PT  - JOURNAL ARTICLE
AU  - Koda, Masao
AU  - Hanaoka, Hideki
AU  - Sato, Takatoshi
AU  - Fujii, Yasuhisa
AU  - Hanawa, Michiko
AU  - Takahashi, Sho
AU  - Furuya, Takeo
AU  - Ijima, Yasushi
AU  - Saito, Junya
AU  - Kitamura, Mitsuhiro
AU  - Ohtori, Seiji
AU  - Matsumoto, Yukei
AU  - Abe, Tetsuya
AU  - Watanabe, Kei
AU  - Hirano, Toru
AU  - Ohashi, Masayuki
AU  - Shoji, Hirokazu
AU  - Mizouchi, Tatsuki
AU  - Takahashi, Ikuko
AU  - Kawahara, Norio
AU  - Kawaguchi, Masahito
AU  - Orita, Yugo
AU  - Sasamoto, Takeshi
AU  - Yoshioka, Masahito
AU  - Fujii, Masafumi
AU  - Yonezawa, Katsutaka
AU  - Soma, Daisuke
AU  - Taneichi, Hiroshi
AU  - Takeuchi, Daisaku
AU  - Inami, Satoshi
AU  - Moridaira, Hiroshi
AU  - Ueda, Haruki
AU  - Asano, Futoshi
AU  - Shibao, Yosuke
AU  - Aita, Ikuo
AU  - Takeuchi, Yosuke
AU  - Mimura, Masaya
AU  - Shimbo, Jun
AU  - Someya, Yukio
AU  - Ikenoue, Sumio
AU  - Sameda, Hiroaki
AU  - Takase, Kan
AU  - Ikeda, Yoshikazu
AU  - Nakajima, Fumitake
AU  - Hashimoto, Mitsuhiro
AU  - Ozawa, Tomoyuki
AU  - Hasue, Fumio
AU  - Fujiyoshi, Takayuki
AU  - Kamiya, Koshiro
AU  - Watanabe, Masahiko
AU  - Katoh, Hiroyuki
AU  - Matsuyama, Yukihiro
AU  - Yamamoto, Yu
AU  - Togawa, Daisuke
AU  - Hasegawa, Tomohiko
AU  - Kobayashi, Sho
AU  - Yoshida, Go
AU  - Oe, Shin
AU  - Banno, Tomohiro
AU  - Arima, Hideyuki
AU  - Akeda, Koji
AU  - Kawamoto, Eiji
AU  - Imai, Hiroshi
AU  - Sakakibara, Toshihiko
AU  - Sudo, Akihiro
AU  - Ito, Yasuo
AU  - Kikuchi, Tsuyoshi
AU  - Osaki, Shuhei
AU  - Tanaka, Nobuhiro
AU  - Nakanishi, Kazuyoshi
AU  - Kamei, Naosuke
AU  - Kotaka, Shinji
AU  - Baba, Hideo
AU  - Okudaira, Tsuyoshi
AU  - Konishi, Hiroaki
AU  - Yamaguchi, Takayuki
AU  - Ito, Keigo
AU  - Katayama, Yoshito
AU  - Matsumoto, Taro
AU  - Matsumoto, Tomohiro
AU  - Idota, Masaru
AU  - Kanno, Haruo
AU  - Aizawa, Toshimi
AU  - Hashimoto, Ko
AU  - Eto, Toshimitsu
AU  - Sugaya, Takehiro
AU  - Matsuda, Michiharu
AU  - Fushimi, Kazunari
AU  - Nozawa, Satoshi
AU  - Iwai, Chizuo
AU  - Taguchi, Toshihiko
AU  - Kanchiku, Tsukasa
AU  - Suzuki, Hidenori
AU  - Nishida, Norihiro
AU  - Funaba, Masahiro
AU  - Yamazaki, Masashi
TI  - 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
AID  - 10.1136/bmjopen-2017-019083
DP  - 2018 May 01
TA  - BMJ Open
PG  - e019083
VI  - 8
IP  - 5
4099  - http://bmjopen.bmj.com/content/8/5/e019083.short
4100  - http://bmjopen.bmj.com/content/8/5/e019083.full
SO  - BMJ Open2018 May 01; 8
AB  - Introduction Granulocyte colony-stimulating factor (G-CSF) is generally used for neutropaenia. Previous experimental studies revealed that G-CSF promoted neurological recovery after spinal cord injury (SCI). Next, we moved to early phase of clinical trials. In a phase I/IIa trial, no adverse events were observed. Next, we conducted a non-randomised, non-blinded, comparative trial, which suggested the efficacy of G-CSF for promoting neurological recovery. Based on those results, we are now performing a phase III trial.Methods and analysis The objective of this study is to evaluate the efficacy of G-CSF for acute SCI. The study design is a prospective, multicentre, randomised, double-blinded, placebo-controlled comparative study. The current trial includes cervical SCI (severity of American Spinal Injury Association (ASIA) Impairment Scale B/C) within 48 hours after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group is administered 400 µg/m2/day×5 days of G-CSF in normal saline via intravenous infusion for 5 consecutive days. The placebo group is similarly administered a placebo. Our primary endpoint is changes in ASIA motor scores from baseline to 3 months. Each group includes 44 patients (88 total patients).Ethics and dissemination The study will be conducted according to the principles of the World Medical Association Declaration of Helsinki and in accordance with the Japanese Medical Research Involving Human Subjects Act and other guidelines, regulations and Acts. Results of the clinical study will be submitted to the head of the respective clinical study site as a report after conclusion of the clinical study by the sponsor-investigator. Even if the results are not favourable despite conducting the clinical study properly, the data will be published as a paper.Trial registration number UMIN000018752.