Phase 3 single‐arm multicenter study of dabigatran etexilate for secondary prevention of venous thromboembolism in children: Rationale and design

摘要

BackgroundAnticoagulant therapy for venous thromboembolism (VTE) in children is largely based on treatment recommendations for adults. However, differences in both physiology (ie, renal maturation and drug excretion) and developmental hemostasis must be considered when treating children, as such differences could affect dose appropriateness, safety and efficacy.