RECRUITING Phase 3 ClinicalTrials.gov

Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2

Sponsor: Capital Medical University • ClinicalTrials.gov ID: NCT07263308

Registry updated: 2026-10-19

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Description

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.

Interventions

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.
Endovascular treatment (Procedure)
Best endovascular treatment.

Eligibility criteria

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.

Conditions

Acute Ischemic Stroke

Locations

Susong County Hospital of Traditional Chinese Medicine — Anqing, Anhui, China
Bozhou People's Hospital — Bozhou, Anhui, China
Taihe County Hospital of Traditional Chinese Medicine — Fuyang, Anhui, China
Ma'anshan People's Hospital — Ma’anshan, Anhui, China
Si County People's Hospital — Suzhou, Anhui, China
Wuwei People's Hospital — Wuhu, Anhui, China
Wuhu Second People's Hospital — Wuhu, Anhui, China
Xuanwu Hospital，Capital Medical University — Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital — Fuzhou, Fujian, China
Zhangzhou Hospital — Zhangzhou, Fujian, China
Shanghai General Hospital Jiujuan Hospital — Jiuquan, Gansu, China
PLA Joint Logistic Support Force 940th Hospital — Lanzhou, Gansu, China
Gansu Provincial Hospital — Lanzhou, Gansu, China
Sanshui Hospital of Zhujiang Hospital, Southern Medical University — Foshan, Guangdong, China
Heyuan People's Hospital — Heyuan, Guangdong, China
Huazhou People's Hospital — Huazhou, Guangdong, China
Huiyang Sanhe Hospital — Huizhou, Guangdong, China
Luoding People's Hospital — Luoyang, Guangdong, China
Cenxi People's Hospital — Cenxi, Guangxi, China
Guiyang Fourth People's Hospital — Guiyang, Guizhou, China
Baoding No. 1 Central Hospital — Baoding, Hebei, China
Kailuan General Hospital Linxi Hospital — Tangshan, Hebei, China
Jiamusi University Hongda Hospital — Jiamusi, Heilongjiang, China
Jixi People's Hospital — Jixi, Heilongjiang, China
Luoyang Central Hospital — Luoyang, Henan, China
Pingdingshan Second People's Hospital — Pingdingshan, Henan, China
Ningling County People's Hospital — Shangqiu, Henan, China
The First Affiliated Hospital of Xinxiang Medical University — Weihui, Henan, China
Zhengzhou Central Hospital Affiliated to Zhengzhou University — Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of Chinese Medicine — Zhengzhou, Henan, China
Zhongmou County People's Hospital — Zhengzhou, Henan, China
Zhoukou Central Hospital — Zhoukou, Henan, China
Shenqiu County People's Hospital — Zhoukou, Henan, China
Xihua County People's Hospital — Zhoukou, Henan, China
Taihe Hospital, Hubei University of Medicine — Shiyan, Hubei, China
Tianmen First People's Hospital — Tianmen, Hubei, China
Changde First People's Hospital — Changde, Hunan, China
Liuyang Jili Hospital — Guankou, Hunan, China
The First Affiliated Hospital of Shaoyang University — Shaoyang, Hunan, China
Yiyang Central Hospital — Yiyang, Hunan, China
Xuzhou Cancer Hospital — Xuzhou, Jiangsu, China
Daliuta Experimental Area Hospital of Shenmu City — Shenmu, Shaanxi, China
Yan'an University Xianyang Hospital — Xianyang, Shaanxi, China
Feicheng Hospital of Shandong Yiyang Health Group — Feicheng, Shandong, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Jinan, Shandong, China
Linyi People's Hospital — Linyi, Shandong, China
Rizhao Hospital of Traditional Chinese Medicine — Rizhao, Shandong, China
PLA Joint Logistic Support Force 970th Hospital — Yantai, Shandong, China
Laizhou People's Hospital — Yantai, Shandong, China
Yiyuan County People's Hospital — Zibo, Shandong, China
Yuncheng Central Hospital — Yuncheng, Shanxi, China
Meishan Second People's Hospital — Meishan, Sichuan, China
Donggang Central Hospital — Nanchong, Sichuan, China
People's Hospital of Bortala Mongol Autonomous Prefecture — Bole, Xinjiang, China
People's Hospital of Bayingolin Mongolian Autonomous Prefecture — Korla, Xinjiang, China
Huize County People's Hospital — Qujing, Yunnan, China

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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