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This is a prospective, multicenter, randomized controlled clinical study aimed at evaluating the efficacy of butylphthalide in improving the severity of cerebral edema and prognosis in patients with acute anterior circulation large vessel occlusion after endovascular treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Butylphthalide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butylphthalide | Drug | For patients in the butylphthalide group, Butylphthalide and Sodium Chloride Injection was administered immediately after randomization, 100 ml per dose, intravenously, twice daily, for at least 7 days, continuing until discharge or day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Delta cerebrospinal fluid | Change from baseline in cerebrospinal fluid | 72hours after the stroke onset |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracranial hemorrhage | Symptomatic intracranial hemorrhage associated with neurological deterioration (increase in NIHSS ≥4 points) confirmed by CT or MRI. | 72hours after the stroke onset |
| NWU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaibin Huang, PhD | Contact | +86 15915751065 | hkb@smu.edu.cn | |
| Suyue Pan, PhD | Contact | +86 02062787648 | pansuyue@smu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan People's Hospital | Dongguan | Guangdong | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001929 | Brain Edema |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C027125 | 3-n-butylphthalide |
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| Placebo | Drug | For patients in the placebo group, Placebo Injection was administered immediately after randomization, 100 ml per dose, intravenously, twice daily, for at least 7 days, continuing until discharge or day 14. |
|
Net water uptake assessed by CT
| 72hours after the stroke onset |
| CED grade | Cerebral edema grade assessed by CT | 72hours after the stroke onset |
| rHV | Relative hemispheric volume ratio assessed by CT | 72hours after the stroke onset |
| Malignant cerebral edema | Defined as the presence of cerebral edema with mass effect on cranial CT or MRI within 48 to 96 hours after symptom onset, including midline shift ≥ 5 mm and/or compression of ventricles or cisterns. | 48 to 96 hours after onset |
| Midline shift distance | Maximum distance of midline shift (in millimeters) measured on axial CT or MRI. | 72 to 96 hours after onset |
| Early neurological deterioration | Defined as an increase of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS; range 0-42, with higher scores indicating worse outcome) within 7 days post-treatment. | Within 7 days post-treatment |
| Decompressive craniectomy | The subject underwent decompressive craniectomy due to clinical necessity. | Within 7 days post-treatment |
| Infarct volume | Infarct volume assessed by computed tomography (CT) or magnetic resonance imaging (MR) | 48-96hours after the stroke onset |
| Modified Rankin Scale of 0 to 2 points | Modified Rankin Scale (mRS; range 0-6, with higher scores indicating worse outcome) score of 0 to 2 points. | 90 days after the stroke onset |
| Distribution of modified Rankin Scale (mRS) scores | Shift analysis of mRS scores at 90 days (range 0-6). | 90 days after the stroke onset |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
|
| The Fourth Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
|
| Heyuan People's Hospital | Heyuan | Guangdong | China |
|
| Qingyuan People's Hospital | Qingyuan | Guangdong | China |
|
| Yuebei People's Hospital | Shaoguan | Guangdong | China |
|
| Haikou People's Hospital | Haikou | Hainan | China |
|
| Hainan Provincial Hospital of Traditional Chinese Medicine | Haikou | Hainan | China |
|
| The Second Affiliated Hospital of Hainan Medical University | Haikou | Hainan | China |
| Ganzhou People's Hospital | Ganzhou | Jiangxi | China |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |