Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1500 participants
INTERVENTIONAL
2024-12-13
2027-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NBO
NBO will be conducted with inhalation of 100% oxygen. NBO will be used in conjunction with best medical practice.
NBO
NBO will be conducted with inhalation of 100% oxygen.
Control
Best medical treatment
Control
Best medical care
Interventions
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NBO
NBO will be conducted with inhalation of 100% oxygen.
Control
Best medical care
Eligibility Criteria
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Inclusion Criteria
2. 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);
3. No prior stroke in the last 3 months;
4. Time from stroke onset (last seen well) to randomization is within 9 hours;
5. (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;
6. NIHSS score 0 or 1 in the section of level of consciousness;
7. No significant pre-stroke disability (pre-stroke mRS 0--1);
8. ASPECTS at least 6 on non-contrast CT;
9. Patient is planned for transfer to a EVT-capable hospital for EVT;
10. Signed informed consent from the patient or the legally authorized representative (LAR).
Exclusion Criteria
2. Respiratory rate \<= 10 or \>= 30 breaths per minute;
3. Oxygen-dependence at baseline to maintain SaO2 \> 95% or intubation at baseline;
4. Seizure at stroke onset;
5. Exhibiting symptoms of vomiting, or severe headache, or unconscious;
6. Rapidly improving neurological deficits or transient ischemic attack prior to consent;
7. Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal;
8. Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation;
9. Woman of childbearing potential known to be pregnant or with a positive pregnancy test;
10. Life expectancy \< 90 days due to comorbidity;
11. Unlikely to complete the 90-day follow-up;
12. Participating in another clinical treatment trial, or completed participation within prior 30 days;
13. Receiving other cerebral protective agent (e.g., edaravone dexborneol, n-butylphthalide);
14. Evidence of acute intracranial hemorrhage on CT/MRI;
15. Significant mass effect with midline shift, defined as any deviation of midline structures such as the septum pellucidum, is observed on CT/MRI scans.
18 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Ji Xunming,MD,PhD
Principal Investigator
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fujian Medical University First Affiliated Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Minhou County Hospital
Fuzhou, Fujian, China
Fuqing Hospital
Fuzhou, Fujian, China
Fuqing Second Hospital
Fuzhou, Fujian, China
Fuzhou Changle District People's Hospital
Fuzhou, Fujian, China
Fuzhou Traditional Chinese Medicine Hospital
Fuzhou, Fujian, China
Lianjiang County General Hospital
Fuzhou, Fujian, China
Luoyuan County Hospital
Fuzhou, Fujian, China
Minqing County General Hospital
Fuzhou, Fujian, China
Yongtai County Hospital
Fuzhou, Fujian, China
Gutian County Hospital
Ningde, Fujian, China
Putian Hanjiang District Hospital
Putian, Fujian, China
Dongshan County Hospital
Zhangzhou, Fujian, China
Nanjing County Hospital
Zhangzhou, Fujian, China
Pinghe County Hospital
Zhangzhou, Fujian, China
Xiage Health Center
Zhangzhou, Fujian, China
Yunxiao County Hospital
Zhangzhou, Fujian, China
Yunxiao County Traditional Chinese Medicine Hospital
Zhangzhou, Fujian, China
Zhangpu County Hospital
Zhangzhou, Fujian, China
Zhangpu County Traditional Chinese Medicine Hospital
Zhangzhou, Fujian, China
Zhangzhou Changtai District Hospital
Zhangzhou, Fujian, China
Zhangzhou Fifth Hospital
Zhangzhou, Fujian, China
Zhangzhou Gulei Port Economic Development Zone First Hospital
Zhangzhou, Fujian, China
Zhangzhou Hospital Headquarters (High-Tech Campus)
Zhangzhou, Fujian, China
Zhangzhou Hospital
Zhangzhou, Fujian, China
Zhangzhou Second Hospital
Zhangzhou, Fujian, China
Zhao'an County Hospital
Zhangzhou, Fujian, China
Guangzhou Development District Hospital
Guangzhou, Guangdong, China
Guangzhou He Xian Memorial Hospital
Guangzhou, Guangdong, China
Jinan University First Affiliated Hospital
Guangzhou, Guangdong, China
Yifeng County People's Hospital
Guangzhou, Guangdong, China
Fuchuan Yao Autonomous County Ethnic Medicine Hospital
Hezhou, Guangxi, China
Hezhou Traditional Chinese Medicine Hospital
Hezhou, Guangxi, China
Zhaoping County People's Hospital
