Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy

Launched by TINGYU-YI · Oct 4, 2024

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ClinConnect Summary

This clinical trial is investigating whether a treatment called human serum albumin can help patients recover better after experiencing a large stroke in the front part of the brain. Specifically, the study aims to see if this treatment can reduce swelling in the brain and improve overall health outcomes following a procedure known as mechanical thrombectomy, which is used to remove blockages in the blood vessels of the brain.

To participate in this study, individuals must be between 18 and 80 years old and have had a specific type of stroke that meets certain medical criteria. This includes having a certain level of stroke severity and needing to have undergone the thrombectomy procedure. Participants will receive the treatment and will be monitored for 90 days to see how well they respond. If you or a loved one are considering joining this trial, it's important to discuss it with a healthcare provider to ensure it’s a good fit based on individual health needs.

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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.