Adjuvant Normobaric Hyperoxia in Acute Ischemic Stroke Patients Transferred for Thrombectomy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 114
- 主要终点
- Level of disability measured by modified Rankin scale (mRS) score
研究概览
简要总结
The primary objective of this study is to estimate the efficacy and safety of NBO on 3-month functional outcome after acute ischemic stroke
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years old;
- •Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
- •No prior stroke in the last 3 months;
- •Time from stroke onset (last seen well) to randomization is within 9 hours;
- •(1) Baseline NIHSS score at 6 or more and Intracranial ICA or MCA-M1 or MCA-M2 dominant occlusion, with or without tandem cervical carotid stenosis or tandem cervical occlusion, confirmed by preoperative CTA (or MRA, DSA) and consistent with signs and symptoms; or (2) Baseline NIHSS score at 6 or more with a hyperdense MCA sign on non-contrast CT; or (3) Baseline NIHSS score at 12 or more;
- •NIHSS score 0 or 1 in the section of level of consciousness;
- •No significant pre-stroke disability (pre-stroke mRS 0--1);
- •ASPECTS at least 6 on non-contrast CT;
- •Patient is planned for transfer to a EVT-capable hospital for EVT;
- •Signed informed consent from the patient or the legally authorized representative (LAR).
排除标准
- •Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III or IV, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
- •Respiratory rate <= 10 or >= 30 breaths per minute;
- •Oxygen-dependence at baseline to maintain SaO2 > 95% or intubation at baseline;
- •Seizure at stroke onset;
- •Exhibiting symptoms of vomiting, or severe headache, or unconscious;
- •Rapidly improving neurological deficits or transient ischemic attack prior to consent;
- •Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal;
- •Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation;
- •Woman of childbearing potential known to be pregnant or with a positive pregnancy test;
- •Life expectancy < 90 days due to comorbidity;
- •Unlikely to complete the 90-day follow-up;
- •Participating in another clinical treatment trial, or completed participation within prior 30 days;
- •Receiving other cerebral protective agent (e.g., edaravone dexborneol, n-butylphthalide);
- •Evidence of acute intracranial hemorrhage on CT/MRI;
- •Significant mass effect with midline shift, defined as any deviation of midline structures such as the septum pellucidum, is observed on CT/MRI scans.
结局指标
主要结局
Level of disability measured by modified Rankin scale (mRS) score
时间窗: 90 days, 1 year after randomization
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
次要结局
- Functional independence defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-2 at follow up(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(90 days, 1 year after randomization)
- National Institutes of Health Stroke Scale (NIHSS)(24 hours after randomization)
- Early neurological improvement(24 hours after randomization)
- Alberta Stroke Program Early CT (ASPECT) score upon the Endovascular Thrombectomy (EVT) sites' admission(Day 0, Endovascular Thrombectomy (EVT) site admission)
- Barthel Index(90 days, 1 year after randomization)
- Change of Infarct volume at 24 hours from baseline(24 (+/- 12) hours after randomization)
- EuroQol five dimensions questionnaire（EQ-5D）(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)(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)(Day 5 (or discharge if earlier) after randomization)
- Spontaneous or IV thrombolysis induced recanalization from baseline to Endovascular Thrombectomy (EVT) site arrival(Day 0, Endovascular Thrombectomy (EVT) site admission)
- Spontaneous or IV thrombolysis induced recanalization from baseline to Endovascular Thrombectomy (EVT) site arrival(Day 0, Endovascular Thrombectomy (EVT) site admission)
- National Institutes of Health Stroke Scale (NIHSS)(24 hours after randomization)
- Early neurological improvement(24 hours after randomization)
- Alberta Stroke Program Early CT (ASPECT) score upon the Endovascular Thrombectomy (EVT) sites' admission(Day 0, Endovascular Thrombectomy (EVT) site admission)
- Change of Infarct volume at 24 hours from baseline(24 (+/- 12) hours after randomization)
- EuroQol five dimensions questionnaire（EQ-5D）(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)(Day 5 (or discharge if earlier) after randomization)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University