Multicenter, Open-Label, Randomized Controlled Trial of Warfarin and Edoxaban Tosilate Hydrate for the Treatment of Deep Vein Thrombosis in Persons with Severe Motor Intellectual Disabilities

HIROMITSU OHMORI; MASHIO NAKAMURA; AKIKO KADA; AKIKO M. SAITO; YOSHITAMI SANAYAMA; TOMOE SHINAGAWA; HIROSHI FUJITA; AKIKO WAKISAKA; KEIKO MARUHASHI; AKIKO OKUMURA; NOBORU TAKIZAWA; HIROAKI MURATA; MICHIKO INOUE; HIDEO KANEKO; HIDEKAZU TANIGUCHI; MASAYUKI KAWASAKI; NOZOMI SANO; SHINJIRO AKABOSHI; NAOYUKI TANUMA; SUI SONE; MASAO KUMODE; TOMOKI TAKECHI; YUKIHIRO KORETSUNE; RYO SUMIMOTO; TAKESHI MIYANOMAE

doi:10.2739/kurumemedj.MS651003

Study Protocol

Multicenter, Open-Label, Randomized Controlled Trial of Warfarin and Edoxaban Tosilate Hydrate for the Treatment of Deep Vein Thrombosis in Persons with Severe Motor Intellectual Disabilities

HIROMITSU OHMORI, MASHIO NAKAMURA, AKIKO KADA, AKIKO M. SAITO, YOSHITAMI SANAYAMA, TOMOE SHINAGAWA, HIROSHI FUJITA, AKIKO WAKISAKA, KEIKO MARUHASHI, AKIKO OKUMURA, NOBORU TAKIZAWA, HIROAKI MURATA, MICHIKO INOUE, HIDEO KANEKO, HIDEKAZU TANIGUCHI, MASAYUKI KAWASAKI, NOZOMI SANO, SHINJIRO AKABOSHI, NAOYUKI TANUMA, SUI SONE, MASAO KUMODE, TOMOKI TAKECHI, YUKIHIRO KORETSUNE, RYO SUMIMOTO, TAKESHI MIYANOMAE

Author information

HIROMITSU OHMORI
Department of Pediatrics, National Hospital Organization Yanai Medical Center
Clinical Research Center, National Hospital Organization Nagoya Medical Center
MASHIO NAKAMURA
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
AKIKO KADA
Clinical Research Center, National Hospital Organization Nagoya Medical Center
AKIKO M. SAITO
Clinical Research Center, National Hospital Organization Nagoya Medical Center
YOSHITAMI SANAYAMA
Department of Pediatrics, National Hospital Organization Shimoshizu Hospital
TOMOE SHINAGAWA
Department of Pediatrics, National Hospital Organization Aomori Hospital
HIROSHI FUJITA
Department of Pediatrics, National Hospital Organization Aomori Hospital
AKIKO WAKISAKA
Department of Pediatrics, National Hospital Organization Iou Hospital
KEIKO MARUHASHI
Department of Pediatrics, National Hospital Organization Iou Hospital
AKIKO OKUMURA
Department of Pediatrics, National Hospital Organization Toyama Hospital
NOBORU TAKIZAWA
Department of Pediatrics, National Hospital Organization Toyama Hospital
HIROAKI MURATA
Department of Pediatrics, National Hospital Organization Mie Hospital
MICHIKO INOUE
Department of Pediatrics, National Hospital Organization Minami-Okayama Medical Center
HIDEO KANEKO
Department of Clinical Research, National Hospital Organization Nagara Medical Center
HIDEKAZU TANIGUCHI
Department of Pediatric Neurosurgery, National Hospital Organization Shikoku Medical Center for Children and Adults
MASAYUKI KAWASAKI
Department of Respiratory Medicine, National Hospital Organization Omuta Hospital
NOZOMI SANO
Department of Pediatrics, National Hospital Organization Minami-Kyushu Hospital
SHINJIRO AKABOSHI
Department of Pediatrics, National Hospital Organization Tottori Medical Center
NAOYUKI TANUMA
Department of Pediatrics, Tokyo Metropolitan Fuchu Medical Center for the Disabled
SUI SONE
Department of Pediatrics, Tokyo Metropolitan Higashiyamato Medical Center for Developmental/Multiple Disabilities
MASAO KUMODE
Department of Pediatrics, Biwako Gakuen Kusatsu Medical and Welfare Center
TOMOKI TAKECHI
Department of Pediatrics, National Hospital Organization Kochi Hospital
YUKIHIRO KORETSUNE
Director General, National Hospital Organization Osaka National Hospital
RYO SUMIMOTO
Department of Surgery, National Hospital Organization Yanai Medical Center
TAKESHI MIYANOMAE
Department of Pediatrics, National Hospital Organization Minami Kyoto Hospital

Keywords: Severe motor and intellectual disabilities, deep vein thrombosis, duplex ultrasonography, edoxaban, warfarin

JOURNAL FREE ACCESS

2018 Volume 65 Issue 1 Pages 11-16

DOI https://doi.org/10.2739/kurumemedj.MS651003

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Abstract

Summary: 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.

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