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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Ischemia
• Intervention / Treatment: Drug: 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).

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tingyu Yi, Postgraduate; Phone Number: +86-05962082582; Email: siyuyufen@163.com

Study Locations

• China
  • Fujian
    • Zhangzhou, Fujian, China, 363000
      • Recruiting
      • Zhangzhou Municipal Hospital
      • Contact: Tingyu Yi, MD; Phone Number: 15859635985; Email: siyuyufen@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: 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 Names: Albumin
No Intervention: Control group; Follow the current guidelines for standard conventional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional independence Rate	mRS score of 0-2	From enrollment to the end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of independent ambulation	modified Rankin Scale score of 0-3 scores	From enrollment to the end of treatment at 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
sICH occurrence	New occurs Intracranial hemorrhage with NIHSS increase >=4 points	within 72 hours after enrollment

Collaborators and Investigators

• Sponsor: Tingyu-Yi
• Investigators: Principal Investigator: Tingyu Yi, Postgraduate, Zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Stroke; Brain Infarction; Ischemic Stroke; Brain Ischemia; Cerebral Infarction
• Other Study ID Numbers: Human Serum Albumin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not sure

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No