Intracerebral Hemorrhage
Conditions
Interventions
Experimental group1:Androtriol Injection, 30 mL per time (5 mL per ampoule, i.e., 6 ampoules per time), intravenous drip, every 12 hours, drip completed in 30 minutes, administered continuously for 7
Experimental group2:Androtriol Injection 10ml, Hydroxypropyl Beta-Cyclodextrin Injection 20ml, 30 mL per time (5 mL per ampoule, that is 6 ampoules per time), intravenous drip, every 12 hours, drip co
Placebo:Hydroxypropyl beta-cyclodextrin injection, 30 mL per dose (5 mL per ampoule, i.e., 6 ampoules per dose), intravenous infusion, every 12 hours, infused over 30 minutes, administered continuousl
Sponsors
Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18~80 years, male or female; 2.Hematoma volume > 30 mL and =9 on admission; 8.NIHSS>=6 on admission; 9.Voluntarily signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1.History of traumatic intracerebral hemorrhage, or subarachnoid hemorrhage within 3 months; 2.Brainstem hemorrhage; 3.Coagulation disorders; 4.History of ischemic stroke within 3 months, or complicated with cerebral infarction of onset; 5.Confirmed one of the following diseases: cerebral amyloid angiopathy, cerebral arteriovenous malformation, cerebral aneurysm, brain tumor, secondary intracerebral hemorrhage caused by thrombolytic drugs, etc.; 6.Signs of cerebral hernia; 7.Signs of prophylactic decompressive craniectomy; 8.Severe renal impairment: serum creatinine >265 µmol/L (>3 mg/dL), or estimated glomerular filtration rate (eGFR) 5 times the upper limit of normal (ULN) or total bilirubin >5 times the ULN, or obvious symptoms and signs of liver damage; 10.Dementia (e.g., Alzheimer's disease), Parkinson's disease, other neurological diseases causing cognitive or motor dysfunction, or other severe psychiatric abnormalities; 11.Complicated with terminal cancer with a life expectancy of no more than 6 months; 12.Severe injury within 3 months, or undergone major surgery within 4 weeks without full recovery; 13.Cardiovascular diseases that may affect the evaluation of safety or efficacy, such as, complete atrioventricular block, congestion heart failure (CHF), etc.; 14.History of drug, alcohol or medicine abuse; 15.Pregnant or lactating female, or male subjects who plan to impregnate their spouse during the trial period; 16.Allergy to the investigational medicine or medicines with similar chemical structures; 17.Received therapeutic hypothermia for brain protection prior to signing the Informed Consent Form (ICF); 18.Participation in other clinical trial within 3 months; 19.Unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of mRS 0-1 at 90±7 days after administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of mRS 0-2 at 90±7 days after administration;90±7 days mRS distribution;Change in volume of Perihematomal Edema ;Change in cerebral midline shift ;Changes in hematoma volume ;Changes in NIHSS scores ;Proportion in indications for decompressive craniectomy at 90 days;Rate of decompressive craniectomy at 90 days;Rate of hematoma evacuation at 90±7days; | — |
Countries
China
Contacts
Public ContactJinfang Liu
Xiangya Hospital of Central South University
Outcome results
None listed