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Clinical Trials in China / NCT06629116
Recruiting Not applicable

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

NCT06629116 · tracked via the Priya Life Science China tracker
Sponsor
Tingyu-Yi
Phase
Not applicable
Started
2024-01-30
Last updated
2024-10-08

Condition(s) studied

Cerebral Ischemia

Investigational drug(s) / intervention(s)

Patients with AIS receive intravascular therapy, and within 10 minutes after the surgery, they are administered 100ml of 20% human albumin intravenously (infused within 30 minutes).

Patients with AIS receive intravascular therapy, and within 10 minutes after the surgery, they are administered 100ml of 20% human albumin intravenously (infused within 30 minutes).: Whether to administer albumin to AIS patients after intravascular thrombectomy and reperfusion.

Study summary

This project intends to explore the therapeutic efficacy of human serum albumin in mitigating postoperative cerebral edema and enhancing clinical outcomes following mechanical thrombectomy in patients with acute anterior circulation large-core ischemic stroke.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhangzhou Municipal Hospital Zhangzhou Fujian Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06629116 on ClinicalTrials.gov ↗ ← All trials in China