Effects of Oral Glibenclamide on Brain Contusion Volume and Functional Outcome of Patients with Moderate and Severe Traumatic Brain Injuries: A Randomized Double-Blind Placebo-Controlled Clinical Trial

OBJECTIVE: This study investigated effects of oral glibenclamide on brain contusion volume and functional outcome of patients with moderate and severe traumatic brain injuries. METHODS: A randomized clinical trial including 66 patients with moderate (Glasgow Coma Scale score 9-12) to severe (Glasgow Coma Scale score 5-8) traumatic brain injury and brain contusions of <30 mL volume was conducted from May 2015 to August 2016 in a Level I trauma center in southern Iran. Patients who required surgical intervention were excluded. Patients were randomly assigned to receive 10 mg oral glibenclamide daily for 10 days (n = 29) or placebo in the same dosage (n = 23). Brain contusion volumetry was performed on days 0, 3, and 7 using spiral thin-cut brain computed tomography scan (1-mm thickness). Outcome measures including modified Rankin Scale, Glasgow Outcome Scale, and Disability Rating Scale were evaluated 3 months after injury. RESULTS: There was no significant difference between the 2 study groups in baseline, day 3, and day 7 contusion volumes. Patients receiving glibenclamide had a significantly lower expansion ratio from first to second volumetry (P < 0.001). Similarly, the first to third expansion ratio was significantly lower in the glibenclamide group compared with placebo (P = 0.003). There was no significant difference between the 2 groups regarding functional outcome measured by Glasgow Outcome Scale, modified Rankin Scale, and Disability Rating Scale. CONCLUSIONS: Oral glibenclamide is associated with decreased contusion expansion rate in patients with moderate and severe traumatic brain injuries sustaining cerebral contusions.