Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): a Multi-center Randomized, Controlled, Assessor-blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 5
- 主要终点
- The proportion of death or major disability
研究概览
简要总结
The purpose of the present study is to explore the efficacy of small doses of oral glibenclamide on brain edema after acute primary intracerebral hemorrhage (ICH), and improving the prognosis of patients.
详细描述
In order to explore the efficacy and safety of oral glibenclamide on brain edema after acute primary ICH, a web-based 1:1 randomization process will be employed to assign 220 subjects to Glibenclamide group (giving standard management for ICH plus glibenclamide) or Control group (giving standard management for ICH). The investigators will make a neurofunctional assessment at baseline, and 3 days, 7 days, 90 days after enrollment. The investigators also assess the midline shift, and the change in the volume of ICH and perihematomal edema (PHE) from the initial to follow-up (3 days and 7days after enrollment). The serious adverse events of all-cause mortality, cardiac-related and blood glucose-related adverse events will be collected to assess the safety of glibenclamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years with a primary ICH
- •A baseline CT with basal ganglia hemorrhage of 5 to 30 mL
- •Glasgow Coma Scale (GCS) score ≥ 6
- •Symptom onset less than 72 hours prior to admission
- •Informed consent
排除标准
- •Supratentorial ICH planned to evacuation of a large hematoma
- •Hemorrhage breaking into ventricles of brain
- •Prior significant disability (mRS ≥ 3)
- •Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR <30ml/min/1.73m2
- •Severe liver disorder, or ALT >3 times or bilirubin >2 times upper limit of normal
- •Blood glucose < 55 mg/dL (3.1 mmol/L）at enrollment, or with the history of hypoglycemia
- •With acute ST elevation infarction, or decompensated heart failure, or cardiac arrest, or acute coronary syndrome, or known history of admission for acute coronary syndrome, or acute myocardial infarction, or coronary intervention in the past 3 months
- •Treatment with sulfonylurea in the past 7 days, including glyburide, glyburide plus metformin, glimepiride, repaglinide, glipizide, gliclazide, tolbutamide and glibornuride
- •Treatment with bosentan in the past 7 days
- •Be allergic to sulfa or other sulfonylurea drugs
- •Known G6PD deficiency
- •Pregnant women
- •Breast-feeding women disagreeing to participate the study or stop breastfeeding during and after the study
- •Be enrolled in other non-observation-only study with receiving an investigational drug
- •Life expectancy <3 months due to other diseases rather than current ICH
- •Refusing to be enrolled, or having poor compliance, or tending to withdraw
研究组 & 干预措施
Glibenclamide group
Giving standard management for ICH plus glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.
干预措施: Glibenclamide Tablets (Drug)
Glibenclamide group
Giving standard management for ICH plus glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.
干预措施: Standard management for ICH (Other)
Control group
Giving standard management for ICH
干预措施: Standard management for ICH (Other)
结局指标
主要结局
The proportion of death or major disability
时间窗: 90 days after the onset
Unfavourable outcome including death and disability is defined as patients achieving modified Rankin Scale (mRS) ≥3. The mRS is used for measuring the degree of disability or dependence in the daily activities of patients with stroke or other neurological diseases. The total score of the scale runs from 0 (perfect health without symptoms) to 6 (death).
次要结局
- National Institute of Health stroke scale(7 days after onset)
- The change in the volume of ICH from the initial to follow-up CT scans(7 days after onset)
- Barthel Index(90 days after onset)
- The change in the volume of PHE from the initial to follow-up CT scans(7 days after onset)
- The proportion of death or major disability(7 days after onset)
- Glasgow Coma Scale(7 days after onset)