Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy
NCT ID: NCT06629116
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-01-30
2027-05-30
Brief Summary
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Detailed Description
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In an experimental animal study of ischemic stroke, researchers discovered that in the middle cerebral artery occlusion (MCAO) model, rats treated with albumin showed significantly reduced neurological function scores and infarct volume compared to the saline group. The mechanism behind this effect may be related to albumin's ability to improve ischemic penumbral blood flow and enhance perfusion in occluded vessels' distal regions. Multiple preclinical studies have suggested that using albumin therapy after vascular recanalization can significantly reduce infarct volume, alleviate brain edema, and improve neurological function, highlighting the neuroprotective role of serum albumin. However, the clinical efficacy of serum albumin in ischemic stroke remains a subject of controversy.
The aim of this study is to investigate the role of human serum albumin in acute anterior circulation large core ischemic stroke after thrombectomy reperfusion, with the hope of providing new insights and methods for clinical treatment. This study will employ a prospective, multicenter, open-label, endpoint-blinded, randomized controlled research design to systematically evaluate the therapeutic effects of human serum albumin in acute anterior circulation large core ischemic stroke after thrombectomy reperfusion. Through clinical observation, imaging assessment, neurofunctional evaluation, and other methods, the investigators will delve into the intervention of human serum albumin in reperfusion injury and its mechanisms in neuroprotection. This research is expected to offer new perspectives and methods for the treatment of patients with acute anterior circulation large core ischemic stroke, provide scientific evidence for clinical practice, and contribute positively to improving patient outcomes and reducing the societal burden.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Albumin group
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.
Control group
Follow the current guidelines for standard conventional treatment.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Tingyu-Yi
OTHER
Responsible Party
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Tingyu-Yi
Doctor
Principal Investigators
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Tingyu Yi, Postgraduate
Role: PRINCIPAL_INVESTIGATOR
zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
Locations
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Zhangzhou Municipal Hospital
Zhangzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Human Serum Albumin
Identifier Type: -
Identifier Source: org_study_id
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