Stroke, AcuteHeadSOARNCT06115707
Head Position After Endovascular Therapy
A study testing The lying flat (0°-10°) head position for 72 hours and The The head elevation (30°-40°) position for 72 hours in people with Stroke, Acute and Endovascular Therapy, run by Zhengzhou Yuan at 67 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Endovascular Therapy
- What is being tested?
- The lying flat (0°-10°) head position for 72 hours and The The head elevation (30°-40°) position for 72 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,368 participants
- Where
- 67 sitesChina
- Study dates
- 13 Nov 2023to 26 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
China67 sites
Anyang People's Hospital
Anyang, Henan
Baise People's Hospital
Baise City, Guangxi
Baoji High tech Hospital
Baoji, Shaanxi
The First Hospital of Jilin University
Changchun, Jilin
Ningxiang First People's Hospital
Changsha, Hunan
Chengdu Sixth People's Hospital
Chengdu, Sichuan
Chongzhou People's Hospital
Chengdu, Sichuan
The First People's Hospital of Chenzhou City
Chenzhou, Hunan
Chongqing Banan District People's Hospital
Chongqing, Chongqing Municipality
Chongqing Bishan District People's Hospital
Chongqing, Chongqing Municipality
Chongqing Ninth People's Hospital
Chongqing, Chongqing Municipality
Yongchuan Hospital Affiliated to Chongqing Medical University
Chongqing, Chongqing Municipality
Dalian 967 Hospital
Dalian, Liaoning
Deyang People's Hospital
Deyang, Sichuan
Dingxi People's Hospital
Dingxi, Gansu
Qiannan Prefecture People's Hospital
Duyun, Guizhou
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Ganzhou Municipal Hospital
Ganzhou, Jiangxi
Ganzhou People's Hospital
Ganzhou, Jiangxi
Xingguo County People's Hospital
Ganzhou, Jiangxi
Guangyuan First People's Hospital
Guangyuan, Sichuan
Zhujiang Hospital of Southern Medical University
Guanzhou, Guangdong
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan
Guangdong Provincial People's Hospital Heyuan Hospital
Heyuan, Guangdong
Jiamusi Central Hospital
Jiamusi, Heilongjiang
Jiuquan People's Hospital
Jiuquan, Gansu
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu
Lanzhou University First Hospital
Lanzhou, Gansu
Lanzhou University Second Hospital
Lanzhou, Gansu
Longyan First Hospital
Longyan, Fujian, 364099
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Gulin County People's Hospital
Luzhou, Sichuan
Beichuan County People's Hospital
Mianyang, Sichuan
Mianyang 404 Hospital
Mianyang, Sichuan
Mianyang Central Hospital
Mianyang, Sichuan
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan
Nanning Third People's Hospital
Nanning, Guangxi
Neijiang Second People's Hospital
Neijiang, Sichuan
Qujing First People's Hospital
Qujing, Yunnan
Rizhao Traditional Chinese Medicine Hospital
Rizhao, Shandong
Shiyan taihe hospital
Shiyan, Hubei
Suining Central Hospital
Suining, Sichuan
Suining First People's Hospital
Suining, Sichuan
Shanxi Provincial Hospital
Taiyuan, Shanxi
Tianshui First People's Hospital
Tianshui, Gansu
The Seventh Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Wenzhou Medical University First Affiliated Hospital
Wenzhou, Zhejiang
Northwest University Affiliated Hospital
Xi'an, Shaanxi
Xidian Group Hospital
Xi'an, Shaanxi
Xianyang First People's Hospital
Xianyang, Shaanxi
Liangshan First People's Hospital
Xichang, Sichuan
Xichang People's Hospital
Xichang, Sichuan
Xingyi People's Hospital
Xingyi, Guizhou
The Fifth People's Hospital of Qinghai Province
Xining, Qinghai
Ya'an People's Hospital
Ya'an, Sichuan
Yibin Second People's Hospital
Yibin, Sichuan
Yichun First Hospital
Yichun, Heilongjiang
Ningxia Hui Autonomous Region People's Hospital
Yinchuan, Ningxia
Yulin First Hospital
Yulin, Shaanxi
Xihua County People's Hospital
Zhoukou, Henan
Fushun County People's Hospital
Zigong, Sichuan
Zigong First People's Hospital
Zigong, Sichuan
Zigong Fourth People's Hospital
Zigong, Sichuan
Zigong Third People's Hospital
Zigong, Sichuan
About this study
Official title: Head Positioning After Endovascular Therapy for Acute Ischemic Stroke: A Randomized Controlled Trial
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.
