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Rivaroxaban Compared with Standard Anticoagulants for the Treatment of Acute Venous Thromboembolism in Children: a Randomised, Controlled, Phase 3 Trial

  • Male, C.
  • Lensing, A. W. A.
  • Palumbo, J. S.
  • Kumar, R.
  • Nurmeev, I.
  • Hege, K.
  • Bonnet, D.
  • Connor, P.
  • Hooimeijer, H. L.
  • Torres, M.
  • Chan, A. K. C.
  • Kenet, G.
  • Holzhauer, S.
  • Santamaría, A.
  • Amedro, P.
  • Chalmers, E.
  • Simioni, P.
  • Bhat, R. V.
  • Yee, D. L.
  • Lvova, O.
  • Beyer-Westendorf, J.
  • Biss, T. T.
  • Martinelli, I.
  • Saracco, P.
  • Peters, M.
  • Kállay, K.
  • Gauger, C. A.
  • Massicotte, M. P.
  • Young, G.
  • Pap, A. F.
  • Majumder, M.
  • Smith, W. T.
  • Heubach, J. F.
  • Berkowitz, S. D.
  • Thelen, K.
  • Kubitza, D.
  • Crowther, M.
  • Prins, M. H.
  • Monagle, P.
  • Molinari, A. C.
  • Nowak, Göttl, U.
  • Chain, J.
  • Robertson, J.
  • Thom, K.
  • Streif, W.
  • Schwarz, R.
  • Schmitt, K.
  • Grangl, G.
  • Van Damme, A.
  • Maes, P.
  • Labarque, V.
  • Petrilli, A.
  • Loggeto, S.
  • Azeka, E.
  • Brandao, L.
  • Le, D.
  • Sabapathy, C.
  • Giordano, P.
  • Wu, R.
  • Ding, J.
  • Huang, W.
  • Mao, J.
  • Lähteenmäki, P.
  • Decramer, S.
  • Bernig, T.
  • Chada, M.
  • Chan, G.
  • Kally, K.
  • Nolan, B.
  • Revel-Vilk, S.
  • Tamary, H.
  • Levin, C.
  • Tormene, D.
  • Abbattista, M.
  • Artoni, A.
  • Ikeyama, T.
  • Inuzuka, R.
  • Yasukochi, S.
  • Morales Soto, M.
  • Solis Labastida, K. A.
  • Suijker, M. H.
  • Bartels, M.
  • Tamminga, R. Y.
  • Van Ommen, C. H.
  • Te Loo, D. M.
  • Anjos, R.
  • Zubarovskaya, L.
  • Popova, N.
  • Samochatova, E.
  • Belogurova, M.
  • Svirin, P.
  • Shutova, T.
  • Lebedev, V.
  • Barbarash, O.
  • Koh, P. L.
  • Mei, J. C.
  • Podracka, L.
  • Berrueco, R.
  • Fernandez, M. F.
  • Frisk, T.
  • Grunt, S.
  • Rischewski, J.
  • Albisetti-Pedroni, M.
  • Antmen, A.
  • Tokgoz, H.
  • Karakas, Z.
  • Motwani, J.
  • Williams, M.
  • Grainger, J.
  • Payne, J.
  • Richards, M.
  • Baird, S.
  • Bhatnagar, N.
  • Aramburo, A.
  • Crary, S.
  • Wynn, T.
  • Carpenter, S.
  • Ahuja, S.
  • Goldenberg, N.
  • Woods, G.
  • Godder, K.
  • Scott-Emuakpor, A.
  • Roach, G.
  • Raffini, L.
  • Shah, N.
  • Shah, S.
  • Thornburg, C.
  • Zia, A.
  • Berkow, R.
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Publication date
January 2020
Publisher
Elsevier BV
Journal
The Lancet Haematology

Abstract

Background: Treatment of venous thromboembolism in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. The aim of our study was to compare the efficacy and safety of rivaroxaban versus standard anticoagulants in children with venous thromboembolism. Methods: In a multicentre, parallel-group, open-label, randomised study, children (aged 0–17 years) attending 107 paediatric hospitals in 28 countries with documented acute venous thromboembolism who had started heparinisation were assigned (2:1) to bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20-mg equivalent dose or standard anticoagulants (heparin or switched to vitamin K antagonist). Randomisation was stratifie...

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