Head Position After Endovascular Therapy

Stroke, Acute Clinical Trial

— HeadSOAR  

Official title:

Head Positioning After Endovascular Therapy for Acute Ischemic Stroke: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115707
• Other study ID #: SWMU202305
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: April 20, 2027

Study information

• Verified date: May 2024
• Source: The Affiliated Hospital Of Southwest Medical University
• Contact: Zhengzhou Yuan
• Phone: 868303165661
• Email: coneuro[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1332
• Est. completion date: April 20, 2027
• Est. primary completion date: November 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinical signs consistent with acute ischemic stroke;

2. Age = 18 years old;

3. Proved anterior circulation intracranial large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem);

4. NIHSS score = 8 points before endovascular treatment;

5. ASPECTS score = 7 points before endovascular treatment;

6. Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ;

7. The time from onset to randomization = 24 hours (the onset time is defined as the last normal time);

8. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

1. Pre-stroke mRS score>1 point;

2. Patients with occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation);

3. Currently in pregnant or lactating or serum beta HCG test is positive on admission;

4. Immediate after endovascular treatment, CT indicates brain hemorrhage with significant mass effect;

5. Contraindications to a flat head position;

6. Any terminal illness with life expectancy less than 6 months;

7. Participating in other clinical trials;

8. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;

9. Unlikely to be available for 90-day follow-up.

Related Conditions & MeSH terms

• Endovascular Therapy
• Stroke
• Stroke, Acute

Intervention

Other:
• The lying flat (0°-10°) head position for 72 hours
The lying flat (0°-10°) head position for 72 hours after endovascular therapy.
• The The head elevation (30°-40°) position for 72 hours
The head elevoatin (30°-40°) position for 72 hours after endovascular therapy.

Locations

Country	Name	City	State
China	Anyang People's Hospital	Anyang	Henan
China	Baise People's Hospital	Baise	Guangxi
China	Baoji High tech Hospital	Baoji	Shaanxi
China	Ningxiang First People's Hospital	Changsha	Hunan
China	Chengdu Sixth People's Hospital	Chengdu	Sichuan
China	Chongzhou People's Hospital	Chengdu	Sichuan
China	Chongqing Banan District People's Hospital	Chongqing	Chongqing
China	Chongqing Bishan District People's Hospital	Chongqing	Chongqing
China	Chongqing Ninth People's Hospital	Chongqing	Chongqing
China	Yongchuan Hospital Affiliated to Chongqing Medical University	Chongqing	Chongqing
China	Dalian 967 Hospital	Dalian	Liaoning
China	Deyang People's Hospital	Deyang	Sichuan
China	Dingxi People's Hospital	Dingxi	Gansu
China	Qiannan Prefecture People's Hospital	Dujun	Guizhou
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Ganzhou Municipal Hospital	GanZhou	Jiangxi
China	Ganzhou People's Hospital	Ganzhou	Jiangxi
China	Xingguo County People's Hospital	Ganzhou	Jiangxi
China	Guangyuan First People's Hospital	Guangyuan	Sichuan
China	Zhujiang Hospital of Southern Medical University	Guanzhou	Guangdong
China	The First Affiliated Hospital of Hainan Medical College	Haikou	Hainan
China	Jiamusi Central Hospital	Jiamusi	Heilongjiang
China	Jiuquan People's Hospital	Jiuquan	Gansu
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
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	Longyan First Hospital	Longyan	Fujian
China	Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
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	Nanning Third People's Hospital	Nanning	Guangxi
China	Neijiang Second People's Hospital	Neijiang	Sichuan
China	Qujing First People's Hospital	Qujing	Yunnan
China	Shiyan taihe hospital	Shiyan	Hubei
China	Suining Central Hospital	Suining	Sichuan
China	Suining First People's Hospital	Suining	Sichuan
China	Shanxi Provincial Hospital	Taiyuan	Shanxi
China	Tianshui First People's Hospital	Tianshui	Gansu
China	The Seventh Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Wenzhou Medical University First Affiliated Hospital	Wenzhou	Zhejiang
China	Northwest University Affiliated Hospital	Xi'an	Shaanxi
China	Xidian Group Hospital	Xi'an	Shanxi
China	Xianyang First People's Hospital	Xianyang	Shaanxi
China	Liangshan First People's Hospital	Xichang	Sichuan
China	Xichang People's Hospital	Xichang	Sichuan
China	Xingyi People's Hospital	Xingyi	Guizhou
China	The Fifth People's Hospital of Qinghai Province	Xining	Qinghai
China	Ya'an People's Hospital	Ya'an	Sichuan
China	Yibin Second People's Hospital	Yibin	Sichuan
China	Yichun First Hospital	Yichun	Heilongjiang
China	Ningxia Hui Autonomous Region People's Hospital	Yinchuan	Ningxia
China	Yulin First Hospital	Yulin	Shaanxi
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

Sponsors (1)

Lead Sponsor	Collaborator
Zhengzhou Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	90 days
Secondary	Proportion of patients functionally independent (mRS score 0 to 2) at 90 days	functional independence	Within 90 days90 days
Secondary	Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)	ambulatory or bodily needs-capable or better	90 days
Secondary	Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS)	Health-related quality of life	90 days
Secondary	Mortality within 90 days	evaluate death rate of the two treatment groups	90 days
Secondary	severe adverse events	evaluate complications and any adverse events	within 90 days
Secondary	Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria)	evaluate intracranial hemorrhage	within 72 hours after randomized
Secondary	Any type of intracerebral hemorrhage (Heidelberg Criteria)	evaluate intracranial hemorrhage	within 72 hours after randomized
Secondary	Brain edema	evaluate brain edema	within 72 hours after randomized
Secondary	Malignant Brain Edema	evaluate brain edema	within 72 hours after randomized
Secondary	Incidence of pulmonary infections	evaluate pulmonary infections	within 72 hours after randomized
Secondary	Improvement in National Institute of Health stroke scale (NIHSS) score between baseline and 5~7d	neurological changes.	at 5~7 days after randomization