Y-3 Injection Through Skull Bone Marrow in the Treatment of Acute Malignant Middle Cerebral Artery Infarction (SOLUTION)
Stroke, Acute Ischemic
About this trial
This is an interventional treatment trial for Stroke, Acute Ischemic focused on measuring malignant middle cerebral artery infarction, Y-3, postsynaptic density protein 95 inhibitor, BBB-bypassing route, brain drug delivery, Intracalvaria bone marrow injection
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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 Resistant hypertension (systolic> 200mmHg or diastolic> 110mmHg) or hypotension (systolic <70mmHg or diastolic <50mmHg) 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) Severe cardiac insufficiency before randomization (compliance with New York College of Cardiology (NYHA) Cardiac Function Class III, IV) Dual antiplatelet (aspirin plus clopidogrel or ticagrelor or cilostazol) within 24 hours or tirofiban within 4 hours Combining with contraindications for intra-diplo administration, such as skull fracture, skull infection, subdural / external hematoma, subscalp hematoma, scalp skin or subcutaneous infection, etc 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) 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 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
Sites / Locations
- Beijing Tiantan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Intracalvaria bone marrow injection group
Conventional treatment group
Y-3 ,Intracalvaria bone marrow injection , continuous medication for 3 days, with standard treatment and management according to the related guidelines.
standard treatment and management according to related guidelines