Albumin plus endovascular therapy for anterior large-vessel ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, open-label, randomized phase 3 trial that assigns eligible patients 1:1 to either albumin combined with endovascular therapy or endovascular therapy alone. All participants receive standard acute stroke care and secondary prevention per guideline recommendations, and baseline CT or MR angiography, laboratory tests, NIHSS, ASPECTS, and mRS are recorded. The study focuses on safety and functional outcomes after reperfusion therapy for anterior circulation large‑vessel occlusions, with a 90-day telephone follow-up collecting quality‑of‑life and outcome scales. The trial aims to determine whether adding albumin improves recovery without unacceptable adverse effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Susong County Hospital of Traditional Chinese Medicine
  Anqing, Anhui, China Recruiting
• Bozhou People's Hospital
  Bozhou, Anhui, China Recruiting
• Taihe County Hospital of Traditional Chinese Medicine
  Fuyang, Anhui, China Recruiting
• Ma'anshan People's Hospital
  Ma’anshan, Anhui, China Recruiting
• Si County People's Hospital
  Suzhou, Anhui, China Recruiting
• Wuwei People's Hospital
  Wuhu, Anhui, China Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Chuanjie Wu, MD
• Email: wuchuanjie@ccmu.edu.cn
• Phone: 010-83199439

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.