| Autor: |
Ohmori H; Department of Pediatrics, National Hospital Organization Yanai Medical Center.; Clinical Research Center, National Hospital Organization Nagoya Medical Center., Nakamura M; Department of Cardiology and Nephrology, Mie University Graduate School of Medicine., Kada A; Clinical Research Center, National Hospital Organization Nagoya Medical Center., Saito AM; Clinical Research Center, National Hospital Organization Nagoya Medical Center., Sanayama Y; Department of Pediatrics, National Hospital Organization Shimoshizu Hospital., Shinagawa T; Department of Pediatrics, National Hospital Organization Aomori Hospital., Fujita H; Department of Pediatrics, National Hospital Organization Aomori Hospital., Wakisaka A; Department of Pediatrics, National Hospital Organization Iou Hospital., Maruhashi K; Department of Pediatrics, National Hospital Organization Iou Hospital., Okumura A; Department of Pediatrics, National Hospital Organization Toyama Hospital., Takizawa N; Department of Pediatrics, National Hospital Organization Toyama Hospital., Murata H; Department of Pediatrics, National Hospital Organization Mie Hospital., Inoue M; Department of Pediatrics, National Hospital Organization Minami-Okayama Medical Center., Kaneko H; Department of Clinical Research, National Hospital Organization Nagara Medical Center., Taniguchi H; Department of Pediatric Neurosurgery, National Hospital Organization Shikoku Medical Center for Children and Adults., Kawasaki M; Department of Respiratory Medicine, National Hospital Organization Omuta Hospital., Sano N; Department of Pediatrics, National Hospital Organization Minami-Kyushu Hospital., Akaboshi S; Department of Pediatrics, National Hospital Organization Tottori Medical Center., Tanuma N; Department of Pediatrics, Tokyo Metropolitan Fuchu Medical Center for the Disabled., Sone S; Department of Pediatrics, Tokyo Metropolitan Higashiyamato Medical Center for Developmental/Multiple Disabilities., Kumode M; Department of Pediatrics, Biwako Gakuen Kusatsu Medical and Welfare Center., Takechi T; Department of Pediatrics, National Hospital Organization Kochi Hospital., Koretsune Y; Director General, National Hospital Organization Osaka National Hospital., Sumimoto R; Department of Surgery, National Hospital Organization Yanai Medical Center., Miyanomae T; Department of Pediatrics, National Hospital Organization Minami Kyoto Hospital. |
| Abstrakt: |
Sudden death in patients with severe motor and intellectual disabilities (SMID) is sometimes caused in part by pulmonary thromboembolism (PTE), and deep venous thrombosis (DVT) has drawn attention as a possible embolic source. Warfarin, which is a conventional therapeutic agent, is not easy to control appropriately, and daily management can be especially difficult in SMID patients. On the other hand, edoxaban tosilate hydrate, which has been newly approved for insurance coverage for the treatment of DVT, is not listed in the Guidelines for the Diagnosis, Treatment and Prevention of Pulmonary Thromboembolism and Deep Vein Thrombosis (DVT-PTE guidelines). The aim of this study is to evaluate the efficacy and safety of anticoagulation therapy (warfarin vs. edoxaban) in DVT treatment in SMID patients by means of an open-label, randomized controlled trial. The primary endpoint is the incidence of hemorrhagic events during 12 months of follow up. |
