Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage
- Conditions
- Intracerebral Hemorrhage
- Interventions
- Other: Standard management for ICH
- Registration Number
- NCT03741530
- Lead Sponsor
- Xijing Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glibenclamide group Glibenclamide Tablets 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. Glibenclamide group Standard management for ICH 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. Control group Standard management for ICH Giving standard management for ICH
- Primary Outcome Measures
Name Time Method The proportion of death or major disability 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).
- Secondary Outcome Measures
Name Time Method National Institute of Health stroke scale 7 days after onset The National Institutes of Health Stroke Scale (NIHSS) is used by healthcare providers to evaluate the impairment caused by stroke. The total score of the scale runs from 0 to 42. The higher score is an indicative of more severe impairment.
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 Barthel Index scale is used to measure performance in activities of daily living (ADL). The total score of the scale runs from 0 to 100. The high score of the scale represents favourable performance in activities of daily life.
The proportion of death or major disability 7 days after 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).
Glasgow Coma Scale 7 days after onset The Glasgow Coma Scale is a scale for measuring the conscious state of patients with neurological diseases. The total score of the scale runs from 3 (deep coma or death) to 15 (fully awake person).
The change in the volume of PHE from the initial to follow-up CT scans 7 days after onset
Trial Locations
- Locations (5)
Ankang Central Hospital
🇨🇳Ankang, Shaanxi, China
Hanzhong Central Hospital
🇨🇳Hanzhong, Shaanxi, China
Xianyang Central Hospital
🇨🇳Xianyang, Shaanxi, China
Xijing Hospital
🇨🇳Xi'an, Shaanxi, China
Tangdu Hospital
🇨🇳Xi'an, Shaanxi, China