Head positioning after endovascular therapy for acute stroke due to large vessel occlusion (HeadSOAR): multicentre randomised controlled trial

OBJECTIVE: To determine whether an elevated head position (30-40°) improves functional outcomes compared with a flat head position (0-10°) in patients with acute ischaemic stroke caused by anterior circulation large vessel occlusion who have achieved successful reperfusion after endovascular thrombectomy. DESIGN: Multicentre, prospective, randomised, open label, blinded endpoint clinical trial. SETTING: 67 comprehensive stroke centres in China, between 16 November 2023 and 23 January 2025. PARTICIPANTS: 1368 adults (aged ≥18 years) with acute ischaemic stroke caused by anterior circulation large vessel occlusion who achieved successful endovascular reperfusion, defined as an expanded thrombolysis in cerebral infarction score ≥2b after endovascular thrombectomy. INTERVENTIONS: The primary outcome was functional status at 90 days after randomisation, assessed by shift analysis of scores on the modified Rankin scale (range 0-6). The primary safety outcome was all cause mortality at 90 days after randomisation. Efficacy analyses used the randomised, full analysis set, and safety analyses used the safety population (identical to the randomised population). Adjusted models included age, baseline National Institutes of Health Stroke Scale score (NIHSS), baseline Alberta Stroke Programme Early Computed Tomography Score, occlusion site, and time from last known well (ie, the last time when the patient was known to be at their usual neurological baseline before the current stroke event) to randomisation. RESULTS: In the population of 1368 randomised patients, the median age was 68 years, 565 participants (41.3%) were women, and 1358 (99.3%) completed the 90 day follow-up. The median baseline NIHSS score was 15, the median 90 day modified Rankin scale score was 3 (interquartile range (IQR) 1-5) in the head elevation group versus 3 (IQR 1-5) in the flat head position group (adjusted generalised odds ratio for a lower level of disability 1.12, 95% confidence interval (CI) 0.97 to 1.29, P=0.14). All cause mortality at 90 days occurred in 125 (18.3%) of 682 patients in the elevated head position group and 137 (20.3%) of 676 patients in the flat head position group (adjusted risk ratio 0.86, 95% CI 0.69 to 1.07, P=0.18). CONCLUSIONS: 72 hours of head elevation did not significantly improve 90 day functional outcomes versus flat head positioning in patients who had acute ischaemic stroke from large vessel occlusion with successful reperfusion after thrombectomy. The smaller than expected difference in results between the two groups leaves open the possibility of a modest but clinically meaningful benefit of head elevation in these patients. TRIAL: ClinicalTrials.gov NCT06115707.

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Journal
BMJ
Published
2026-08-20
DOI
https://doi.org/10.1136/bmj-2026-100363
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1
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Acute Ischemic Stroke Management
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article
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6.50
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article

Head positioning after endovascular therapy for acute stroke due to large vessel occlusion (HeadSOAR): multicentre randomised controlled trial

Tianqi Tu, Zhengzhou Yuan, Zhizhou Hu, Shuang Qiu et al.
1 citations
BMJ
Acute Ischemic Stroke Management
6.50
article

Head positioning after endovascular therapy for acute stroke due to large vessel occlusion (HeadSOAR): multicentre randomised controlled trial

Tianqi Tu, Zhengzhou Yuan, Zhizhou Hu, Shuang Qiu, Duolao Wang, Renliang Meng, Hongliang Zeng, Tao Hao, Weizheng Xie, Long Gu, Kecheng Guo, Guoyong Zeng, Chaoxiong Shen, Yong Qing Jiang, Jeffrey L. Saver, Raul G. Nogueira, Wei Rao, Maojun Jiang, Zhenhua Zhou, Yunbo Chen, Hao Zhu, Yunfei Li, Xiangping Cheng, Xiangrong Sun, Jinglun Li, D. Li, Thanh N Nguyen, Shuchun Huang, Qin Liu, Zhibing Ai, Yuan Yang, Fayun Hu, Gaoming Li, Bin Han, Zhou Yu, Boyu Chen, Wenjie Zi, Xiu Chen, Jian Wang, Chao Li, Wei Li, Xin Zhang, Changwei Guo, Wenlong Zhao, Junfeng Li, Chaoqun Li, Zhi Song, Jianhua Peng, Zhaokun Li, Tao Qiu, Mayank Goyal, Chong Zheng, Li Jiang, Xiurong Zhu, Ye Xiong, Li Yao, Bin Wang, Haoyue Wang
article en
1 citations

