A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.
18≤Age≤80 years;
First stroke or complete self-care before the onset of current stroke (mRS 0-1);
Administration of drugs can be completed within 24h of the onset of signs and symptoms of neurological deficits (in patients with wake-up strokes or unwitnessed strokes, the time of onset is defined as the time of last normal presentation);
16≤ NIHSS ≤32 points, and the sum of the scores of motor arm and motor leg is ≥6;
Complicated with acute cerebral hemorrhage and subarachnoid hemorrhage;
Complicated with acute posterior circulation cerebral infarction or severe posterior circulation stenosis (>70%);
Or imaging suggests that the area of cerebral infarction is involved bilaterally;
The cause of the TOAST classification was considered as intracranial artery dissection, vasculitis, moyamoya disease and other etiological types.
Parallel
Y-3 ICO injection
Procedure/SurgeryPatients included will be given skull outer plate drilling surgery and Y-3 ICO injection under local anesthesia and sedation. The injection will be given for 3 consecutive days.
Y-3 intravenous injection
DrugPatients included will be given Y-3 intravenous injection for 7 consecutive days.
Conventional treatment
Other interventionstandard treatment and management according to related guidelines during the entire treatment period
90-day favorable clinical outcome
Favorable clinical outcome defined as a dichotomized mRS 0-3 outcome The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
Change of infarct volume from baseline to 8-day
The infarct volume is determined on a diffusion-weighted MRI map based on an ADC threshold of less than 620 ×10\^-6mm\^2/s or on CTP image with rCBF\<30%
Neurofunctional deficit defined as the National Institutes of Health Stroke Scale (NIHSS) .
NIHSS is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity.
Patients with symptoms improvement from baseline to 14-day
Symptoms improvement defined as the NIHSS scores improved by 4 points from baseline to 14-day
Rate of decompressive hemicraniectomy
Rate of decompressive hemicraniectomy
1-year favorable clinical outcome
Favorable clinical outcome defined as a dichotomized mRS 0-3 outcome The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
1-year modified Rankin Scale
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
1-year anterior circulation Alberta Stroke Program Early CT Score
Alberta Stroke Program Early CT Score（ASPECTS）, a scale from 0-10 to measure infarct size, with lower scores reflecting larger infarcts
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yilong Wang
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
