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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS8179 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS8179 | Drug | HRS8179 injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The change between baseline and 72-78 hours in midline shift measured by MRI or CT | Baseline up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) Score | Day 90 | |
| Overall survival | Baseline up to Day 90 | |
| Number of Participants Who Achieved mRS 0-4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D001929 | Brain Edema |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Drug |
physiological saline |
|
| Day 90 |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Day 90 |