Using human serum albumin to improve outcomes after stroke surgery

Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy: A Prospective, Multicenter, Open-label, Endpoint-blinded, Randomized Controlled Trial

This study tests if giving patients human serum albumin right after stroke surgery can help reduce swelling in the brain and improve recovery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhangzhou Municipal Hospital (other)
• Locations: 1 site (Zhangzhou, Fujian)
• Trial ID: NCT06629116 on ClinicalTrials.gov

What this trial studies

This project investigates the effects of human serum albumin on reducing postoperative cerebral edema and improving clinical outcomes in patients who have undergone mechanical thrombectomy for acute large-core ischemic stroke. The study focuses on patients with anterior circulation strokes and aims to understand how albumin can enhance neuroprotection by improving microcirculation and reducing inflammation. Participants will receive an intravenous infusion of human albumin shortly after their surgical procedure to assess its therapeutic efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with acute ischemic stroke and specific clinical criteria indicating significant neurological impairment.

Not a fit: Patients with severe pre-existing disabilities or those who do not meet the inclusion criteria for stroke severity may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to better recovery and reduced complications for stroke patients after thrombectomy.

How similar studies have performed: Previous studies have shown promising results with albumin therapy in animal models, but clinical efficacy in humans remains to be fully established.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years old.
2. Acute ischemic stroke patients with NIHSS score ≥ 6.
3. Pre-stroke mRS (modified Rankin Scale) score ≤ 1.
4. Onset of symptoms to presentation within 24 hours, including wake-up strokes or strokes without witnessed onset; the time of symptom onset is defined as the "last seen normal" time.
5. Confirmed by CTA/MRA/DSA to have anterior circulation large vessel occlusive ischemic stroke (occlusion of the internal carotid artery or M1 or M2 segments of the middle cerebral artery), responsible for acute ischemic stroke signs and symptoms.
6. ASPECTS (Alberta Stroke Program Early CT Score) on NCCT (non-contrast CT) 3-6 or cerebral perfusion imaging: core infarct volume (rCBF ≤ 30%) 50-100 ml.
7. Achieving vessel reperfusion of mTICI (modified Thrombolysis in Cerebral Infarction) grade 2b or 3 through mechanical thrombectomy.
8. Written informed consent signed by the patient or their legally authorized representative.

Exclusion Criteria:

1. Intracranial hemorrhage confirmed by head CT or MRI.
2. Pre-stroke mRS score \> 2.
3. Severe allergy or absolute contraindication to iodine-based contrast agents.
4. Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and inability to control with antihypertensive medication.
5. Blood glucose \< 50 mg/dl (2.8 mmol/L) or \> 400 mg/dl (22.2 mmol/L) and difficult to correct.
6. Genetic or acquired bleeding diathesis, deficiency of coagulation factors, or oral anticoagulation with INR \> 1.7.
7. Severe renal dysfunction defined as serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate (GFR) \< 30 ml/min, or need for hemodialysis or peritoneal dialysis.
8. Expected life expectancy \< 6 months.
9. Anticipated inability of the patient to complete the 90-day follow-up.
10. Suspected aortic dissection.
11. Brain tumors, intracranial aneurysms, or arteriovenous malformations with mass effect on imaging.
12. Neurological or psychiatric disorders affecting the assessment of the disease before the patient's stroke.
13. Pregnancy or reproductive-age women with positive urinary or serum β-human chorionic gonadotropin (HCG) test.
14. Currently participating in other clinical trials that may interfere with the results of this trial.
15. History of allergy to albumin.
16. Need for intermittent or long-term concomitant acute or chronic pulmonary diseases.
17. Congestive heart failure for any reason in the past 6 months or any condition requiring medication, hospitalization, etc., related to heart failure.
18. Symptomatic or diagnosed acute myocardial infarction, or occurrence of acute myocardial infarction within the past 6 months.
19. Other situations that the investigator believes are not suitable for participation or may pose significant risks to the patient.

Where this trial is running

Zhangzhou, Fujian

• Zhangzhou Municipal Hospital — Zhangzhou, Fujian, China (RECRUITING)

Study contacts

• Principal investigator: Tingyu Yi, Postgraduate — zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
• Study coordinator: Tingyu Yi, Postgraduate

Conditions: Cerebral Ischemia