acute large hemispheric infarction
Conditions
Interventions
ICO injection group:RK-4 ICO injection through intracalvariosseous injection device (drilling 3 holes (each for 1-time administration) from the outer cranial plate without penetrating the inner plate)
standard treatment group:standard treatment and management according to the related guidelines
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18=6; b. Imaging suggestive of core infarct area: apparent diffusion coefficient (ADC) values <620×10^-6mm^2/s lesion volume on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequences or cerebral blood flow (CBF) <30% of volume 70-300 ml on computed tomography perfusion imaging (CTP) or an Alberta Stroke Program Early CT Score (ASPECTS) of 0-6, with inconsistent findings, the investigator is required to make a reasoned judgement by taking into account all the information (scanning time, the imaging method that best responds to the size of infarct, etc.) and record it. 5. NIHSS score not improving or progressing after reperfusion therapy and total score still <=32. 6. Informed consent signed.
Exclusion criteria
Exclusion criteria: 1. Complications with other cerebrovascular diseases meet one of the following conditions: a. Complicated with acute cerebral hemorrhage and subarachnoid hemorrhage; b. Complicated with acute posterior circulation cerebral infarction or severe posterior circulation stenosis (>70%); c. Imaging suggests that the area of cerebral infarction is involved bilaterally; d. The cause of the TOAST classification was considered as intracranial artery dissection, vasculitis, moyamoya disease and other etiological types. 2. Hemorrhage transformation in the infarction area, hematoma area >=30% of the infarction area, and has obvious space-occupying effect; 3. Presence of clinical signs of brain herniation formation, e.g., unilateral or bilateral pupil dilation and fixation; cerebral oedema-associated loss of consciousness (NIHSS 1a > 2 points), or other loss of brainstem reflexes in the judgement of the investigator, caused by cerebral oedema or cerebral herniation formation; or other signs of instability of vital signs that are difficult to control; 4. Craniotomy decompression was planned before randomization; 5. Refractory hypertension (systolic > 200mmHg or diastolic > 110mmHg) or hypotension (systolic 23mmol/L); 7. Presence of significant abnormal liver function markers or renal function markers prior to randomization; Note: Severe liver function abnormalities were defined as serum alanine aminotransferase (ALT), or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN). Significant renal insufficiency is defined as eGFR less than 60 mL/min/1.73 m^2 (eGFR, calculated using the CKD-EPI formula) 8. Acute ST-elevation myocardial infarction (MI) and/or decompensated heart failure (meeting the New York College of Cardiology (NYHA) Heart function grades III and IV) within the past 3 months; 9. Presence of contraindications to intracalvariosseous injection, e.g., skull fracture in the last 3 months, skull infection, subdural/extradural hematoma, subcutaneous hematoma, skin or subcutaneous infection of the scalp, poorly displayed skull bone marrow niches; 10. Bleeding tendencies considered by the investigators to be detrimental to the procedure include, but are not limited to, platelet counts < 100×10^9/L, and the presence of clotting disorders such as hemophilia; 11. Presence of severe or very severe anemia (hemoglobin <60 g/L) at randomization; 12. Patients with severe respiratory diseases (severe chronic obstructive pulmonary disease, respiratory failure, etc.) should be corrected by intubation, tracheotomy, or ventilator; 13. The subjects were considered to have developed clinically significant serious infections, including severe local infections or systemic infections; 14. Diagnosed severe degenerative diseases of the central nervous system such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and severe dementia of all causes, or psychiatric disorders (e.g., schizophrenia, depression, etc.); 15. Subjects with a life expectancy of less than 3 months due to conditions not considered current by the investigators, such as tumors; 16. Known allergy to any component of investigational process therapy drugs and contrast agents; 17. Subjects who are pregnant, breastfeeding or have the possibility of becoming pregnant or plan to become preg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failed of drilling;Number of drug-leakage events;Patients' tolerance of therapy;Failed for other reasons;Rate of participants with infection events;Rate of intracranial hemorrhage;Rate of bleeding;Rate of hepatic insufficiency;Rate of severe renal insufficiency;Severe or extremely severe anaemia;Mortality;Adverse events / serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of GCS scores from baseline;Change of the NIHSS scores from baseline;90 days functional improvement;180 days functional improvement; | — |
Countries
China
Contacts
Public ContactYilong Wang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed