Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Level of disability at 90 days measured by modified Rankin scale (mRS) score
研究概览
简要总结
The primary objective of this study is to determine the efficacy and safety of inhaled normobaric hyperoxia therapy (NBO) beginning in the pre-hospital setting in patients with suspected acute cerebral ischemia (ACI) due to large vessel occlusion presenting within 6 hours of symptom onset.
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 18 to 80 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;
- •The time from stroke onset/last seen well to randomization is within 6 hours;
- •Paramedic-obtained FAST-ED score >= 3 (The enrollment of patients with a FAST-ED score of 3 is prespecified to constitute no more than 10% of the total study population);
- •No significant pre-stroke disability (pre-stroke mRS 0-1);
- •Signed informed consent from the patient or the legally authorized representative (LAR).
排除标准
- •Endotracheal intubation in the field (prior to consent);
- •Respiratory rate <= 10 or >= 30 breaths per minute;
- •Oxygen-dependence at baseline to maintain SaO2 > 95%;
- •Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
- •Seizure at stroke onset;
- •Exhibiting symptoms of vomiting, severe headache, or unconscious;
- •Known pregnancy: women of childbearing age (18 to 44 years old according to the CDC's Division of Reproductive Health) will be asked about their pregnancy status.
- •Participating in another clinical trial, or completed participation within prior 30 days;
- •Receiving other neuroprotective agent (e.g., edaravone dexborneol, n-butylphthalide);
- •Life expectancy < 90 days due to comorbidities;
- •Unlikely to complete the 90-day follow-up visit.
研究组 & 干预措施
NBO
NBO will be conducted with inhalation of 100% oxygen. NBO will be used in conjunction with best medical practice.
干预措施: NBO (Other)
Control
Best medical treatment
干预措施: Control (Other)
结局指标
主要结局
Level of disability at 90 days measured by modified Rankin scale (mRS) score
时间窗: 90 days 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 at 90 days defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up(90 days after randomization)
- Excellent functional outcome at 90 days, defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up(90 days after randomization)
- National Institutes of Health Stroke Scale (NIHSS) obtained obtained upon Endovascular Thrombectomy (EVT) site arrival(Day 0)
- NCCT infarct volume at 24 hours in patients undergoing thrombolysis or EVT (standard of care)(24 hours after randomization)
- National Institutes of Health Stroke Scale (NIHSS) obtained at 24 hours(24 hours after randomization)
- Proportion of patients with elevated troponin level upon EVT hospital arrival(Day 0)
- ASPECTS on admission head CT(Day 0)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University