This study is a prospective, multicenter, open-label, randomized controlled clinical trial. The investigators will apply albumin to the reperfusion treatment of patients with acute ischemic stroke in the anterior circulation. This study aims to verify the efficacy and safety of albumin combined with endovascular treatment in patients with anterior circulation acute ischemic stroke.
This study investigates the application of albumin in reperfusion therapy for patients with acute ischemic stroke in the anterior circulation. Patients who met all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to either the Albumin combined with Endovascular Therapy group or the Endovascular Therapy group. All subjects in both groups received acute stroke treatment and secondary prevention therapy according to current American stroke guidelines, aside from our intervention. At baseline, subjects underwent non-contrast cranial computed tomography (CT) or magnetic resonance angiography (MRA) to identify the occlusion site and presence of hemorrhage; relevant laboratory tests and mRS, NIHSS, and ASPECTS scores were also completed. Furthermore, vital signs were recorded. A 90-day post-randomization telephone follow-up was conducted to assess patients using several quality of life scales.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,192
25% human albumin at a dose of 0.5g/kg (maximum dose 37.5g) should be administered intravenously. On the second, third, and fourth days, 25% human albumin at a dose of 0.5g/kg (maximum dose 37.5g) should be administered daily.
Best endovascular treatment.
Taihe County Hospital of Traditional Chinese Medicine
Fuyang, Anhui, China
RECRUITINGSi County People's Hospital
Suzhou, Anhui, China
RECRUITINGProportion of patients with functional independence at 90 days (mRS 0-2)
Time frame: 90 days
Distribution of mRS scores at 90 days
Time frame: 90 days
Proportion of patients with mRS score 0-1 at 90 days
Time frame: 90 days
24h National Institutes of Health Stroke Scale (NIHSS)
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
Time frame: 24 hours
National Institutes of Health Stroke Scale (NIHSS) at 7 days
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
Time frame: 7 days
EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) at 90 days
The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities,pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scoresindicating worse quality of life.
Time frame: 90 days
Proportion of Barthel Index (BI) ≥95 at 90 days
Time frame: 90 days
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Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGShanghai General Hospital Jiujuan Hospital
Jiuquan, Gansu, China
RECRUITINGGansu Provincial Hospital
Lanzhou, Gansu, China
RECRUITINGJixi People's Hospital
Jixi, Heilongjiang, China
RECRUITINGNingling County People's Hospital
Shangqiu, Henan, China
RECRUITINGThe First Affiliated Hospital of Xinxiang Medical University
Weihui, Henan, China
RECRUITINGThe First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
NOT_YET_RECRUITINGZhongmou County People's Hospital
Zhengzhou, Henan, China
RECRUITING...and 2 more locations