Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded Trial

Jingjing Zhao, Fang Yang, Changgeng Song, Li Li, Xiai Yang, Xiaofeng Wang, Liping Yu, Jun Guo, Kangjun Wang, Feng Fu, Wen Jiang, Jingjing Zhao, Fang Yang, Changgeng Song, Li Li, Xiai Yang, Xiaofeng Wang, Liping Yu, Jun Guo, Kangjun Wang, Feng Fu, Wen Jiang

Abstract

Introduction: Brain edema after acute intracerebral hemorrhage (ICH) plays a critical role in the secondary injury of ICH and may heighten the potential for a poor outcome. This trial aims to explore the efficacy of small doses of oral glibenclamide in perihematomal edema (PHE) and the prognosis of patients with ICH. Methods and Analysis: The GATE-ICH trial is a multicenter randomized, controlled, assessor-blinded trial. A total of 220 adult patients with acute primary ICH in 28 study centers in China will be randomized to the glibenclamide group (glibenclamide plus guideline-recommended ICH management) or the control group (guideline-recommended ICH management). Multivariate logistic regression will be used to analyze the relationship between the treatments and primary outcome. Study Outcomes: The primary efficacy outcome is the proportion of poor functional outcomes (modified Rankin Scale ≥3) at 90 days after enrollment. The secondary efficacy outcomes include changes in the volume of ICH and PHE between the baseline and follow-up computed tomography scans as well as the clinical scores between the baseline and follow-up assessments. Discussion: The GATE-ICH trial will assess the effects of small doses of oral glibenclamide in reducing the PHE after ICH and improving the 90-day prognosis of patients. Clinical Trial Registration: www.clinicaltrials.gov., NCT03741530. Registered on November 8, 2018. Trial Status: Protocol version: May 6, 2019, Version 5. Recruitment and follow-up of patients is currently ongoing. This trial will be end in the second quarter of 2021.

Keywords: clinical trial; glibenclamide; intracerebral hemorrhage; perihematomal edema; prognosis.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Zhao, Yang, Song, Li, Yang, Wang, Yu, Guo, Wang, Fu and Jiang.

Figures

Figure 1
Figure 1
Flowchart of the trial design.
Figure 2
Figure 2
Measurements of hematoma and PHE using 3D slicer software package. (A) original image of a patient with ICH. (B) hematoma marked with pink. (C) PHE marked with blue. ICH, intracerebral hemorrhage; PHE, perihematomal edema.

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Source: PubMed

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