Acute large hemispheric infarction
Conditions
Interventions
Trial group :Drill a hole through the outer table of the skull to the diplo? without penetrating the inner table. Administer 1 mL of RK-4 injection (with a concentration of 2 mg/mL) once a day by inje
Control group:Provide active standardized treatment according to the latest guidelines.
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 81 Years
Inclusion criteria
Inclusion criteria: 1. The age is required to be greater than or equal to 18 years old and less than 81 years old, with no gender limitation. 2. The modified Rankin Scale (mRS) score before the onset of this episode should be less than or equal to 1 point. 3. The drug can be administered within 24 hours after the appearance of symptoms and signs of neurological deficits (for subjects with wake-up stroke or unwitnessed stroke, the time when the patient was last known to be normal shall be regarded as the onset time of symptoms). 4. The clinical symptoms, signs and imaging diagnosis indicate cerebral infarction in the blood supply area of the middle cerebral artery, and the following characteristics should be met simultaneously: (1) The National Institutes of Health Stroke Scale (NIHSS) score should be greater than or equal to 16 points and less than or equal to 32 points, and the sum of the scores for item 5 (upper limb) and item 6 (lower limb) should be greater than or equal to 6 points. (2) Imaging suggests that for the infarct core area: the volume of the lesion with cerebral blood flow (CBF) less than 30% in computed tomography perfusion imaging (CTP) or the volume of the lesion with an apparent diffusion coefficient (ADC) value less than 620 × 10^-6mm^2/s in the diffusion-weighted imaging (DWI) sequence of magnetic resonance imaging (MRI) is between 70 ml and 300 ml, or the Alberta Stroke Program Early CT Score (ASPECTS) is between 0 and 6 points. The results of CTP examination shall be given priority. If both CTP and DWI are completed during the screening period and the examination results are inconsistent, the investigator shall comprehensively consider all information (scanning time, imaging methods that best reflect the size of the infarct, etc.) to make a reasonable judgment and record it. The ASPECTS score can be based on either CTP or MRI, but CTP shall be given priority. 5. If vascular reperfusion treatment has been carried out and the treatment effect is poor, the following conditions should be met simultaneously: (1) The expanded Thrombolysis in Cerebral Infarction (eTICI) grade is equal to 2a. (2) The NIHSS score has not improved or has progressed after vascular reperfusion treatment, and the total score is still less than or equal to 32 points. Note: A reduction of 1 point or more is considered as improvement, and an increase of 1 point or more is considered as progress. 6. The subject or his/her legal representative voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Concurrent with other cerebrovascular diseases that meet one of the following conditions: (1) Combined with acute intracerebral hemorrhage or subarachnoid hemorrhage; (2) Combined with posterior circulation cerebral infarction in the acute phase, or severe stenosis of the posterior circulation vessels (> 70%); (3) Or imaging suggests that the cerebral infarction area involves both sides; (4) Before screening, the cause has been clearly diagnosed as other etiological types such as intracranial artery dissection, vasculitis, or moyamoya disease through TOAST classification. 2. Hemorrhagic transformation in the infarct area, with the hematoma area being greater than or equal to 30% of the infarct area and having a significant mass effect. 3. The presence of clinical signs of herniation, for example, dilation and fixation of the unilateral or bilateral pupils; loss of consciousness related to cerebral edema (National Institutes of Health Stroke Scale item 1a > 2 points), or loss of other brainstem reflexes judged by the investigator to be caused by cerebral edema or herniation; or other signs of unstable vital signs that are difficult to control. 4. Planned craniectomy for decompression at the time of screening. 5. Refractory hypertension that is difficult to control with drugs (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg) or hypotension (systolic blood pressure 23 mmol/L). 7. The presence of significant abnormal liver function indicators or significant abnormal renal function indicators.Note: Significant abnormal liver function indicators refer to serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) being greater than 3 times the upper limit of the normal range (ULN); significant abnormal renal function indicators refer to estimated glomerular filtration rate (eGFR) 38.5 °C) caused by infection, increased heart rate, chills, disturbance of consciousness, dyspnea, shock, etc. 14. Diagnosed severe central nervous system (CNS) degenera
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with an mRS score of 0-3 on the 90 +/- 7th day of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in NIHSS score on the 8th day with a margin of plus or minus 1 day compared to the baseline during the treatment.;The proportion of patients with an improvement in NIHSS score of >=4 points compared to the baseline on the 14th day with a margin of plus or minus 1 day of treatment.;The change in NIHSS score on the 14th day with a margin of plus or minus 1 day compared to the baseline during treatment.;Comparison of the distribution of mRS scores on the 90th day with a margin of plus or minus 7 days of treatment.;The proportion of patients undergoing decompressive craniectomy within 90 +/- 7 days of treatment.;The proportion of combined adverse events (mRS score of 4-5, decompressive craniectomy, and vascular death) within 90 +/- 7 days of treatment.; | — |
Countries
China
Contacts
Public ContactWang Yilong
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed