Y-3 Injection Through Skull Bone Marrow in the Treatment of Acute Malignant Middle Cerebral Artery Infarction (SOLUTION)

Korábbi kezelés

• Concurrent with one of the other cerebrovascular diseases of the following conditions:
  • A.Acute cerebral hemorrhage or subarachnoid hemorrhage B. Acute posterior circulation infarction C.Other types of TOAST classification such as intracranial artery dissection, vasculitis and moyamoya disease

Más betegség

• Resistant hypertension (systolic> 200mmHg or diastolic> 110mmHg) or hypotension (systolic <70mmHg or diastolic <50mmHg)
• Severe cardiac insufficiency before randomization (compliance with New York College of Cardiology (NYHA) Cardiac Function Class III, IV)
• Combining with contraindications for intra-diplo administration, such as skull fracture, skull infection, subdural / external hematoma, subscalp hematoma, scalp skin or subcutaneous infection, etc
• Combining with respiratory failure, and still difficult to correct after endotracheal intubation or tracheotomy, requiring ventilator treatment
• Combining with severe CNS degenerative disease, such as AD, PD and severe dementia from various causes
• Combining with other organic diseases, such as malignancy, the patient's life expectancy is less than 3 months
• Allergy to any component of the therapeutic drug

Laborértékek

• Abnormal blood glycemia before randomization (random venous blood glucose <2.8 mmol/L or> 23 mmol/L)
• Severe hepatic or renal insufficiency (Note: severe hepatic insufficiency refers to the ALT> 3 times the upper limit of normal or the AST > 3 times the upper limit of normal; severe renal insufficiency means the creatinine value> 1.5 times the upper limit of normal or GFR <40 ml/min/1.73m2)
• Bleeding tendency (including but not limited to): platelet count <100×109 / L; received heparin within nearly 24h, APTT ≥35s; oral warfarin, INR>1.7; new-oral-anticoagulant orally; with direct thrombin or factor Xa inhibitor; Combining with coagulopathy such as hemophilia
• presence of severe or very severe anemia (hemoglobin <60g / L)

Egyéb

• Hemorrhagic transformation in the infarct area, over 30% of the infarct area, and significant occupancy effect
• Bilateral pupil fixation / pupillary reflex disappeared
• Decompressive craniectomy was planned before randomization
• Dual antiplatelet (aspirin plus clopidogrel or ticagrelor or cilostazol) within 24 hours or tirofiban within 4 hours
• Other neuroprotective agents without guideline recommendations and with unknown mechanism of the most important component were used within 24 hours of onset
• Patients with pregnancy, lactation, or a possible pregnancy and a planned pregnancy
• Unable to comply with the trial protocol or follow-up requirements
• Other circumstances deemed unsuitable by investigator
• Also participate in other interventional clinical trials

• 1.18-75 years old; 2.No gender limitation; 3.Pre-stroke mRS score <2 4. Randomization can be finished within 24 hours of stroke onset (onset time is defined as last-seen-well time) 5. Ischemic stroke in the middle cerebral artery(MCA) territory meeting the following characteristics: A. 15<NIHSS≤30 B. Imaging within 6h of onset indicated the core area of infarction (rCBF<30% volume in CTP)>1/2 MCA territory or ASPECTS score≤6 6.If endovascular-reperfusion therapy is performed, the treatment is not effective with one of the following conditions: A. The NIHSS score decreased≤4 and the total score was still>15 B. The NIHSS score progressed immediately after the therapy and the total score≤30 7. Informed consent signed