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.