cerebral apoplexy
Conditions
Interventions
Test group:Edaravone right camphor injection (5 ml: edaravone 10 mg: right camphor 2.5 mg): 15 ml dissolved in 0.9% normal saline 250 ml, q12h
control group:0.9% normal saline 250 ml, q12h
Course of treatment: 7 d
Sponsors
Gulou Hospital Affiliated to Medical College of Nanjing University
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 45-80 year, gender unlimited; 2. Patients with acute middle cerebral artery occlusion (M1 or M2 segment) within 24 hours received emergency intravascular treatment and successfully recovered blood flow, with a mtici score of 2B or above; 3. CTP results were consistent with core infarct volume 10 ml, and the mismatch between ischemic penumbra volume and infarct volume reached 20%; 4. NIHSS score 6-26 points; 5. Sign the informed consent form; 6. Those who can independently engage in activities of daily living before the onset of this stroke (MRS score before the onset is 0-1).
Exclusion criteria
Exclusion criteria: 1. Previous history of intracranial hemorrhage; Have a history of severe head injury, stroke or myocardial infarction within 3 months before screening; 2. Accompanied by intracranial tumors and giant intracranial aneurysms; 3. Currently accompanied by active visceral hemorrhage; Or arterial puncture at the part that is not easy to compress and stop bleeding within 1 week before screening; Or gastrointestinal or urinary bleeding occurred within 3 weeks before screening; 4. With aortic arch dissection; 5. Patients with severe primary liver and kidney diseases, AST or ALT greater than 2 times the upper limit of normal, serum creatinine > 2.0 mg/dl or > 176.8 umoL/L; 6. Major surgery was performed within 2 weeks before screening; Or had intracranial or intraspinal surgery within 3 months before screening; 7. Acute bleeding quality, including but not limited to: platelet count 1.7 or PT > 15 seconds; Direct thrombin inhibitor or direct factor Xa inhibitor is being used, and sensitive laboratory indicators are increased (such as APTT, INR, platelet count and snake vein enzyme coagulation time (ECT); Thrombin time (TT); Or appropriate factor Xa determination); 8. Serious cardiopulmonary disease, the researchers think it is not suitable to participate in this study; 9. After active antihypertensive treatment, hypertension has not been controlled: systolic blood pressure >= 180 mmHg, or diastolic blood pressure >= 100 mmHg; 10. Blood glucose 22.22 mmol/L; 11. CT showed multiple lobar infarction (low density range > 1/3 cerebral hemisphere); 12. Suffering from other diseases of the central nervous system; 13. Patients with severe mental disorders and dementia; 14. Allergic to edaravone, (+) -2-camphenol or excipients; 15. Patients during pregnancy, lactation and planned pregnancy; 16. Patients with malignant tumors, or patients whose life expectancy is less than 3 months, or patients who cannot complete the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with 0-2 mrs 0 points after 90 days of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of National Institutes of Health Stroke Scale (NIHSS) score improved by 4 points on the 7th day of cerebral infarction;Secretion of peripheral inflammatory factors: 24 h and 3-7 d after cerebral infarction;Proportion of subjects with mrs 0-1 score 90 days after treatment;Symptomatic intracranial hemorrhage rate 1 day after reperfusion; | — |
Countries
China
Contacts
Public ContactQingxiu Zhang
Gulou Hospital Affiliated to Medical College of Nanjing University
Outcome results
None listed