Safety and efficacy of edaravone for patients with acute stroke: A protocol for randomized clinical trial

BACKGROUND: We performed a randomized clinical trial protocol to assess the effectiveness of edaravone for acute stroke. We hypothesized that edaravone is beneficial in improving neurological impairment resulting from acute stroke. METHOD: The protocol was reviewed and approved by the Research Ethics Board of Affiliated Hospital of Chengde Medical University (0092-2394), each participant signed a written consent before participating, and SPIRIT guidelines were followed throughout. The inclusion criteria for patients were as follows: diagnosed as acute stroke (ischemic stroke or intracerebral hemorrhage) by head CT or MRI within 72 hours; age greater than 18; motor function disorder; Glasgow Coma Scale greater than 12. Patients with the following symptoms were excluded: concurrent serious complications, such as coma, drug allergy, mental disorder, and other severe organic lesions in the brain. Sixty patients were finally included in the study. The control group accepted conventional treatment, while the treatment group received edaravone treatment on top of the conventional treatment of the control group. After treatment, the differences in functional movement, living ability score, neurological score, treatment effect, and adverse reaction of these 2 groups were tested and compared. DISCUSSION: As aging worsens, the incidence of acute stroke continues to increase. Brain damage will induce the production of oxygen radicals, which can damage the cytomembrane of brain cells and finally damage the nervous system and cause cerebral injury as well as the cerebral edema. Edaravone is an antioxidant and oxygen radical scavenger that can inhibit lipid peroxidation during the scavenging of oxygen free radicals. Besides, it can also elicit anti-inflammatory protective effects for nerve cells, increase cerebral blood flow volume, prevent the aggravation of cerebral hypoperfusion toward necrosis, reduce nerve damage, and improve neurological functions and prognosis. This is the first randomized controlled trial to assess the efficacy of edaravone for treating acute stroke. High quality, large sample size, multicenter randomized trials are still required. TRIAL REGISTRATION: researchregistry6492.