Multicenter dose‐finding and efficacy and safety outcomes in neonates and children treated with dalteparin for acute venous thromboembolism

• Published in: Journal of thrombosis and haemostasis 2014-11, Vol.12 (11), p.1822-1825
• Main Authors: O'Brien, S. H., Kulkarni, R., Wallace, A., Hamblin, F., Burr, S., Goldenberg, N. A.
• Format: Article
• Language: English
• Subjects: Acute Disease; Adolescent; Age Factors; Anticoagulants - administration & dosage; Anticoagulants - adverse effects; Child; Child, Preschool; dalteparin; Dalteparin - administration & dosage; Dalteparin - adverse effects; Drug Administration Schedule; Drug dosages; Drug therapy; Female; Hemorrhage - chemically induced; Humans; Infant; Infant, Newborn; Injections, Subcutaneous; low molecular weight heparin; Male; Molecular weight; Patient Safety; Pediatrics; Pilot Projects; Prospective Studies; Recurrence; Risk Factors; safety; Time Factors; Treatment Outcome; United States; Venous Thromboembolism - diagnosis; Venous Thromboembolism - drug therapy; venous thrombosis
• ISSN: 1538-7933; 1538-7836; 1538-7836
• DOI: 10.1111/jth.12716

Summary Background Low molecular weight heparins (LMWHs) constitute the mainstay of anticoagulant therapy for pediatric venous thromboembolism (VTE). The safety and effectiveness of dalteparin, an LMWH, has not been established in children, and pediatric data on dalteparin for VTE are limited to one single‐center experience. Objective To establish dose‐finding (primary endpoint) and efficacy/safety outcomes (secondary endpoints) in children treated with dalteparin in a substudy of the Kids‐DOTT trial. Patients and methods A prospective multicenter trial using dalteparin subcutaneously twice daily for acute VTE in children aged ≤ 21 years was conducted under an investigator‐held Investigational New Drug application registered with the US Food and Drug Administration. Initial weight‐based dosing per protocol was as follows: infants (