Read the detailed description
The optimal head position for patients with acute ischemic stroke (AIS) remains uncertain. The HeadPoS study revealed that there is no significant difference in disability outcomes between patients who are placed in a lying-flat position for 24 hours and those who are placed in a sitting-up position with the head elevated to at least 30 degrees for 24 hours. However, this study included both patients with ischemic and hemorrhagic strokes, and most of the patients had mild strokes (median National Institutes of Health Stroke Scale score of 4). It is unclear how to arrange the patient's head position after endovascular treatment.
The hypothesis of this trial: Compared with the lying flat head positioni, the head elevation position after endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.
- Conditions
- Stroke, Acute, Endovascular Therapy
- Being tested
- The lying flat (0°-10°) head position for 72 hours, The The head elevation (30°-40°) position for 72 hours
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The lying flat (0°-10°) head position for 72 hoursOther
The lying flat (0°-10°) head position for 72 hours after endovascular therapy.
The The head elevation (30°-40°) position for 72 hoursOther
The head elevoatin (30°-40°) position for 72 hours after endovascular therapy.
| Study group | Role | What they receive |
|---|---|---|
| The lying flat group | Active comparator | Patients 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. Receives: Other: The lying flat (0°-10°) head position for 72 hours |
| The head elevation group | Experimental | Patients 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. Receives: Other: The The head elevation (30°-40°) position for 72 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
excellent outcome
Measured: 90 days
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
functional independence
Measured: Within 90 days90 days
Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)
ambulatory or bodily needs-capable or better
Measured: 90 days
Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS)
Health-related quality of life
Measured: 90 days
Mortality within 90 days
evaluate death rate of the two treatment groups
Measured: 90 days
severe adverse events
evaluate complications and any adverse events
Measured: within 90 days
Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria)
evaluate intracranial hemorrhage
Measured: within 72 hours after randomized
Any type of intracerebral hemorrhage (Heidelberg Criteria)
evaluate intracranial hemorrhage
Measured: within 72 hours after randomized
Brain edema
evaluate brain edema
Measured: within 72 hours after randomized
Malignant Brain Edema
evaluate brain edema
Measured: within 72 hours after randomized
Incidence of pulmonary infections
evaluate pulmonary infections
Measured: within 72 hours after randomized
Improvement in National Institute of Health stroke scale (NIHSS) score between baseline and 5~7d
neurological changes.
Measured: at 5~7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start13 Nov 2023
- Primary completion26 Apr 2025
- Study completion26 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhengzhou Yuan, The Affiliated Hospital Of Southwest Medical University
- Investigators
- Zhengzhou Yuan, Study chair, Affiliated Hospital of Southwest Medical UniversityYong Jiang, Study chair, Affiliated Hospital of Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115707
- Sponsor's protocol ID
- SWMU202305
- Acronym
- HeadSOAR
- Status last verified
- Oct 2025
- First submitted
- 30 Oct 2023
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuan Z, Peng J, Gu L, Hu F, Li G, Li J, Zheng C, Guo C, Wang B, Zeng H, Xie W, Guo K, Tu T, Zeng G, Hao T, Cheng X, Chen B, Wang H, Wang J, Han B, Huang S, Zhu H, Zhu X, Qiu T, Chen Y, Yu Z, Rao W, Li J, Yao L, Sun X, Li D, Li Y, Li W, Li Z, Xiong Y, Jiang M, Li C, Liu Q, Ai Z, Li C, Zhao W, Shen C, Hu Z, Song Z, Zhang X, Chen X, Yang Y, Meng R, Jiang L, Qiu S, Wang D, Zhou Z, Nguyen TN, Goyal M, Nogueira RG, Saver JL, Zi W, Jiang Y. Head positioning after endovascular therapy for acute stroke due to large vessel occlusion (HeadSOAR): multicentre randomised controlled trial. BMJ. 2026 Aug 20;394:e100363. doi: 10.1136/bmj-2026-100363.
