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.

Abstract

This study investigated effects of oral glibenclamide on brain contusion volume and functional outcome of patients with moderate and severe traumatic brain injuries. 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. 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. Oral glibenclamide is associated with decreased contusion expansion rate in patients with moderate and severe traumatic brain injuries sustaining cerebral contusions.