Venous Thromboembolism
Conditions
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Children's Hospital Acquired Thrombosis consortium
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of Clinically Relevant 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | Number of participants who died with thrombotic or thromboembolic events. |
| 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. | 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. |
| 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. | 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. |
| 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. | Incidence of adverse events is reported as number of participants with any adverse event (AEs). |
| Incidence of Serious Adverse Events (SAEs) | 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 is reported as number of participants with serious adverse event (SAEs). |
| Thrombotic Burden at the End of Treatment | 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. | 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. |
| Recurrence of Venous Thromboembolic Event (VTE) While on Treatment | 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. | 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). |
| Duration of Treatment With Dabigatran Etexilate | From first Pradaxa Pellets exposure until its discontinuation. Up to 370 days. | The median duration of the dabigatran etexilate (Pradaxa Pellets) treatment is reported. |
| Compliance With Dabigatran Etexilate Treatment | 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). | 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. |
| Incidence of Adverse Events Leading to Drug Discontinuation | 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 leading to discontinuation of Pradaxa Pellets is reported as the number of participants. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Patients were excluded if they had any contraindications to Pradaxa Pellets according to the US Prescribing Information, were participating in any randomized clinical trial, or using any investigational product.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 7.73 Years STANDARD_DEVIATION 3.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 2 / 5 |
Outcome results
None listed