Albumin: 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.
Endovascular treatment: Best endovascular treatment.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 18 and 80 years;
2. Acute ischemic stroke with indications for endovascular treatment within 24 hours of onset;
3. Anterior circulation acute ischemic stroke, with acute occlusion of the responsible vessel located in the intracranial segment of the internal carotid artery, or the M1 or M2 segment of the middle cerebral artery;
4. National Institute of Health Stroke Scale (NIHSS) score \>=6;
5. Alberta Stroke Program Early CT Score (ASPECTS) \>=3 points;
6. Modified Rankin Scale (mRS) score ≤4 before onset of the disease;
7. Written informed consent provided by the patients or their legal relatives.
Exclusion Criteria:
1. Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan;
2. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc;
3. Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
4. Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
5. Pregnancy, breastfeeding;
6. An episode or exacerbation of congestive heart failure from any cause in the past 6 months;
7. History of heart valve disease complicated by congestive heart failure within the past 6 months;
8. Cardiac surgery with thoracotomy (eg. coronary artery bypass grafting or valve replacement surgery) within the past 6 months;
9. Acute myocardial infarction in the past 6 months;
10. Signs or symptoms of acute myocardial infarction upon admission, including electrocardiographic findings;
11. Elevated serum troponin concentration upon admission (\>0.1 μg/L) ;
12. Acute arrhythmia (including any tachycardia or bradycardia) with hemodynamic instability (systolic blood pressure \<100 mm Hg) upon admission;
13. Acute or chronic lung diseases requiring long-term or intermittent oxygen therapy;
14. Findings on physical examination of any of the following abnormalities: (1) Jugular venous distension (jugular venous pulsation \>4 cm above the sternal angle); (2) Resting tachycardia due to congestive heart failure (heart rate \> 100 per/min); (3) Third heart sound; (4) Abnormal hepatic jugular venous reflux; (5) Pitting edema of the lower extremities attributable to congestive heart failure or without apparent cause; (6) Rales in both lungs; (7) Or evidence of pulmonary edema, pleural effusion, or pulmonary vascular redistribution on chest X-ray;
15. Severe chronic anemia (hemoglobin \< 75 g/L);
16. Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 60 mL/min;
17. Refractory hypertension that is difficult to control by medication (defined as systolic blood pressure \> 220 mmHg, or diastolic blood pressure \> 110 mmHg);
18. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greater than 1.5 times the upper limit of the normal value.
19. History of albumin allergy or known allergy to albumin;
20. Patients with severe mental disorders or dementia who are unable to cooperate in completing informed consent and follow-up content;
21. The expected survival time is less than 90 days (such as comorbidity with malignant tumor or severe systemic diseases etc.);
22. Patients who have participated in other interventional clinical studies within 30 days before randomization or are currently participating in other interventional clinical studies.
23. The investigator believes that the subject has other conditions making it unsuitable for participating in this study.
Primary outcome measure(s)
Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4) at 90 days. — 90 days Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)
Trial sites (56)
Facility
City
Region
Status
Susong County Hospital of Traditional Chinese Medicine
Anqing
Anhui
Recruiting
Bozhou People's Hospital
Bozhou
Anhui
Recruiting
Taihe County Hospital of Traditional Chinese Medicine
Fuyang
Anhui
Recruiting
Ma'anshan People's Hospital
Ma’anshan
Anhui
Recruiting
Si County People's Hospital
Suzhou
Anhui
Recruiting
Wuwei People's Hospital
Wuhu
Anhui
Recruiting
Wuhu Second People's Hospital
Wuhu
Anhui
Recruiting
Xuanwu Hospital,Capital Medical University
Beijing
Beijing Municipality
Recruiting
Fujian Medical University Union Hospital
Fuzhou
Fujian
Recruiting
Zhangzhou Hospital
Zhangzhou
Fujian
Recruiting
Shanghai General Hospital Jiujuan Hospital
Jiuquan
Gansu
Recruiting
PLA Joint Logistic Support Force 940th Hospital
Lanzhou
Gansu
Recruiting
Gansu Provincial Hospital
Lanzhou
Gansu
Recruiting
Sanshui Hospital of Zhujiang Hospital, Southern Medical University
Foshan
Guangdong
Recruiting
Heyuan People's Hospital
Heyuan
Guangdong
Recruiting
Huazhou People's Hospital
Huazhou
Guangdong
Recruiting
Huiyang Sanhe Hospital
Huizhou
Guangdong
Recruiting
Luoding People's Hospital
Luoyang
Guangdong
Recruiting
Cenxi People's Hospital
Cenxi
Guangxi
Recruiting
Guiyang Fourth People's Hospital
Guiyang
Guizhou
Recruiting
Baoding No. 1 Central Hospital
Baoding
Hebei
Recruiting
Kailuan General Hospital Linxi Hospital
Tangshan
Hebei
Recruiting
Jiamusi University Hongda Hospital
Jiamusi
Heilongjiang
Recruiting
Jixi People's Hospital
Jixi
Heilongjiang
Recruiting
Luoyang Central Hospital
Luoyang
Henan
Recruiting
Pingdingshan Second People's Hospital
Pingdingshan
Henan
Recruiting
Ningling County People's Hospital
Shangqiu
Henan
Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Weihui
Henan
Recruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou
Henan
Recruiting
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou
Henan
Not Yet Recruiting
Zhongmou County People's Hospital
Zhengzhou
Henan
Recruiting
Zhoukou Central Hospital
Zhoukou
Henan
Recruiting
Shenqiu County People's Hospital
Zhoukou
Henan
Recruiting
Xihua County People's Hospital
Zhoukou
Henan
Recruiting
Taihe Hospital, Hubei University of Medicine
Shiyan
Hubei
Recruiting
Tianmen First People's Hospital
Tianmen
Hubei
Recruiting
Changde First People's Hospital
Changde
Hunan
Recruiting
Liuyang Jili Hospital
Guankou
Hunan
Recruiting
The First Affiliated Hospital of Shaoyang University
Shaoyang
Hunan
Recruiting
Yiyang Central Hospital
Yiyang
Hunan
Recruiting
+ 16 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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