Intracerebral Hemorrhage
Conditions
Brief summary
pending
Interventions
Edaravone Dexborneol 37.5 mg, containing Edaravone 30 mg and Dexborneol 7.5 mg, Edaravone Dexborneol 37.5 mg BID, 14 days, addition to standard of care of Intracerebral Hemorrhage
DRUGPlacebo
Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1 | 90 days after the first dose of study treatment |
Secondary
| Measure | Time frame |
|---|---|
| The proportionof Participants With modified Rankin Scale (mRS) | 14, 30 and 90 days after the first dose of study treatment |
| The change in the NIH stroke scale (NIHSS) from the baseline | 14, 30 and 90 days after the first dose of study treatment |
| The proportion of death | 90 days after the first dose of study treatment |
| Barthel Index (BI) | 90 days after the first dose of study treatment |
| Stroke Specific Quality of Life Scale (SS-QOL) | 90 days after the first dose of study treatment |
| The proportionof Participants With Glasgow Outcome Score (GOS) | 14, 30 and 90 days after the first dose of study treatment |
Contacts
Primary ContactXiaofei Feng, MD
Backup ContactXiaofei Feng, MD
Outcome results
None listed