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Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: A randomised, controlled, phase 3 trial

The Lancet Haematology Nov 20, 2019

Male C, Lensing AWA, Palumbo JS, et al. - Researchers performed this multicentre, parallel-group, open-label, randomized study, to compare rivaroxaban vs standard anticoagulants, in terms of efficacy and safety in children with venous thromboembolism. Participants were children (aged 0–17 years) visiting 107 paediatric hospitals in 28 countries with documented acute venous thromboembolism who had commenced heparinisation. They allocated (2:1) the participants to bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20-mg equivalent dose or standard anticoagulants (heparin or switched to vitamin K antagonist). The stratification of the randomization was done by age and venous thromboembolism site. Findings revealed that rivaroxaban treatment vs standard anticoagulants led to similarly low recurrence risk and decreased thrombotic burden without increased bleeding in children with acute venous thromboembolism.
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