Dabigatran versus Warfarin for the Treatment of Pediatric Thromboembolism: A Pilot Randomized Trial

Background: Venous thromboembolism (VTE) is still a problematic situation in children. Drugs like warfarin, enoxaparin, and heparin are current standard of care in childhood VTE. This study was designed to compare the efficacy of warfarin with dabigatran etexilate in children with VTE. Methods: This randomized and active-controlled study was done in Amir-Kabir Hospital, Arak, Iran. Twenty-five children aged between 6 and 18 years with VTE were included. Study subjects were randomized 1:1 to enoxaparin 1 mg/kg twice daily and daily 0.2 mg/kg warfarin or enoxaparin 1 mg/kg twice daily and dabigatran etexilate twice daily. Enoxaparin therapy was continued for 5 days. Treatment with warfarin and dabigatran continued for 6 months. Patients were monitored for minor and major bleeding events, thrombus extension or recurrence, and death. Results: A total of 23 patients presented with deep-vein thrombosis completed the study and followed up over the course of 6 months. Dabigatran had similar effects to warfarin with respect to the thrombus cure, which occurred in 10 patients in the dabigatran group (90 %) and 9 patients in the warfarin group (81%). There were no differences in the frequency of bleeds, either major or minor (P > 0.05). GI upset was the most common side effects seen in both groups, and the differences were significant (P < 0.05). Conclusion: Our study suggests that a 6-month treatment with dabigatran and warfarin had similar effects in secondary prevention of VTE in children < 18 yr. Dabigatran therapy was associated with more gastrointestinal upset.