Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage

Xijing Hospital220 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

220

Conditions

Intracerebral Hemorrhage

Interventions

Glibenclamide TabletsDRUG

Giving glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.

Standard management for ICHOTHER

Usual care and drug in hospital

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-70 years with a primary ICH 2. A baseline CT with basal ganglia hemorrhage of 5 to 30 mL 3. Glasgow Coma Scale (GCS) score ≥ 6 4. Symptom onset less than 72 hours prior to admission 5. Informed consent Exclusion Criteria: 1. Supratentorial ICH planned to evacuation of a large hematoma 2. Hemorrhage breaking into ventricles of brain 3. Prior significant disability (mRS ≥ 3) 4. Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR \<30ml/min/1.73m2 5. Severe liver disorder, or ALT \>3 times or bilirubin \>2 times upper limit of normal 6. Blood glucose \< 55 mg/dL (3.1 mmol/L）at enrollment, or with the history of hypoglycemia 7. 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 8. Treatment with sulfonylurea in the past 7 days, including glyburide, glyburide plus metformin, glimepiride, repaglinide, glipizide, gliclazide, tolbutamide and glibornuride 9. Treatment with bosentan in the past 7 days 10. Be allergic to sulfa or other sulfonylurea drugs 11. Known G6PD deficiency 12. Pregnant women 13. Breast-feeding women disagreeing to participate the study or stop breastfeeding during and after the study 14. Be enrolled in other non-observation-only study with receiving an investigational drug 15. Life expectancy \<3 months due to other diseases rather than current ICH 16. Refusing to be enrolled, or having poor compliance, or tending to withdraw

Locations (5)

Ankang Central Hospital

Ankang, Shaanxi, China

Hanzhong Central Hospital

Hanzhong, Shaanxi, China

Xijing Hospital

Xi'an, Shaanxi, China

Tangdu Hospital

Xi'an, Shaanxi, China

Xianyang Central Hospital

Outcomes

Primary Outcomes

The proportion of death or major disability

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).

Time frame: 90 days after the onset

Secondary Outcomes

The change in the volume of ICH from the initial to follow-up CT scans

Time frame: 3 days after onset

The change in the volume of PHE from the initial to follow-up CT scans

Time frame: 3 days after onset

The change in the volume of ICH from the initial to follow-up CT scans

Time frame: 7 days after onset

The change in the volume of PHE from the initial to follow-up CT scans

Time frame: 7 days after onset

The proportion of death or major disability

Time frame: 3 days after onset

National Institute of Health stroke scale

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.

Data from ClinicalTrials.gov

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