The Efficacy and Safety of HRS8179 in Severe Cerebral Edema Following Large Hemispheric Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS8179 injection, HRS8179 blank preparation..
- Who it may be relevant to
- Registry conditions: Severe Cerebral Edema Following Large Hemispheric Infarction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy and Safety of Intravenous HRS8179 for the Prevention and Treatment of Severe Cerebral Edema Following Large Hemispheric Infarction: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II/III Clinical Trial
Overview
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
- Drug HRS8179 injection
HRS8179 injection; high dose - Drug HRS8179 blank preparation.
HRS8179 blank preparation.
Primary outcome measures
- Mortality rate at Day 90 [Time frame: at Day 90]
Secondary outcome measures (4)
- The modified Rankin Scale (mRS) score at Day 90 [Time frame: at Day 90]
- The proportion of participants who achieved mRS score 0-4 at Day 90 [Time frame: at Day 90]
- Changes in midline shift from baseline to 72 hours [Time frame: from baseline to 72 hours]
- The proportion of participants who meet the indications for decompressive craniectomy by Day 14 [Time frame: Day 14]
Eligibility criteria
Inclusion criteria
- 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);
- A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
- National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening;
- 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).
- 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
- Theparticipant is likely to withdraw the supportive treatment on the first day;
- There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.
- There are clinical signs of brain herniation; CT/MRI indicates a midline shift of >2 mm; CT/MRI indicates cerebral hemorrhage;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tiantan Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT06732648 · HRS8179-301