Albumin added to clot-removal treatment for people with a large artery blockage stroke

Trial details

Who runs it

Capital Medical University

Trial code

NCT07263308

Record updated

29 October 2026

Original 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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Patients who have participated in other interventional clinical studies within 30 days before randomization or are currently participating in other interventional clinical studies; 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; Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications; 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; 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; Refractory hypertension that is difficult to control by medication (defined as systolic blood pressure > 220 mmHg, or diastolic blood pressure > 110 mmHg); 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.); The investigator believes that the subject has other conditions making it unsuitable for participating in this study; Elevated serum troponin concentration upon admission (>0.1 μg/L) ; 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; 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; Anticipated difficulty in completing endovascular treatment due to vascular tortuosity; Pregnancy, breastfeeding.

ClinicalTrials.gov NCT07263308