Hezhou, Guangxi, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Dongguang County People's Hospital
Cangzhou, Hebei, China
Xianxian Traditional Chinese Medicine Hospital
Cangzhou, Hebei, China
Daming County Traditional Chinese Medicine Hospital
Handan, Hebei, China
Handan Central Hospital (East Campus)
Handan, Hebei, China
Handan Fourth Hospital
Handan, Hebei, China
Linzhang County People's Hospital
Handan, Hebei, China
Quzhou County Hospital
Handan, Hebei, China
Linkou County People's Hospital
Mudanjiang, Heilongjiang, China
Mudanjiang Second People's Hospital
Mudanjiang, Heilongjiang, China
Luoyang Central Hospital
Luoyang, Henan, China
Song County People's Hospital
Luoyang, Henan, China
Xin'an County People's Hospital
Luoyang, Henan, China
Yichuan County People's Hospital
Luoyang, Henan, China
Yima People's Hospital
Yima, Henan, China
Yimei General Hospital
Yima, Henan, China
Danchuan County Traditional Chinese Medicine Hospital
Zhoukou, Henan, China
Luyi Zhenyuan Hospital
Zhoukou, Henan, China
Shenqiu County People's Hospital
Zhoukou, Henan, China
Zhoukou Central Hospital
Zhoukou, Henan, China
Danchuan Central Hospital
Zhoukou, Hennan, China
Hubei Minzu University Affiliated Minzu Hospital
Enshi, Hubei, China
Huangmei County People's Hospital
Huanggang, Hubei, China
Lichuan Traditional Chinese Medicine Hospital
Lichuan, Hubei, China
Dexing People's Hospital
Dexing, Jiangxi, China
Guangchang County People's Hospital
Fuzhou, Jiangxi, China
Jinxi County People's Hospital
Fuzhou, Jiangxi, China
Zixi County People's Hospital
Fuzhou, Jiangxi, China
Dean County People's Hospital
Jiujiang, Jiangxi, China
Dean County Traditional Chinese Medicine Hospital
Jiujiang, Jiangxi, China
Hukou County People's Hospital
Jiujiang, Jiangxi, China
Jiujiang First People's Hospital
Jiujiang, Jiangxi, China
Pengze County People's Hospital
Jiujiang, Jiangxi, China
Xiajiang County People's Hospital
Jiāan, Jiangxi, China
Xingan County People's Hospital
Jiāan, Jiangxi, China
Yongfeng County Traditional Chinese Medicine Hospital
Jiāan, Jiangxi, China
Lushan People's Hospital
Lushancun, Jiangxi, China
Anyi County People's Hospital
Nanchang, Jiangxi, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Xinjian District People's Hospital
Nanchang, Jiangxi, China
Poyang County People's Hospital
Shangrao, Jiangxi, China
Wannian County People's Hospital
Shangrao, Jiangxi, China
Fengxin County People's Hospital
Yichun, Jiangxi, China
Shanggao County People's Hospital
Yichun, Jiangxi, China
Yujiang District People's Hospital
Yingtan, Jiangxi, China
Zhangshu People's Hospital
Zhangshu, Jiangxi, China
Baoji High-Tech Hospital
Baoji, Shaanxi, China
Caijiapo Hospital
Baoji, Shaanxi, China
Longxian People's Hospital
Baoji, Shaanxi, China
Meixian Traditional Chinese Medicine Hospital
Baoji, Shaanxi, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Feicheng Hospital of Shandong Yiyang Health Group
Taiāan, Shandong, China
Jincheng First People's Hospital
Jinzhong, Shanxi, China
Xiyang County People's Hospital
Jinzhong, Shanxi, China
Wenshui County People's Hospital
LĆ¼liang, Shanxi, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Binchuan County People's Hospital
Dali, Yunnan, China
Binchuan County Traditional Chinese Medicine Hospital
Dali, Yunnan, China
Dali Prefecture People's Hospital
Dali, Yunnan, China
Heqing County People's Hospital
Dali, Yunnan, China
Jianchuan County People's Hospital
Dali, Yunnan, China
Midu County People's Hospital
Dali, Yunnan, China
Nanjian Yi Autonomous County People's Hospital
Dali, Yunnan, China
Yangbi County People's Hospital
Dali, Yunnan, China
Yongping County People's Hospital
Dali, Yunnan, China
Chenggong District People's Hospital
Kunming, Yunnan, China
Jinning District People's Hospital
Kunming, Yunnan, China
Kunming Medical University Yan'an Hospital
Kunming, Yunnan, China
Songming County People's Hospital
Kunming, Yunnan, China
Yiliang First People's Hospital
Kunming, Yunnan, China
Yunnan Provincial First People's Hospital
Kunming, Yunnan, China
The First People's Hospital of Qujing
Qujing, Yunnan, China
Fuyuan County People's Hospital
Qujing, Yunnan, China
Shizong County People's Hospital
Qujing, Yunnan, China
Xuanwei First People's Hospital
Xuanwei, Yunnan, China
Yuxi Zhongshan Hospital
Yuxi, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AN-O2
Identifier Type: -
Identifier Source: org_study_id
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