A pilot study confirmed the feasibility and safety of neuroprotectant RK-4 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 investigate the feasibility and safety of neuroprotective agent RK-4 injection using intracalvariosseous injection device 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.
yilong Wang
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution