic or Thromboembolic Events | 0 |
The occurrence of all-bleeding events is reported as the number of participants experiencing any of the bleeding event described. All bleeding events were defined as the composite of major bleeding events (MBE), clinically relevant non-major (CRNM) bleeding events and minor bleeding events but not leading to hospitalization, increased level of inpatient care, or an intervention by the medical team. Minor bleeding events were defined as any overt or macroscopic evidence of bleeding that does not fulfil the criteria for major bleeding, CRNM bleeding, or important bleeding without intervention according to recommendations from international thrombosis and hemostasis committees.
| Participants | Pradaxa-treated Patients |
|---|---|
| Occurrence of All Bleeding Events | 1 |
Occurrence of post-thrombotic syndrome (PTS) is reported as the number of participants with PTS. The presence of PTS was evaluated by the Villalta Scale Modified for Children, the Manco-Johnson instrument, or other validated pediatric PTS instrument employed in routine clinical care, according to recommendations from international thrombosis and hemostasis committees.
| Participants | Pradaxa-treated Patients |
|---|---|
| Occurrence of Post-thrombotic Syndrome (PTS) | 0 |
Incidence of adverse events is reported as number of participants with any adverse event (AEs).
| Participants | Pradaxa-treated Patients |
|---|---|
| Incidence of Adverse Events (AEs) | 4 |
Incidence of serious adverse events is reported as number of participants with serious adverse event (SAEs).
| Participants | Pradaxa-treated Patients |
|---|---|
| Incidence of Serious Adverse Events (SAEs) | 2 |
Number of participants with thrombotic burden at the end of the treatment period compared to baseline was quantified by image-based resolution status of the thrombus at the discretion of the treating physician, based on the type and location of the initial diagnosis of the thromboembolism. When appropriate, the same approach used for the baseline evaluations was utilized.
| Participants | Pradaxa-treated Patients |
|---|---|
| Thrombotic Burden at the End of Treatment | 0 |
Number of participants with new or recurrent VTE occurring at least 7 days after diagnosis of the VTE captured on the baseline VTE form (index VTE).
| Participants | Pradaxa-treated Patients |
|---|---|
| Recurrence of Venous Thromboembolic Event (VTE) While on Treatment | 2 |
The median duration of the dabigatran etexilate (Pradaxa Pellets) treatment is reported.
| Days | Pradaxa-treated Patients |
|---|---|
| Duration of Treatment With Dabigatran Etexilate | 118.0 (28 to 370) |
Number of participants complying with dabigatran etexilate (Pradaxa Pellets) treatment. Compliance was defined as not missing 0-1 treatment dose since the last visit, as evaluated at each time point. Unscheduled follow-up was defined as patient contact in between any scheduled study visit.
| Participants | Pradaxa-treated Patients |
|---|---|
| 6 Week follow-up | 4 |
| 3 Months follow-up | 1 |
| 6 Months follow-up | 2 |
| 12 Months follow-up | 0 |
| Unscheduled follow-up | 1 |
Incidence of adverse events leading to discontinuation of Pradaxa Pellets is reported as the number of participants.
| Participants | Pradaxa-treated Patients |
|---|---|
| Incidence of Adverse Events Leading to Drug Discontinuation | 1 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pradaxa-treated Patients | 0/5 (0%) | 2/5 (40%) | 4/5 (80%) |
| Event | Pradaxa-treated Patients |
|---|---|
| Atrial thrombosisCardiac disorders | 1/5 |
| Cardiac ventricular thrombosisCardiac disorders | 1/5 |
| Chest painCardiac disorders | 1/5 |
| Tricuspid valve incompetenceCardiac disorders | 1/5 |
| PyrexiaGeneral disorders | 1/5 |
| Rhinovirus infectionInfections and infestations | 1/5 |
| Subacute endocarditisInfections and infestations | 1/5 |
| Event | Pradaxa-treated Patients |
|---|---|
| PyrexiaGeneral disorders | 4/5 |
| FatigueGeneral disorders | 2/5 |
| AnaemiaBlood and lymphatic system disorders | 1/5 |
| Increased tendency to bruiseBlood and lymphatic system disorders | 1/5 |
| Iron deficiency anaemiaBlood and lymphatic system disorders | 1/5 |
| TachycardiaCardiac disorders | 1/5 |
| Tricuspid valve incompetenceCardiac disorders | 1/5 |
| Adrenal insufficiencyEndocrine disorders | 1/5 |
| Abdominal painGastrointestinal disorders | 1/5 |
| ConstipationGastrointestinal disorders | 1/5 |
All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa pellets.
| Age, Continuous(Years) | Pradaxa-treated Patients |
|---|---|
| Mean | 7.73 ± 3.13 |
| Sex: Female, Male(Participants) | Pradaxa-treated Patients |
|---|---|
| Female | 3 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Pradaxa-treated Patients |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Pradaxa-treated Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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