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http://elar.urfu.ru/handle/10995/103208
Название: | Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (Einstein-Jr CVT) |
Авторы: | Connor, P. van Kammen, M. S. Lensing, A. W. A. Chalmers, E. Kállay, K. Hege, K. Simioni, P. Biss, T. Bajolle, F. Bonnet, D. Grunt, S. Kumar, R. Lvova, O. Bhat, R. van Damme, A. Palumbo, J. Santamaria, A. Saracco, P. Payne, J. Baird, S. Godder, K. Labarque, V. Male, C. Martinelli, I. Soto, M. M. Motwani, J. Shah, S. Hooimeijer, H. L. Prins, M. H. Kubitza, D. Smith, W. T. Berkowitz, S. D. Pap, A. F. Majumder, M. Monagle, P. Coutinho, J. M. EINSTEIN-Jr, Cerebral, Venous, Thrombosis, trial, investigators |
Дата публикации: | 2020 |
Издатель: | American Society of Hematology |
Библиографическое описание: | Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (Einstein-Jr CVT) / P. Connor, M. S. van Kammen, A. W. A. Lensing, et al. — DOI 10.1182/bloodadvances.2020003244 // Blood Advances. — 2020. — Vol. 4. — Iss. 24. — P. 6250-6258. |
Аннотация: | Anticoagulant treatment of pediatric cerebral venous thrombosis has not been evaluated in randomized trials. We evaluated the safety and efficacy of rivaroxaban and standard anticoagulants in the predefined subgroup of children with cerebral venous thrombosis (CVT) who participated in the EINSTEIN-Jr trial. Children with CVT were randomized (2:1), after initial heparinization, to treatment with rivaroxaban or standard anticoagulants (continued on heparin or switched to vitamin K antagonist). The main treatment period was 3 months. The primary efficacy outcome, symptomatic recurrent venous thromboembolism (VTE), and principal safety outcome, major or clinically relevant nonmajor bleeding,were centrally evaluated by blinded investigators. Sinus recanalization on repeat brain imaging was a secondary outcome. Statistical analyses were exploratory. In total, 114 children with confirmed CVT were randomized. All children completed the follow-up. None of the 73 rivaroxaban recipients and 1 (2.4%; CVT) of the 41 standard anticoagulant recipients had symptomatic, recurrent VTE after 3 months (absolute difference, 2.4%; 95% confidence interval [CI], 22.6% to 13.5%). Clinically relevant bleeding occurred in 5 (6.8%; all nonmajor and noncerebral) rivaroxaban recipients and in 1 (2.5%; major [subdural] bleeding) standard anticoagulant recipient (absolute difference, 4.4%; 95% CI, 26.7% to 13.4%). Complete or partial sinus recanalization occurred in 18 (25%) and 39 (53%) rivaroxaban recipients and in 6 (15%) and 24 (59%) standard anticoagulant recipients, respectively. In summary, in this substudy of a randomized trial with a limited sample size, children with CVT treated with rivaroxaban or standard anticoagulation had a low risk of recurrent VTE and clinically relevant bleeding. This trial was registered at clinicaltrials.gov as #NCT02234843. © 2020 by The American Society of Hematology |
Ключевые слова: | ANTIVITAMIN K FONDAPARINUX RIVAROXABAN ADOLESCENT ARTICLE BLEEDING CEREBRAL SINUS THROMBOSIS CHILD CONTROLLED STUDY DRUG EFFICACY DRUG SAFETY DRUG SUBSTITUTION DRUG WITHDRAWAL FEMALE FOLLOW UP FUNCTIONAL NEUROIMAGING HEPARINIZATION HUMAN LOW RISK POPULATION MAJOR CLINICAL STUDY MALE MULTICENTER STUDY PATIENT PARTICIPATION PHASE 3 CLINICAL TRIAL PRIORITY JOURNAL RANDOMIZED CONTROLLED TRIAL RECANALIZATION SAMPLE SIZE SCHOOL CHILD TREATMENT DURATION TREATMENT OUTCOME VENOUS THROMBOEMBOLISM |
URI: | http://elar.urfu.ru/handle/10995/103208 |
Условия доступа: | info:eu-repo/semantics/openAccess |
Идентификатор SCOPUS: | 85098051228 |
Идентификатор WOS: | 000602609500018 |
Идентификатор PURE: | 552d50c2-36ea-48f2-b2aa-0debdb0768ef 20453790 |
ISSN: | 24739529 |
DOI: | 10.1182/bloodadvances.2020003244 |
Сведения о поддержке: | This study was supported by Bayer AG and Janssen Research and Development. |
Располагается в коллекциях: | Научные публикации ученых УрФУ, проиндексированные в SCOPUS и WoS CC |
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Файл | Описание | Размер | Формат | |
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2-s2.0-85098051228.pdf | 841,26 kB | Adobe PDF | Просмотреть/Открыть |
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