Design and rationale for the DIVERSITY study: An open‐label, randomized study of dabigatran etexilate for pediatric venous thromboembolism
| Autor: | Igor Tartakovsky, Manuela Albisetti, Martina Brueckmann, Lesley G. Mitchell, Ivan Manastirski, Lisa Bomgaars, Savion Gropper, Matteo Luciani, Jacqueline Halton, Branislav Biss, Fenglei Huang, Bushi Wang, Elizabeth Chalmers, Leonardo R. Brandão, Ruth Harper |
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| Přispěvatelé: | University of Zurich |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
anticoagulants pediatrics venous thromboembolism 610 Medicine & health 030204 cardiovascular system & hematology law.invention Dabigatran 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Patient age law medicine Dosing cardiovascular diseases Thrombus business.industry Hematology Heparin medicine.disease dabigatran etexilate direct thrombin inhibitors 10036 Medical Clinic 030220 oncology & carcinogenesis Emergency medicine Original Article Open label business Venous thromboembolism Original Articles: Thrombosis medicine.drug |
| Zdroj: | Research and Practice in Thrombosis and Haemostasis |
| ISSN: | 2475-0379 |
| Popis: | Essentials Current standard of care (SOC) for pediatric venous thromboembolism (VTE) has limitations.Dabigatran etexilate (DE) versus SOC will be studied in children with VTE in a phase IIb/III trial.A dosing algorithm for DE in children will be assessed guiding dosing.Valuable data on the safety and efficacy of DE for VTE in children will be obtained. Background The current standard of care (SOC) for pediatric venous thromboembolism (VTE) comprises unfractionated heparin (UFH), or low‐molecular‐weight heparin (LMWH) followed by LMWH or vitamin K antagonists, all of which have limitations. Dabigatran etexilate (DE) has demonstrated efficacy and safety for adult VTE and has the potential to overcome some of the limitations of the current SOC. Pediatric trials are needed to establish dosing in children and to confirm that results obtained in adults are applicable in the pediatric setting. Objectives To describe the design and rationale of a planned phase IIb/III trial that will evaluate a proposed dosing algorithm for DE and assess the safety and efficacy of DE versus SOC for pediatric VTE treatment. Patients/Methods An open‐label, randomized, parallel‐group noninferiority study will be conducted in approximately 180 patients aged 0 to |
| Databáze: | OpenAIRE |
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