Long-Term Treatment of Thrombosis with Enoxaparin in Pediatric and Adolescent Patients

Abstract

Thrombosis is a rare event in childhood and adolescence. Nevertheless, increasing numbers of invasive diagnostic and therapeutic procedures also result in increasing numbers of thromboses in pediatric cases, necessitating effective antithrombotic treatment regimens. In recent years, low-molecular-weight heparins (LMWH) in particular have been proved to be a safe and effective alternative to unfractioned heparins. However, the application of LMWH in pediatric patients has not been supported by a single controlled study so far. Furthermore, there is no official approval of these drugs for children. In this pilot study 27 children with deep venous thromboses (DVT) were treated with the LMWH enoxaparin at a dosage of 1.5 mg/kg body weight b.i.d. in neonates and infants and 1 mg/kg body weight b.i.d. in children. This dosage was lowered for prophylaxis if therapeutic success was achieved. The aim of the study was to investigate both, efficacy with respect to patency rates and safety during acute and long-term follow-up. Sufficient therapeutic success required a rapid production of anti-Xa target activity and was reached in 85% of the treated patients, who showed patency of the affected vessel at last follow-up. The mean duration of treatment with full dosage was 16.5 days, followed by prophylaxis over a mean duration of 9.8 months. Rethrombosis or adverse events including heparin-induced thrombocytopenia were not observed in any patient. In conclusion, enoxaparin provides an effective and safe alternative to unfractioned heparins in the treatment of thrombosis in infancy, childhood and adolescence.