Clinical trial NCT06629116: Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Ischemia
Lead sponsor: Zhangzhou Municipal Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Human serum albumin is an important biological molecule that plays a critical role in maintaining intracellular osmotic pressure, combating oxidative stress, and suppressing inflammatory responses. Studies have indicated that serum albumin levels gradually decrease in acute-phase stroke patients, accompanied by increased blood-brain barrier disruption. Low albumin levels may exacerbate the progression of cerebral infarction. Furthermore, another study found a correlation between serum albumin levels and the prognosis of AIS. Research has confirmed that human serum albumin may have potential benefits in neuroprotection through mechanisms such as improving microcirculation, reducing oxidative stress, and inhibiting inflammatory responses.

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.

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.

Primary outcomes:
measure: Functional independence Rate
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
measure: Rate of independent ambulation
timeFrame: From enrollment to the end of treatment at 3 months
Other outcomes:
measure: sICH occurrence
timeFrame: within 72 hours after enrollment
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital
state: Fujian
Study officials:
affiliation: zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
name: Tingyu Yi, Postgraduate
role: PRINCIPAL_INVESTIGATOR
References: