Study protocol for the G-SPIRIT trial: a randomised, placebo-controlled, double-blinded phase III trial of granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury

Masao Koda; Hideki Hanaoka; Takatoshi Sato; Yasuhisa Fujii; Michiko Hanawa; Sho Takahashi; Takeo Furuya; Yasushi Ijima; Junya Saito; Mitsuhiro Kitamura; Seiji Ohtori; Yukei Matsumoto; Tetsuya Abe; Kei Watanabe; Toru Hirano; Masayuki Ohashi; Hirokazu Shoji; Tatsuki Mizouchi; Ikuko Takahashi; Norio Kawahara; Masahito Kawaguchi; Yugo Orita; Takeshi Sasamoto; Masahito Yoshioka; Masafumi Fujii; Katsutaka Yonezawa; Daisuke Soma; Hiroshi Taneichi; Daisaku Takeuchi; Satoshi Inami; Hiroshi Moridaira; Haruki Ueda; Futoshi Asano; Yosuke Shibao; Ikuo Aita; Yosuke Takeuchi; Masaya Mimura; Jun Shimbo; Yukio Someya; Sumio Ikenoue; Hiroaki Sameda; Kan Takase; Yoshikazu Ikeda; Fumitake Nakajima; Mitsuhiro Hashimoto; Tomoyuki Ozawa; Fumio Hasue; Takayuki Fujiyoshi; Koshiro Kamiya; Masahiko Watanabe; Hiroyuki Katoh; Yukihiro Matsuyama; Yu Yamamoto; Daisuke Togawa; Tomohiko Hasegawa; Sho Kobayashi; Go Yoshida; Shin Oe; Tomohiro Banno; Hideyuki Arima; Koji Akeda; Eiji Kawamoto; Hiroshi Imai; Toshihiko Sakakibara; Akihiro Sudo; Yasuo Ito; Tsuyoshi Kikuchi; Shuhei Osaki; Nobuhiro Tanaka; Kazuyoshi Nakanishi; Naosuke Kamei; Shinji Kotaka; Hideo Baba; Tsuyoshi Okudaira; Hiroaki Konishi; Takayuki Yamaguchi; Keigo Ito; Yoshito Katayama; Taro Matsumoto; Tomohiro Matsumoto; Masaru Idota; Haruo Kanno; Toshimi Aizawa; Ko Hashimoto; Toshimitsu Eto; Takehiro Sugaya; Michiharu Matsuda; Kazunari Fushimi; Satoshi Nozawa; Chizuo Iwai; Toshihiko Taguchi; Tsukasa Kanchiku; Hidenori Suzuki; Norihiro Nishida; Masahiro Funaba; Masashi Yamazaki

doi:10.1136/bmjopen-2017-019083

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Neurology

Protocol

Study protocol for the G-SPIRIT trial: a randomised, placebo-controlled, double-blinded phase III trial of granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury

