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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin combined with endovascular treatment group | Experimental | Albumin combined with recommended endovascular treatment will be applied. |
|
| Endovascular treatment group | Active Comparator | Recommended endovascular treatment will be applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4) at 90 days. | Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of mRS scores at 90 days | 90 days | |
| Proportion of patients with mRS score 0-1 at 90 days | 90 days | |
| 24h National Institutes of Health Stroke Scale (NIHSS) |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of symptomatic intracerebral hemorrhage | 7 days | |
| The incidence of newly onset atrial fibrillation within 7 days | 7 days | |
| The incidence rate of newly onset pulmonary edema or congestive heart failure within 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanjie Wu, MD | Contact | 010-83199439 | wuchuanjie@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taihe County Hospital of Traditional Chinese Medicine | Recruiting | Fuyang | Anhui | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Endovascular treatment | Procedure | Best endovascular treatment. |
|
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes. |
| 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. | 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. | 90 days |
| Proportion of Barthel Index (BI) ≥95 at 90 days | 90 days |
| 7 days |
| All-cause mortality rate at 90 days | 90 days |
| Si County People's Hospital | Recruiting | Suzhou | Anhui | China |
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| Xuanwu Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| Shanghai General Hospital Jiujuan Hospital | Recruiting | Jiuquan | Gansu | China |
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| Gansu Provincial Hospital | Recruiting | Lanzhou | Gansu | China |
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| Jixi People's Hospital | Recruiting | Jixi | Heilongjiang | China |
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| Ningling County People's Hospital | Recruiting | Shangqiu | Henan | China |
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| The First Affiliated Hospital of Xinxiang Medical University | Recruiting | Weihui | Henan | China |
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| The First Affiliated Hospital of Henan University of Chinese Medicine | Not yet recruiting | Zhengzhou | Henan | China |
| Zhongmou County People's Hospital | Recruiting | Zhengzhou | Henan | China |
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| Rizhao Hospital of Traditional Chinese Medicine | Recruiting | Rizhao | Shandong | China |
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| Laizhou People's Hospital | Recruiting | Yantai | Shandong | China |
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |