Head Position After Endovascular Therapy
HeadSOAR
Head Positioning After Endovascular Therapy for Acute Ischemic Stroke: A Randomized Controlled Trial
1 other identifier
interventional
1,368
1 country
67
Brief Summary
The aim of this trial is to investigate whether head elevation position after endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedStudy Start
First participant enrolled
November 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2025
CompletedNovember 28, 2025
October 1, 2025
1.5 years
October 30, 2023
November 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Modified Rankin scale score (mRS)
disability level. The presence of impairments determines the transitions from mRS score 0 to mRS score 1 (symptoms) and mRS score 5 to mRS score 6 (death).
90 days
Secondary Outcomes (12)
Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1)
90 days
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
Within 90 days90 days
Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)
90 days
Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS)
90 days
Mortality within 90 days
90 days
- +7 more secondary outcomes
Study Arms (2)
The lying flat group
ACTIVE COMPARATORPatients in lying flat intervention to be nursed lying flat (0°-10°) after endovascular therapy is made and to remain in this position for 72 hours.
The head elevation group
EXPERIMENTALPatients in the sitting up intervention should be nursed with their head elevated (30°-40°) by raising the head of the bed (or using extra pillows or wedges) after undergoing endovascular therapy, and to remain in this position for 72 hours.
Interventions
The lying flat (0°-10°) head position for 72 hours after endovascular therapy.
The head elevoatin (30°-40°) position for 72 hours after endovascular therapy.
Eligibility Criteria
You may qualify if:
- Clinical signs consistent with acute ischemic stroke;
- Age ≥ 18 years old;
- Proved anterior circulation large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem);
- NIHSS score ≥ 8 points before endovascular treatment;
- ASPECTS score ≤ 7 points before endovascular treatment;
- Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ；
- The time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time);
- Written informed consent is obtained from patients and/or their legal representatives.
You may not qualify if:
- Pre-stroke mRS score\>1 point;
- Patients with acute occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation);
- Currently in pregnant or lactating or serum beta HCG test is positive on admission;
- Contraindications to a flat head position;
- Any terminal illness with life expectancy less than 6 months;
- Participating in other clinical trials;
- Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- Unlikely to be available for 90-day follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhengzhou Yuanlead
Study Sites (67)
Chongqing Banan District People's Hospital
Chongqing, Chongqing Municipality, China
Chongqing Bishan District People's Hospital
Chongqing, Chongqing Municipality, China
Chongqing Ninth People's Hospital
Chongqing, Chongqing Municipality, China
Yongchuan Hospital Affiliated to Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Longyan First Hospital
Longyan, Fujian, 364099, China
Dingxi People's Hospital
Dingxi, Gansu, China
Jiuquan People's Hospital
Jiuquan, Gansu, China
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu, China
Lanzhou University First Hospital
Lanzhou, Gansu, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Tianshui First People's Hospital
Tianshui, Gansu, China
Zhujiang Hospital of Southern Medical University
Guanzhou, Guangdong, China
Guangdong Provincial People's Hospital Heyuan Hospital
Heyuan, Guangdong, China
Baise People's Hospital
Baise City, Guangxi, China
Nanning Third People's Hospital
Nanning, Guangxi, China
Qiannan Prefecture People's Hospital
Duyun, Guizhou, China
Xingyi People's Hospital
Xingyi, Guizhou, China
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan, China
Jiamusi Central Hospital
Jiamusi, Heilongjiang, China
Yichun First Hospital
Yichun, Heilongjiang, China
Anyang People's Hospital
Anyang, Henan, China
Xihua County People's Hospital
Zhoukou, Henan, China
Shiyan taihe hospital
Shiyan, Hubei, China
Ningxiang First People's Hospital
Changsha, Hunan, China
The First People's Hospital of Chenzhou City
Chenzhou, Hunan, China
Ganzhou Municipal Hospital
Ganzhou, Jiangxi, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
Xingguo County People's Hospital
Ganzhou, Jiangxi, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Dalian 967 Hospital
Dalian, Liaoning, China
Ningxia Hui Autonomous Region People's Hospital
Yinchuan, Ningxia, China
The Fifth People's Hospital of Qinghai Province
Xining, Qinghai, China
Baoji High tech Hospital
Baoji, Shaanxi, China
Northwest University Affiliated Hospital
Xi'an, Shaanxi, China
Xidian Group Hospital
Xi'an, Shaanxi, China
Xianyang First People's Hospital
Xianyang, Shaanxi, China
Yulin First Hospital
Yulin, Shaanxi, China
Rizhao Traditional Chinese Medicine Hospital
Rizhao, Shandong, China
Shanxi Provincial Hospital
Taiyuan, Shanxi, China
Chengdu Sixth People's Hospital
Chengdu, Sichuan, China
Chongzhou People's Hospital
Chengdu, Sichuan, China
Deyang People's Hospital
Deyang, Sichuan, China
Guangyuan First People's Hospital
Guangyuan, Sichuan, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
Gulin County People's Hospital
Luzhou, Sichuan, China
Beichuan County People's Hospital
Mianyang, Sichuan, China
Mianyang 404 Hospital
Mianyang, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Neijiang Second People's Hospital
Neijiang, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Suining First People's Hospital
Suining, Sichuan, China
Liangshan First People's Hospital
Xichang, Sichuan, China
Xichang People's Hospital
Xichang, Sichuan, China
Ya'an People's Hospital
Ya'an, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Fushun County People's Hospital
Zigong, Sichuan, China
Zigong First People's Hospital
Zigong, Sichuan, China
Zigong Fourth People's Hospital
Zigong, Sichuan, China
Zigong Third People's Hospital
Zigong, Sichuan, China
The Seventh Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Qujing First People's Hospital
Qujing, Yunnan, China
Wenzhou Medical University First Affiliated Hospital
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhengzhou Yuan
Affiliated Hospital of Southwest Medical University
- STUDY CHAIR
Yong Jiang
Affiliated Hospital of Southwest Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 30, 2023
First Posted
November 3, 2023
Study Start
November 13, 2023
Primary Completion
April 26, 2025
Study Completion
April 26, 2025
Last Updated
November 28, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share