1. Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial
- Author
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Halton, Jacqueline, Brandão, Leonardo R, Luciani, Matteo, Bomgaars, Lisa, Chalmers, Elizabeth, Mitchell, Lesley G, Nurmeev, Ildar, Sharathkumar, Anjali, Svirin, Pavel, Gorbatikov, Kirill, Tartakovsky, Igor, Simetzberger, Monika, Huang, Fenglei, Sun, Zhichao, Kreuzer, Jörg, Gropper, Savion, Reilly, Paul, Brueckmann, Martina, Albisetti, Manuela, Nurmeev, Ildar, Safina, Asiya, Zapletal, Ondrej, Brandão, Leonardo R, Kuhn, Tomas, Votava, Tomas, Felgenhauer, Judy, Sharathkumar, Anjali, Svirin, Pavel, Amid, Ali, Halton, Jacqueline, Gorbatikov, Kirill, Saracco, Paola, Kiss, Csongor, Halimeh, Susan, Reschke, Madlen, Wulff, Beate, David, Michele, Novak, Zbynek, Trunina, Inna, Albisetti, Manuela, Frisk, Tony, Glosli, Heidi, Groll, Andreas, Lvova, Olga, Sasmaz, Ilgen, Sosothikul, Darintr, Zilinskaite, Virginija, Cockrell, Erin, Digtyar, Valeriy, Hadacova, Ivana, Palmu, Sauli, Pawar, Anjali, Annichino Bizzacchi, Joyce Maria, Caliskan, Umran, Celkan, Tiraje, Dmytriiev, Dmytro, Druzgal, Colleen Harkins, Onelda Elena, Graciela, Kattamis, Antonis, Kavakli, Ramazan Kaan, Male, Christoph, Ozdemir, Nihal, Van Damme, An, Zvereva, Tatiana, Aarli, Aanen, Paredes Aguilera, Rogelio Alejandro, Aytac, Selin, Carneiro, Jorge, Chistolini, Antonio, Mazzucconi, Maria Gabriela, Corrales-Medina, Fernando, Couturaud, Francis, Croteau, Stacey E, Trenor III, Cameron, Damgaard, Michael, Dixon, Natalia, Galustyan, Anna, Hak, Jiri, Hoffmann, Marianne, Kupesiz, Alphan, Labarque, Veerle, van Geet, Christel, Lin, Ming-Chih, Fu, Yun-Ching, Loggetto, Sandra, Mondelaers, Veerle, Odri-Komazec, Irena, Revel-Vilk, Shoshana, Sevilla, Julian, Fuzzato Silva, Luciano, Kerr Saraiva, José, Montes Tapia, Fernando Felix, and Woods-Swafford, Wendy
- Abstract
Dabigatran etexilate is a direct oral anticoagulant with potential to overcome the limitations of standard of care in children with venous thromboembolism. The aims of this clinical trial were to study the appropriateness of a paediatric dabigatran dosing algorithm, and the efficacy and safety of dabigatran dosed according to that algorithm versus standard of care in treating children with venous thromboembolism.
- Published
- 2021
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