The objective of this study is to evaluate the effectiveness and safety of endovascular therapy combined with 25% human albumin in the treatment of acute large vessel occlusive stroke.
Stroke is the second leading cause of death worldwide, 85% of which are acute ischemic strokes (AIS). Neuronal death is the primary pathological manifestation of acute ischemic stroke (AIS). Preclinical studies have revealed that neuroprotective agents can reduce neuronal damage and improve neurological outcomes in experimental animals. However, over the past 40 years, clinical translation of neuroprotective drugs has consistently failed. In 2015, with the publication of five randomized controlled trials (RCTs) on thrombectomy for anterior circulation, there was sufficient evidence-based support for thrombectomy in large vessel occlusion of the anterior circulation, ushering us into a new era of AIS treatment - the era of efficient reperfusion therapy. In this context, neuroprotective therapy should be re-examined as an adjunctive approach to reperfusion therapy. Albumin, the predominant plasma protein synthesized primarily in the liver, possesses various biochemical properties that are expected to confer a neuroprotective effect following acute ischemic stroke. This study is a multi-center, randomized, double-blind, placebo-controlled clinical study, focusing on patients with acute large vessel occlusive stroke. It aims to investigate the effectiveness and safety of albumin as an adjunctive treatment to endovascular therapy compared with placebo in reducing infarct volume, improving long-term functional outcomes, and daily living activities of patients with acute ischemic stroke in the era of reperfusion therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
134
Administer 0.5g/kg of 25% human albumin intravenously as soon as possible within 60 minutes after randomization. And administer 0.5g/kg of 25% ALB intravenously every day on the second, third, and fourth days after randomization.
Equivalent volume of isotonic saline control
Maanshan People's Hospital
Ma’anshan, Anhui, China
Suzhou Municipal Hospital of Anhui Province
Suzhou, Anhui, China
Luoyang Central Hospital Affiliated to Zhengzhou University
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
Changes in infarction volume from Day 5 to baseline.
Time frame: From 5 days after surgery to baseline
Early neurological improvement within 24 hours
Decrease in National Institute of Health stroke scale (NIHSS) score of ≥8 or NIHSS score of 0-2 within 24 hours. NIHSS scores range from 0 to 42, with higher scores indicating greater neurologic deficit
Time frame: within 24 hours
NIHSS score at 24 hours
National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating greater neurologic deficit
Time frame: at 24 hours
Proportion of successful reperfusion (mTICI 2b/3)
mTICI denotes modified Treatment in Cerebral Ischemia classification, with scores ranging from 0 (no flow) to 3 (normal flow)
Time frame: immediate postoperative
NIHSS score at 5 days
National Institutes of Health Stroke Scale (NIHSS)
Time frame: at 5 days
Proportion of patients with functional independence (mRS 0-1) at 90 days
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability
Time frame: at 90 days
Proportion of patients with functional independence (mRS 0-2) at 90 days
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability
Time frame: at 90 days
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First People's Hospital of Zhengzhou City
Zhengzhou, Henan, China
Xihua County People's Hospital
Zhoukou, Henan, China
Northern Jiangsu People's Hospita!
Yangzhou, Jiangsu, China
Liaocheng Third People's Hospital
Liaocheng, Shandong, China
Proportion of patients with Barthel Index of 95-100 at 90 days
Time frame: at 90 days
European quality of Life-5 Dimensions (EQ-5D) at 90 days
EQ-5D is a standardized instrument for the measurement of health status. Scores range from -0.33 to 1.00, with higher scores indicating a better quality of life
Time frame: at 90 days
Incidence of Symptomatic intracerebral hemorrhage (ICH) Within 24 Hours
Time frame: within 24 hours
Incidence of Intracerebral hemorrhage within 24 Hours
Time frame: within 24 hours
Neurological deterioration within 24 hours
NIHSS score increased by ≥4 points within 24 hours.
Time frame: within 24 hours
Incidence of New-onset atrial fibrillation within 5 days
Time frame: within 5 days
Incidence of Pulmonary edema or congestive heart failure within 5 days
Time frame: within 5 days
Incidence of Intracerebral hemorrhage within 5 days
Time frame: within 5 days
Incidence of Symptomatic intracerebral hemorrhage (ICH) Within 5 days
Time frame: within 5 days
Incidence of Decompressive craniectomy within 7 days
Time frame: within 7 days
Death within 90 days
Time frame: within 90 days
Number of participants who experience adverse events (AEs)
Time frame: within 90 days
Number of participants who experience serious adverse events (SAEs)
Time frame: within 90 days