Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial

Autor: Jacqueline Halton, Leonardo R Brandão, Matteo Luciani, Lisa Bomgaars, Elizabeth Chalmers, Lesley G Mitchell, Ildar Nurmeev, Anjali Sharathkumar, Pavel Svirin, Kirill Gorbatikov, Igor Tartakovsky, Monika Simetzberger, Fenglei Huang, Zhichao Sun, Jörg Kreuzer, Savion Gropper, Paul Reilly, Martina Brueckmann, Manuela Albisetti, Asiya Safina, Ondrej Zapletal, Tomas Kuhn, Tomas Votava, Judy Felgenhauer, Ali Amid, Paola Saracco, Csongor Kiss, Susan Halimeh, Madlen Reschke, Beate Wulff, Michele David, Zbynek Novak, Inna Trunina, Tony Frisk, Heidi Glosli, Andreas Groll, Olga Lvova, Ilgen Sasmaz, Darintr Sosothikul, Virginija Zilinskaite, Erin Cockrell, Valeriy Digtyar, Ivana Hadacova, Sauli Palmu, Anjali Pawar, Joyce Maria Annichino Bizzacchi, Umran Caliskan, Tiraje Celkan, Dmytro Dmytriiev, Colleen Harkins Druzgal, Graciela Onelda Elena, Antonis Kattamis, Ramazan Kaan Kavakli, Christoph Male, Nihal Ozdemir, An Van Damme, Tatiana Zvereva, Aanen Aarli, Rogelio Alejandro Paredes Aguilera, Selin Aytac, Jorge Carneiro, Antonio Chistolini, Maria Gabriela Mazzucconi, Fernando Corrales-Medina, Francis Couturaud, Stacey E Croteau, Cameron Trenor III, Michael Damgaard, Natalia Dixon, Anna Galustyan, Jiri Hak, Marianne Hoffmann, Alphan Kupesiz, Veerle Labarque, Christel van Geet, Ming-Chih Lin, Yun-Ching Fu, Sandra Loggetto, Veerle Mondelaers, Irena Odri-Komazec, Shoshana Revel-Vilk, Julian Sevilla, Luciano Fuzzato Silva, José Kerr Saraiva, Fernando Felix Montes Tapia, Wendy Woods-Swafford
Přispěvatelé: UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service d'hématologie et d'oncologie pédiatrique
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: The Lancet. Haematology, Vol. 8, no.1, p. e22-e33 (2021)
Popis: BACKGROUND: 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. METHODS: DIVERSITY is a randomised, controlled, open-label, parallel-group, phase 2b/3 non-inferiority trial done in 65 centres in 26 countries. Standard of care (low-molecular-weight heparins, unfractionated heparin, vitamin K antagonists or fondaparinux) was compared with a paediatric oral dabigatran dosing regimen (an age-adjusted and weight-adjusted nomogram) in children younger than 18 years with acute venous thromboembolism initially treated (5-21 days) with parenteral anticoagulation, requiring anticoagulation therapy for at least 3 months. Patients were randomised 1:2 (standard of care:dabigatran) and stratified by age (12 to
Databáze: OpenAIRE