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Clinical Trials in China / NCT07263308
Recruiting Phase 3

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

NCT07263308 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Phase 3
Started
2025-12-18
Last updated
2026-09-09

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

Albumin →Endovascular treatment

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)

Trial sites (56)

FacilityCityRegionStatus
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.

More Capital Medical University trials in China

Other trials for the same condition

Official registry record

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.

View NCT07263308 on ClinicalTrials.gov ↗ ← All trials in China