Status:
UNKNOWN
Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
pending
Eligibility Criteria
Inclusion
- Written informed consent from the patient or legally acceptable representative
- Males and females
- Diagnose as hypertensive intracerebral hemorrhage
- Onset of symptoms within 6\~48 hours
- Position of bleeding major in basal ganglia
- The sum of scores on items 5 and 6 on the NIHSS were \>= 2 at baseline and the total score (items 1-11) was \>=6 and \<=20
- Volume of Hematoma \<= 30 ml
- Premorbid mRS score of 0 or 1
Exclusion
- Allergy to known study drugs or excipients
- Experienced stroke in latest 3 month
- Volume of Hematoma \> 5 ml in other bleeding position
- Obstructive hydrocephalus
- Any diagnosis as other than hypertensive ICH
- Unconsciousness
- Severe concurrent illness with life expectancy less than 90 days
- Pregnancy or breast-feeding
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT04714177
Start Date
March 1 2021
End Date
September 1 2023
Last Update
January 19 2021
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