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RECRUITING

NCT06666764

PHASE3

Normobaric Oxygen in AIS Transferred for EVT

Sponsor: Capital Medical University

View on ClinicalTrials.gov

Summary

The primary objective of this study is to estimate the efficacy and safety of NBO on 3-month functional outcome after acute ischemic stroke

Official title: Adjuvant Normobaric Hyperoxia in Acute Ischemic Stroke Patients Transferred for Thrombectomy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2024-12-13

Completion Date

2027-10

Last Updated

2025-12-11

Healthy Volunteers

Conditions

Ischemic Stroke

Interventions

OTHER

NBO

NBO will be conducted with inhalation of 100% oxygen.

OTHER

Control

Best medical care

Inclusion Criteria: 1. Age at least 18 years old; 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: 1. 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; 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.

Locations (112)

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

Ji’an, Jiangxi, China

Xingan County People's Hospital

Ji’an, Jiangxi, China

Yongfeng County Traditional Chinese Medicine Hospital

Ji’an, 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

Tai’an, Shandong, China

Jincheng First People's Hospital

Jinzhong, Shanxi, China

Xiyang County People's Hospital

Jinzhong, Shanxi, China

Wenshui County People's Hospital

Lüliang, 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

Clinical Research Directory

Normobaric Oxygen in AIS Transferred for EVT

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)