Severe Cerebral Edema Following Large Hemispheric Infarction
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, and safety of HRS8179 injection in preventing and treating severe cerebral edema after large area cerebral infarction in the cerebral hemisphere
Interventions
DRUGHRS8179 injection
HRS8179 injection; high dose
DRUGHRS8179 blank preparation.
HRS8179 blank preparation.
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
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
1. Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative); 2. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory; 3. National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening; 4. A large hemispheric infarction defined as: lesion volume of 80 to 160 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP). 5. The time from onset to treatment must be ≤ 10 hours; if the onset time is unknown, treatment must be initiated within 10 hours after the time last known normal.
Exclusion criteria
1. Theparticipant is likely to withdraw the supportive treatment on the first day; 2. There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome. 3. There are clinical signs of brain herniation; CT/MRI indicates a midline shift of \>2 mm; CT/MRI indicates cerebral hemorrhage;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality rate at Day 90 | at Day 90 |
Secondary
| Measure | Time frame |
|---|---|
| The modified Rankin Scale (mRS) score at Day 90 | at Day 90 |
| The proportion of participants who achieved mRS score 0-4 at Day 90 | at Day 90 |
| Changes in midline shift from baseline to 72 hours | from baseline to 72 hours |
| The proportion of participants who meet the indications for decompressive craniectomy by Day 14 | Day 14 |
Countries
China
Contacts
Primary ContactYu Gao
Outcome results
None listed