The primary objective of this study is to estimate the efficacy and safety of NBO on 3-month functional outcome after acute ischemic stroke
Stroke is a leading cause of death and disability globally, with acute ischemic stroke (AIS) patients often benefiting from intravenous thrombolysis and endovascular therapies such as mechanical thrombectomy, which have been shown to improve reperfusion rates. However, despite reperfusion, the proportion of patients with large vessel occlusion achieving a favorable functional outcome, defined as a modified Rankin Scale score of 0-2 at 90 days, remains under 50%. Normobaric hyperoxia (NBO) emerges as a compelling option for cerebral protection. Its neuroprotective mechanisms are thought to include hypoxic tissue rescue, blood-brain barrier preservation, brain edema reduction, neuroinflammation alleviation, mitochondrial function improvement, oxidative stress mitigation, and apoptosis inhibition. NBO's diffusion properties allow it to reach the penumbra before reperfusion, enhancing aerobic metabolism and potentially reducing infarct volume. Its advantages also include low cost, wide availability, and ease of use, making it accessible across various healthcare settings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,500
Level of disability measured by modified Rankin scale (mRS) score
The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome; the primary outcome here is 3-month ordinal mRS score with mRS 5 and 6 merged into one category; modified intention-to-treat analysis
Time frame: 90 days, 1 year after randomization
Functional independence defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-2 at follow up
The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome. The mRS score is dichotomized to define the functional independence as mRS score of 0-2.
Time frame: 90 days, 1 year after randomization
Excellent functional outcome, defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-1 at follow up
The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome. The mRS score is dichotomized to define the excellent functional outcome as mRS score of 0-1.
Time frame: 90 days, 1 year after randomization
National Institutes of Health Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42 points, with higher scores indicating worse neurological deficits.
Time frame: 24 hours after randomization
Early neurological improvement
Neurological improvement is defined as a decrease of at least 4-point reduction in NIHSS score at 24 hours of randomization to baseline assessment
Time frame: 24 hours after randomization
Alberta Stroke Program Early CT (ASPECT) score upon the Endovascular Thrombectomy (EVT) sites' admission
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGFujian Medical University First Affiliated Hospital
Fuzhou, Fujian, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGFujian Minhou County Hospital
Fuzhou, Fujian, China
RECRUITINGFuqing Hospital
Fuzhou, Fujian, China
RECRUITINGFuqing Second Hospital
Fuzhou, Fujian, China
RECRUITINGFuzhou Changle District People's Hospital
Fuzhou, Fujian, China
RECRUITINGFuzhou Traditional Chinese Medicine Hospital
Fuzhou, Fujian, China
RECRUITINGLianjiang County General Hospital
Fuzhou, Fujian, China
RECRUITINGLuoyuan County Hospital
Fuzhou, Fujian, China
RECRUITING...and 102 more locations
Alberta Stroke Program Early CT (ASPECT) score ranges from 0 to 10, with 10 being normal and 0 indicating complete MCA infarction
Time frame: Day 0, Endovascular Thrombectomy (EVT) site admission
Change of Infarct volume at 24 hours from baseline
Both the infarct volume at 24 hours and the change of it from baseline will be analyzed
Time frame: 24 (+/- 12) hours after randomization
EuroQol five dimensions questionnaire(EQ-5D)
The score ranges from 0 to 100, with higher scores indicating optimal health
Time frame: 90 days, 1 year after randomization
Excellent functional outcome at day 5 (or discharge if earlier) defined as modified ranking scale (mRS) score of 0-1 at day 5 (or discharge if earlier)
The original modified ranking scale (mRS) score ranges from 0 to 6, with higher scores indicating a worse outcome. We use the dichotomozed mRS score to define the excellent functional outcome as mRS score of 0-1 at day 5 (or discharge if earlier).
Time frame: Day 5 (or discharge if earlier) after randomization
Functional independence at day 5 (or discharge if earlier) defined as modified ranking scale (mRS) score of 0-2 at day 5 (or discharge if earlier)
The original modified ranking scale (mRS) score ranges from 0 to 6, with higher scores indicating a worse outcome. We use the dichotomozed mRS score to define the functional independence as mRS score of 0-2 at day 5 (or discharge if earlier).
Time frame: Day 5 (or discharge if earlier) after randomization
Spontaneous or IV thrombolysis induced recanalization from baseline to Endovascular Thrombectomy (EVT) site arrival
Among patients who have related imaging from both the non-EVT and EVT sites
Time frame: Day 0, Endovascular Thrombectomy (EVT) site admission
Barthel Index
The Barthel Index is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)
Time frame: 90 days, 1 year after randomization