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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
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.
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.
Dongguan People's Hospital
Dongguan, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Fourth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Delta cerebrospinal fluid
Change from baseline in cerebrospinal fluid
Time frame: 72hours after the stroke onset
Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage associated with neurological deterioration (increase in NIHSS ≥4 points) confirmed by CT or MRI.
Time frame: 72hours after the stroke onset
NWU
Net water uptake assessed by CT
Time frame: 72hours after the stroke onset
CED grade
Cerebral edema grade assessed by CT
Time frame: 72hours after the stroke onset
rHV
Relative hemispheric volume ratio assessed by CT
Time frame: 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.
Time frame: 48 to 96 hours after onset
Midline shift distance
Maximum distance of midline shift (in millimeters) measured on axial CT or MRI.
Time frame: 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.
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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
Time frame: Within 7 days post-treatment
Decompressive craniectomy
The subject underwent decompressive craniectomy due to clinical necessity.
Time frame: Within 7 days post-treatment
Infarct volume
Infarct volume assessed by computed tomography (CT) or magnetic resonance imaging (MR)
Time frame: 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.
Time frame: 90 days after the stroke onset
Distribution of modified Rankin Scale (mRS) scores
Shift analysis of mRS scores at 90 days (range 0-6).
Time frame: 90 days after the stroke onset