PubMed 42624516
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Positioning After Endovascular Therapy for Acute Ischemic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06115707
- Acronym / sponsor ID
- HeadSOAR / SWMU202305
- Conditions
- Stroke, Acute, Endovascular Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,368 participants (actual)
- Lead sponsor
- Zhengzhou YuanUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 26 Apr 2025 (actual)
- Study completion
- 26 Apr 2025 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The optimal head position for patients with acute ischemic stroke (AIS) remains uncertain. The HeadPoS study revealed that there is no significant difference in disability outcomes between patients who are placed in a lying-flat position for 24 hours and those who are placed in a sitting-up position with the head elevated to at least 30 degrees for 24 hours. However, this study included both patients with ischemic and hemorrhagic strokes, and most of the patients had mild strokes (median National Institutes of Health Stroke Scale score of 4). It is unclear how to arrange the patient's head position after endovascular treatment.
The hypothesis of this trial: Compared with the lying flat head positioni, the head elevation position after endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The lying flat group | Active comparator | Other: The lying flat (0°-10°) head position for 72 hoursPatients 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 | Experimental | Other: The The head elevation (30°-40°) position for 72 hoursPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The lying flat (0°-10°) head position for 72 hoursThe lying flat (0°-10°) head position for 72 hours after endovascular therapy. | Other | The lying flat group |
| The The head elevation (30°-40°) position for 72 hoursThe head elevoatin (30°-40°) position for 72 hours after endovascular therapy. | Other | The head elevation group |
Primary outcome
Modified Rankin scale score (mRS)
Time frame: 90 days
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).
12 secondary outcomes
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)
Time frame: 90 days
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
Time frame: Within 90 days90 days
Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)
Time frame: 90 days
Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS)
Time frame: 90 days
Mortality within 90 days
Time frame: 90 days
severe adverse events
Time frame: within 90 days
Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria)
Time frame: within 72 hours after randomized
Any type of intracerebral hemorrhage (Heidelberg Criteria)
Time frame: within 72 hours after randomized
Brain edema
Time frame: within 72 hours after randomized
Malignant Brain Edema
Time frame: within 72 hours after randomized
Incidence of pulmonary infections
Time frame: within 72 hours after randomized
Improvement in National Institute of Health stroke scale (NIHSS) score between baseline and 5~7d
Time frame: at 5~7 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Derived from this study: PubMed 42624516Yuan Z, Peng J, Gu L, Hu F, Li G, Li J, Zheng C, Guo C, Wang B, Zeng H, Xie W, Guo K, Tu T, Zeng G, Hao T, Cheng X, Chen B, Wang H, Wang J, Han B, Huang S, Zhu H, Zhu X, Qiu T, Chen Y, Yu Z, Rao W, Li J, Yao L, Sun X, Li D, Li Y, Li W, Li Z, Xiong Y, Jiang M, Li C, Liu Q, Ai Z, Li C, Zhao W, Shen C, Hu Z, Song Z, Zhang X, Chen X, Yang Y, Meng R, Jiang L, Qiu S, Wang D, Zhou Z, Nguyen TN, Goyal M, Nogueira RG, Saver JL, Zi W, Jiang Y. Head positioning after endovascular therapy for acute stroke due to large vessel occlusion (HeadSOAR): multicentre randomised controlled trial. BMJ. 2026 Aug 20;394:e100363. doi: 10.1136/bmj-2026-100363.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhengzhou Yuan study chair
Affiliated Hospital of Southwest Medical University
Yong Jiang study chair
Affiliated Hospital of Southwest Medical University
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The lying flat (0°-10°) head position for 72 hours and The The head elevation (30°-40°) position for 72 hours in people with Stroke, Acute and Endovascular Therapy, run by Zhengzhou Yuan at 67 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin scale score (mRS) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06115707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.