A pilot study of neuroprotective effect of granulocyte colony-stimulating factor (G-CSF) in patients with carbon monoxide poisoning: a double-blind, randomized, placebo-controlled trial.

Although neuroprotective effects of granulocyte colony-stimulating factor (G-CSF) have been shown in rats exposed to carbon monoxide (CO), this pilot clinical trial was performed to assess the feasibility of treatment with G-CSF in patients with acute CO poisoning. A double-blind, randomized, placebo-controlled pilot clinical trial was conducted on twenty-six patients with acute CO poisoning. G-CSF (90 μg/kg) was administered intravenously for 72 h. Demographic data, routine laboratory tests, differential blood counts, venous blood gas, and adverse reactions were recorded. The primary endpoint was brain ischemia improvement based on CT findings and the secondary endpoints examined improvements in the modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), and Barthel Index as well as S-100β concentrations. Fourteen patients received G-CSF, and 12 received a placebo. Twenty-six were followed for 30 days and no one in both groups died during follow-up. Neurological complications, brain ischemic changes, Barthel, and mRS were compared between the two groups on determined days after the onset of therapeutic intervention, and no significant differences were observed between the two groups. Favorable results were achieved for treated patients by different measures; NIHSS was decreased 72 h after treatment (p = 0.046), and S-100β levels were significantly higher in the G-CSF group than in the control group, 12 h and 72 h after the treatment. G-CSF appears to have potential effects on several clinical parameters in patients with acute CO poisoning. The trial was registered at the Iranian Registry of Clinical Trials with the ID: (IRCT201607232083N7).