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

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN ETEXILATE
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AE07) dabigatran etexilate

  dabigatran etexilate
• Additional medical condition(s):
  Venous Thromboembolism

Population studied

• Short description of the 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.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)

Study design details

• Outcomes:
  Primary Outcome: ; -Cumulative incidence of clinically relevant bleeding events; Secondary Outcomes:; -Occurrence of recurrent Venous Thromboembolic Event (VTE); -Mortality related to thrombotic or thromboembolic events; -Occurence of all bleeding events; -Occurrence of post-thrombotic syndrome (PTS); -Incidence of adverse events (AEs); -Incidence of serious adverse events (SAEs); -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); -Recurrence of VTE while on treatment; -Duration of treatment with dabigatran etexilate; -Compliance with dabigatran etexilate treatment