Authors

Masao Koda G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, University of Tsukuba, Tsukuba City, Japan Department of Orthopedic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan PubMed articles Google scholar articles
Hideki Hanaoka G-SPIRIT Study Group, Chiba, Japan Clinical Research Center, Chiba University Hospital, Chiba, Japan PubMed articles Google scholar articles
Takatoshi Sato G-SPIRIT Study Group, Chiba, Japan Clinical Research Center, Chiba University Hospital, Chiba, Japan PubMed articles Google scholar articles
Yasuhisa Fujii G-SPIRIT Study Group, Chiba, Japan Clinical Research Center, Chiba University Hospital, Chiba, Japan PubMed articles Google scholar articles
Michiko Hanawa G-SPIRIT Study Group, Chiba, Japan Clinical Research Center, Chiba University Hospital, Chiba, Japan PubMed articles Google scholar articles
Sho Takahashi G-SPIRIT Study Group, Chiba, Japan Clinical Research Center, Chiba University Hospital, Chiba, Japan PubMed articles Google scholar articles
Takeo Furuya G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan PubMed articles Google scholar articles
Yasushi Ijima G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan PubMed articles Google scholar articles
Junya Saito G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan PubMed articles Google scholar articles
Mitsuhiro Kitamura G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan PubMed articles Google scholar articles
Seiji Ohtori Department of Orthopedic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan PubMed articles Google scholar articles
Yukei Matsumoto G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, University of Tsukuba, Tsukuba City, Japan PubMed articles Google scholar articles
Tetsuya Abe G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, University of Tsukuba, Tsukuba City, Japan PubMed articles Google scholar articles
Kei Watanabe G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Niigata University Graduate School of Medicine and Dental Sciences, Niigata, Japan PubMed articles Google scholar articles
Toru Hirano G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Niigata University Graduate School of Medicine and Dental Sciences, Niigata, Japan PubMed articles Google scholar articles
Masayuki Ohashi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Niigata University Graduate School of Medicine and Dental Sciences, Niigata, Japan PubMed articles Google scholar articles
Hirokazu Shoji G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Niigata University Graduate School of Medicine and Dental Sciences, Niigata, Japan PubMed articles Google scholar articles
Tatsuki Mizouchi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Niigata University Graduate School of Medicine and Dental Sciences, Niigata, Japan PubMed articles Google scholar articles
Ikuko Takahashi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Niigata University Graduate School of Medicine and Dental Sciences, Niigata, Japan PubMed articles Google scholar articles
Norio Kawahara G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kanazawa Medical University, Uchinada, Japan PubMed articles Google scholar articles
Masahito Kawaguchi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kanazawa Medical University, Uchinada, Japan PubMed articles Google scholar articles
Yugo Orita G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kanazawa Medical University, Uchinada, Japan PubMed articles Google scholar articles
Takeshi Sasamoto G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kanazawa Medical University, Uchinada, Japan PubMed articles Google scholar articles
Masahito Yoshioka G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kanazawa Medical University, Uchinada, Japan PubMed articles Google scholar articles
Masafumi Fujii G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kanazawa Medical University, Uchinada, Japan PubMed articles Google scholar articles
Katsutaka Yonezawa G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kanazawa Medical University, Uchinada, Japan PubMed articles Google scholar articles
Daisuke Soma G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kanazawa Medical University, Uchinada, Japan PubMed articles Google scholar articles
Hiroshi Taneichi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Dokkyo Medical University, Shimotsuga-gun, Japan PubMed articles Google scholar articles
Daisaku Takeuchi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Dokkyo Medical University, Shimotsuga-gun, Japan PubMed articles Google scholar articles
Satoshi Inami G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Dokkyo Medical University, Shimotsuga-gun, Japan PubMed articles Google scholar articles
Hiroshi Moridaira G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Dokkyo Medical University, Shimotsuga-gun, Japan PubMed articles Google scholar articles
Haruki Ueda G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Dokkyo Medical University, Shimotsuga-gun, Japan PubMed articles Google scholar articles
Futoshi Asano G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Dokkyo Medical University, Shimotsuga-gun, Japan PubMed articles Google scholar articles
Yosuke Shibao G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Dokkyo Medical University, Shimotsuga-gun, Japan PubMed articles Google scholar articles
Ikuo Aita G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Tsukuba Medical Center, Tsukuba City, Japan PubMed articles Google scholar articles
Yosuke Takeuchi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Tsukuba Medical Center, Tsukuba City, Japan PubMed articles Google scholar articles
Masaya Mimura G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Funabashi Municipal Medical Center, Funabashi, Japan PubMed articles Google scholar articles
Jun Shimbo G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Funabashi Municipal Medical Center, Funabashi, Japan PubMed articles Google scholar articles
Yukio Someya G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Funabashi Municipal Medical Center, Funabashi, Japan PubMed articles Google scholar articles
Sumio Ikenoue G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Funabashi Municipal Medical Center, Funabashi, Japan PubMed articles Google scholar articles
Hiroaki Sameda G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Funabashi Municipal Medical Center, Funabashi, Japan PubMed articles Google scholar articles
Kan Takase G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Funabashi Municipal Medical Center, Funabashi, Japan PubMed articles Google scholar articles
Yoshikazu Ikeda G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chiba Rosai Hospital, Ichihara, Japan PubMed articles Google scholar articles
Fumitake Nakajima G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chiba Rosai Hospital, Ichihara, Japan PubMed articles Google scholar articles
Mitsuhiro Hashimoto G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chiba Rosai Hospital, Ichihara, Japan PubMed articles Google scholar articles
Tomoyuki Ozawa G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chiba Rosai Hospital, Ichihara, Japan PubMed articles Google scholar articles
Fumio Hasue G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kimitsu Chuo Hospital, Kisarazu, Japan PubMed articles Google scholar articles
Takayuki Fujiyoshi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kimitsu Chuo Hospital, Kisarazu, Japan PubMed articles Google scholar articles