Abstract

OBJECTIVE: To determine whether an elevated head position (30-40°) improves functional outcomes compared with a flat head position (0-10°) in patients with acute ischaemic stroke caused by anterior circulation large vessel occlusion who have achieved successful reperfusion after endovascular thrombectomy. DESIGN: Multicentre, prospective, randomised, open label, blinded endpoint clinical trial. SETTING: 67 comprehensive stroke centres in China, between 16 November 2023 and 23 January 2025. PARTICIPANTS: 1368 adults (aged ≥18 years) with acute ischaemic stroke caused by anterior circulation large vessel occlusion who achieved successful endovascular reperfusion, defined as an expanded thrombolysis in cerebral infarction score ≥2b after endovascular thrombectomy. INTERVENTIONS: The primary outcome was functional status at 90 days after randomisation, assessed by shift analysis of scores on the modified Rankin scale (range 0-6). The primary safety outcome was all cause mortality at 90 days after randomisation. Efficacy analyses used the randomised, full analysis set, and safety analyses used the safety population (identical to the randomised population). Adjusted models included age, baseline National Institutes of Health Stroke Scale score (NIHSS), baseline Alberta Stroke Programme Early Computed Tomography Score, occlusion site, and time from last known well (ie, the last time when the patient was known to be at their usual neurological baseline before the current stroke event) to randomisation. RESULTS: In the population of 1368 randomised patients, the median age was 68 years, 565 participants (41.3%) were women, and 1358 (99.3%) completed the 90 day follow-up. The median baseline NIHSS score was 15, the median 90 day modified Rankin scale score was 3 (interquartile range (IQR) 1-5) in the head elevation group versus 3 (IQR 1-5) in the flat head position group (adjusted generalised odds ratio for a lower level of disability 1.12, 95% confidence interval (CI) 0.97 to 1.29, P=0.14). All cause mortality at 90 days occurred in 125 (18.3%) of 682 patients in the elevated head position group and 137 (20.3%) of 676 patients in the flat head position group (adjusted risk ratio 0.86, 95% CI 0.69 to 1.07, P=0.18). CONCLUSIONS: 72 hours of head elevation did not significantly improve 90 day functional outcomes versus flat head positioning in patients who had acute ischaemic stroke from large vessel occlusion with successful reperfusion after thrombectomy. The smaller than expected difference in results between the two groups leaves open the possibility of a modest but clinically meaningful benefit of head elevation in these patients. TRIAL: ClinicalTrials.gov NCT06115707.

BMJVol. 394
Hubei University of Medicine (CN), Boston Medical Center (US), Fujian Medical University (CN), Army Medical University (CN), University of California, Los Angeles (US), University of Pittsburgh (US), Shanxi Medical University (CN), Jilin University (CN), Liverpool School of Tropical Medicine (GB), Sichuan University (CN), Kunming Medical University (CN), Wenzhou Medical University (CN), First Affiliated Hospital of Wenzhou Medical University (CN), Foothills Medical Centre (CA), Affiliated Hospital of Southwest Medical University (CN), West China Hospital of Sichuan University (CN), Ganzhou People's Hospital (CN), Mianyang Central Hospital (CN), The Fifth People's Hospital of Anyang (CN), Ningxia Hui Autonomous Region Peoples Hospital (CN), Qujing Normal University (CN), Jiangxi Provincial People's Hospital (CN), Affiliated Hospital of North Sichuan Medical College (CN), The People's Hospital of Guangxi Zhuang Autonomous Region (CN), Taihe Hospital (CN), Xinqiao Hospital (CN), Zhujiang Hospital (CN), First Affiliated Hospital of Fujian Medical University (CN), Community Health Systems - Lutheran Hospital (US), Lanzhou University Second Hospital (CN), First Hospital of Jilin University (CN), Xintai People's Hospital (CN), Southwest Hospital (CN), Chongqing Emergency Medical Center (CN), The First People's Hospital of Tianmen (CN), Baise University (CN), China XD Group (China) (CN), Xian Yang Central Hospital (CN), Baoji City Central Hospital (CN), Zigong First People's Hospital (CN), Xiangshan County First People's Hospital (CN), Second People’s Hospital of Yibin (CN), Neurological Surgery (US), Shanxi Provincial People’s Hospital (CN), First People's Hospital of Chongqing (CN), Lanzhou University (CN), Hainan Medical University (CN), Chongqing Medical University (CN)
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Openalex Percentile: Top 3%
Acute Ischemic Stroke Management
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