Clinical trial NCT05966740: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital Acquired Thrombosis consortium
First posted: 2023-08-01
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of clinically relevant bleeding events
timeFrame: Up to week 52
Secondary outcomes:
measure: Occurrence of recurrent Venous Thromboembolic Event (VTE)
timeFrame: Up to week 52
measure: Mortality related to thrombotic or thromboembolic events
timeFrame: Up to week 52
measure: Occurence of all bleeding events
timeFrame: Up to week 52
measure: Occurrence of post-thrombotic syndrome (PTS)
timeFrame: Up to week 52
measure: Incidence of adverse events (AEs)
timeFrame: Up to week 52
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to week 52
measure: Thrombotic burden at the end of the treatment period vs baseline, i.e. image-based resolution status of the thrombus (complete response, partial response, stable disease, progressive disease)
timeFrame: Baseline and up to week 12
measure: Recurrence of VTE while on treatment
timeFrame: Up to week 52
measure: Duration of treatment with dabigatran etexilate
timeFrame: Up to week 52
measure: Compliance with dabigatran etexilate treatment
timeFrame: Up to week 52
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Indianapolis
country: United States
facility: Indiana Hemophilia & Thrombrosis Center
state: Indiana
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Dayton
country: United States
facility: Dayton Children's Hospital
state: Ohio
city: Charleston
country: United States
facility: MUSC (Medical university of South Carolina)
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Austin
country: United States
facility: Dell Children's Ascension
state: Texas
Study officials:
References: