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

NCT06629116 | Recruiting DMC

• 1 other identifier: Human Serum Albumin
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Ischemia

Outcome Measures

Primary Outcomes (1)

• Functional independence Rate

  mRS score of 0-2

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (1)

• Rate of independent ambulation

  From enrollment to the end of treatment at 3 months

Other Outcomes (1)

• sICH occurrence

  within 72 hours after enrollment

Study Arms (2)

Albumin group

EXPERIMENTAL

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).

Control group

NO INTERVENTION

Follow the current guidelines for standard conventional treatment.

Interventions

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

Whether to administer albumin to AIS patients after intravascular thrombectomy and reperfusion.

Also known as: Albumin

Albumin group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old.
• Acute ischemic stroke patients with NIHSS score ≥ 6.
• Pre-stroke mRS (modified Rankin Scale) score ≤ 1.
• 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.
• 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.
• 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.
• Achieving vessel reperfusion of mTICI (modified Thrombolysis in Cerebral Infarction) grade 2b or 3 through mechanical thrombectomy.
• Written informed consent signed by the patient or their legally authorized representative.

You may not qualify if:

• Intracranial hemorrhage confirmed by head CT or MRI.
• Pre-stroke mRS score \> 2.
• Severe allergy or absolute contraindication to iodine-based contrast agents.
• Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and inability to control with antihypertensive medication.
• Blood glucose \< 50 mg/dl (2.8 mmol/L) or \> 400 mg/dl (22.2 mmol/L) and difficult to correct.
• Genetic or acquired bleeding diathesis, deficiency of coagulation factors, or oral anticoagulation with INR \> 1.7.
• 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.
• Expected life expectancy \< 6 months.
• Anticipated inability of the patient to complete the 90-day follow-up.
• Suspected aortic dissection.
• Brain tumors, intracranial aneurysms, or arteriovenous malformations with mass effect on imaging.
• Neurological or psychiatric disorders affecting the assessment of the disease before the patient's stroke.
• Pregnancy or reproductive-age women with positive urinary or serum β-human chorionic gonadotropin (HCG) test.
• Currently participating in other clinical trials that may interfere with the results of this trial.
• History of allergy to albumin.

Sponsors & Collaborators

• Tingyu-Yi: lead

Study Sites (1)

Zhangzhou Municipal Hospital

Zhangzhou, Fujian, 363000, China

RECRUITING

MeSH Terms

Conditions

Brain Ischemia

Interventions

Albumins

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Tingyu Yi, Postgraduate

  zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingyu Yi, Postgraduate

CONTACT

+86-05962082582; siyuyufen@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 8, 2024
• Study Start: January 30, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)