Koshiro Kamiya G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kimitsu Chuo Hospital, Kisarazu, Japan PubMed articles Google scholar articles
Masahiko Watanabe G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Tokai University School of Medicine, Isehara, Japan PubMed articles Google scholar articles
Hiroyuki Katoh G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Tokai University School of Medicine, Isehara, Japan PubMed articles Google scholar articles
Yukihiro Matsuyama G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan PubMed articles Google scholar articles
Yu Yamamoto G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan PubMed articles Google scholar articles
Daisuke Togawa G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan PubMed articles Google scholar articles
Tomohiko Hasegawa G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan PubMed articles Google scholar articles
Sho Kobayashi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan PubMed articles Google scholar articles
Go Yoshida G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan PubMed articles Google scholar articles
Shin Oe G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan PubMed articles Google scholar articles
Tomohiro Banno G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan PubMed articles Google scholar articles
Hideyuki Arima G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan PubMed articles Google scholar articles
Koji Akeda G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Graduate School of Medicine, Mie University, Tsu, Japan PubMed articles Google scholar articles
Eiji Kawamoto G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Graduate School of Medicine, Mie University, Tsu, Japan PubMed articles Google scholar articles
Hiroshi Imai G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Graduate School of Medicine, Mie University, Tsu, Japan PubMed articles Google scholar articles
Toshihiko Sakakibara G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Graduate School of Medicine, Mie University, Tsu, Japan PubMed articles Google scholar articles
Akihiro Sudo G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Graduate School of Medicine, Mie University, Tsu, Japan PubMed articles Google scholar articles
Yasuo Ito G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kobe Red Cross Hospital, Kobe, Japan PubMed articles Google scholar articles
Tsuyoshi Kikuchi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kobe Red Cross Hospital, Kobe, Japan PubMed articles Google scholar articles
Shuhei Osaki G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Kobe Red Cross Hospital, Kobe, Japan PubMed articles Google scholar articles
Nobuhiro Tanaka G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan PubMed articles Google scholar articles
Kazuyoshi Nakanishi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan PubMed articles Google scholar articles
Naosuke Kamei G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan PubMed articles Google scholar articles
Shinji Kotaka G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan PubMed articles Google scholar articles
Hideo Baba G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Nagasaki Rosai Hospital, Sasebo, Japan PubMed articles Google scholar articles
Tsuyoshi Okudaira G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Nagasaki Rosai Hospital, Sasebo, Japan PubMed articles Google scholar articles
Hiroaki Konishi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Nagasaki Rosai Hospital, Sasebo, Japan PubMed articles Google scholar articles
Takayuki Yamaguchi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Nagasaki Rosai Hospital, Sasebo, Japan PubMed articles Google scholar articles
Keigo Ito G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chubu Rosai Hospital, Nagoya, Japan PubMed articles Google scholar articles
Yoshito Katayama G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chubu Rosai Hospital, Nagoya, Japan PubMed articles Google scholar articles
Taro Matsumoto G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chubu Rosai Hospital, Nagoya, Japan PubMed articles Google scholar articles
Tomohiro Matsumoto G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chubu Rosai Hospital, Nagoya, Japan PubMed articles Google scholar articles
Masaru Idota G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Chubu Rosai Hospital, Nagoya, Japan PubMed articles Google scholar articles
Haruo Kanno G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Tohoku University School of Medicine, Sendai, Japan PubMed articles Google scholar articles
Toshimi Aizawa G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Tohoku University School of Medicine, Sendai, Japan PubMed articles Google scholar articles
Ko Hashimoto G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Tohoku University School of Medicine, Sendai, Japan PubMed articles Google scholar articles
Toshimitsu Eto G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Tohoku University School of Medicine, Sendai, Japan PubMed articles Google scholar articles
Takehiro Sugaya G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Tohoku University School of Medicine, Sendai, Japan PubMed articles Google scholar articles
Michiharu Matsuda G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Tohoku University School of Medicine, Sendai, Japan PubMed articles Google scholar articles
Kazunari Fushimi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Gifu University School of Medicine, Gifu, Japan PubMed articles Google scholar articles
Satoshi Nozawa G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Gifu University School of Medicine, Gifu, Japan PubMed articles Google scholar articles
Chizuo Iwai G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Gifu University School of Medicine, Gifu, Japan PubMed articles Google scholar articles
Toshihiko Taguchi G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan PubMed articles Google scholar articles
Tsukasa Kanchiku G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan PubMed articles Google scholar articles
Hidenori Suzuki G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan PubMed articles Google scholar articles
Norihiro Nishida G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan PubMed articles Google scholar articles
Masahiro Funaba G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan PubMed articles Google scholar articles
Masashi Yamazaki G-SPIRIT Study Group, Chiba, Japan Department of Orthopedic Surgery, University of Tsukuba, Tsukuba City, Japan PubMed articles Google scholar articles

Correspondence to Dr Masao Koda; masaokod{at}gmail.com

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Citation

Koda M, Hanaoka H, Sato T, et al

Study protocol for the G-SPIRIT trial: a randomised, placebo-controlled, double-blinded phase III trial of granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury

BMJ Open 2018;8:e019083. doi: 10.1136/bmjopen-2017-019083

Publication history

Received August 15, 2017
Revised December 15, 2017
Accepted February 2, 2018
First published May 5, 2018.

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February 20, 2022

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© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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