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.
Parallel
RK-4 ICO injection
DevicePatients included will be given skull outer plate drilling surgery and RK-4 ICO injection under local anesthesia and sedation using the intracalvariosseous injection device. The drilling and injection will be conducted once a day for 3 consecutive days.
Conventional treatment
Other interventionstandard treatment and management according to related guidelines
Failed of drilling
The rate of the internal plate of skull was drilled through
Number of drug-leakage events
Number of drug-leakage events
Patients' tolerance of therapy
The number of patients who refused to continue the treatment because of the intolerance
Failed for other reasons
Number of failed for other reasons
Change of GCS scores from baseline
The Glasgow Coma Scale (GCS) score is a validated and reliable scale to evaluate level of consciousness in patients. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst).
Change of the NIHSS scores from baseline
Change of the National Institutes of Health Stroke Scale (NIHSS) scores from baseline to 14±1days or at discharge. The 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.
90 days functional improvement
The modified Rankin Scale 0-3 points at 90±7 days. Functional improvement is defined as a dichotomized modified Rankin Scale(mRS) 0-3 outcome. The 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
180 days functional improvement
The modified Rankin Scale 0-3 points at 180±14 days. Functional improvement is defined as a dichotomized modified Rankin Scale(mRS) 0-3 outcome. The 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
Click on the lead sponsor to view all of their trials.
yilong Wang
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
