Intracerebral Hemorrhage
Conditions
Keywords
Intracerebral hemorrhage, Perihematomal edema, Disability, Clinical trial
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.
Interventions
Giving glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.
OTHERStandard management for ICH
Usual care and drug in hospital
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The change in the volume of PHE from the initial to follow-up CT scans | 3 days after onset | — |
| The change in the volume of ICH from the initial to follow-up CT scans | 3 days after onset | — |
| The proportion of death or major disability | 3 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). |
| National Institute of Health stroke scale | 3 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. |
| Glasgow Coma Scale | 3 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). |
| Barthel Index | 3 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cardiac-related Adverse Events and Serious Adverse Events | 7 days after admission | — |
| Incidence of all-cause mortality | 90 days after onset | — |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | During hospitalization | — |
| Incidence of symptomatic hypoglycemia | 7 days after admission | Blood glucose \<3.1 mmol/L with investigator-identified hypoglycemic symptoms |
| Incidence of hypoglycemia | 7 days after admission | Blood glucose \<3.1 mmol/L |
Countries
China
Outcome results
None listed