Brain Swelling, Large Hemispheric Infarction
Conditions
Brief summary
The primary objective is to explore if HRS8179 could improve midline shift at 72 hours (or at time of decompressive craniectomy or comfort measures only, if earlier) in participants with large hemispheric infarction. The secondary objective is to explore if HRS8179 could improve acute neurologic status, functional outcomes, treatment requirements and safety.
Interventions
DRUGHRS8179
HRS8179 injection
DRUGPlacebo
physiological saline
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 research, and sign the informed consent form (the informed consent form can be signed voluntarily by the person or legal representative); 2. Aged 18\ 80, regardless of gender; 3. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory; 4. NIHSS ≥ 10 points at screening; 5. A large hemispheric infarction is defined as: lesion volume of 80 to 300 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP). 6. The study drug initiated must be no later than 10 hours when stroke onset;
Exclusion criteria
1. The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.3. There are clinical signs of brain hernia; 2. CT/MRI suggested that the anterior septal/pineal excursion was \>2 mm due to brain edema; 3. CT/MRI indicates cerebral hemorrhage (excluding small ecchymosis/punctate hemorrhage);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change between baseline and 72-78 hours in midline shift measured by MRI or CT | Baseline up to 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| modified Rankin Scale (mRS) Score | Day 90 |
| Overall survival | Baseline up to Day 90 |
| Number of Participants Who Achieved mRS 0-4 | Day 90 |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Day 90 |
Countries
China
Outcome results
None listed