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

Recruiting now · Phase 3

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT07263308

Run by

Capital Medical University

People needed

1192

Starts

2025-12-18

Expected to finish

2027-12-01

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 80 years;
• Acute ischemic stroke with indications for endovascular treatment within 24 hours of onset;
• 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;
• National Institute of Health Stroke Scale (NIHSS) score >=6;
• Alberta Stroke Program Early CT Score (ASPECTS) >=3 points;
• Modified Rankin Scale (mRS) score ≤4 before onset of the disease;
• Written informed consent provided by the patients or their legal relatives.

You may not qualify if…

• 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;
• History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc;
• Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
• Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
• Pregnancy, breastfeeding;
• An episode or exacerbation of congestive heart failure from any cause in the past 6 months;
• History of heart valve disease complicated by congestive heart failure within the past 6 months;
• Cardiac surgery with thoracotomy (eg. coronary artery bypass grafting or valve replacement surgery) within the past 6 months;
• Acute myocardial infarction in the past 6 months;
• Signs or symptoms of acute myocardial infarction upon admission, including electrocardiographic findings;
• Elevated serum troponin concentration upon admission (>0.1 μg/L) ;
• Acute arrhythmia (including any tachycardia or bradycardia) with hemodynamic instability (systolic blood pressure <100 mm Hg) upon admission;
• Acute or chronic lung diseases requiring long-term or intermittent oxygen therapy;
• 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;
• Severe chronic anemia (hemoglobin < 75 g/L);
• Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 60 mL/min;
• Refractory hypertension that is difficult to control by medication (defined as systolic blood pressure > 220 mmHg, or diastolic blood pressure > 110 mmHg);
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greater than 1.5 times the upper limit of the normal value.
• History of albumin allergy or known allergy to albumin;
• Patients with severe mental disorders or dementia who are unable to cooperate in completing informed consent and follow-up content;
• The expected survival time is less than 90 days (such as comorbidity with malignant tumor or severe systemic diseases etc.);
• Patients who have participated in other interventional clinical studies within 30 days before randomization or are currently participating in other interventional clinical studies.
• The investigator believes that the subject has other conditions making it unsuitable for participating in this study.

Where it is running

• Laizhou People's Hospital — Yantai, Shandong, China (enrolling)
• Si County People's Hospital — Suzhou, Anhui, China (enrolling)
• Xuanwu Hospital，Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Shanghai General Hospital Jiujuan Hospital — Jiuquan, Gansu, China (enrolling)
• Gansu Provincial Hospital — Lanzhou, Gansu, China (enrolling)
• Jixi People's Hospital — Jixi, Heilongjiang, China (enrolling)
• Ningling County People's Hospital — Shangqiu, Henan, China (enrolling)
• The First Affiliated Hospital of Xinxiang Medical University — Weihui, Henan, China (enrolling)
• Taihe County Hospital of Traditional Chinese Medicine — Fuyang, Anhui, China (enrolling)
• Zhongmou County People's Hospital — Zhengzhou, Henan, China (enrolling)
• Rizhao Hospital of Traditional Chinese Medicine — Rizhao, Shandong, China (enrolling)
• The First Affiliated Hospital of Henan University of Chinese Medicine — Zhengzhou, Henan, China

Full record on ClinicalTrials.gov

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