Clinical trial NCT06115707: Head Position After Endovascular Therapy
Official title: Head Positioning After Endovascular Therapy for Acute Ischemic Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Endovascular Therapy
Lead sponsor: The Affiliated Hospital Of Southwest Medical University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 1332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Clinical signs consistent with acute ischemic stroke;
2. Age ≥ 18 years old;
3. Proved anterior circulation 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 acute 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. Contraindications to a flat head position;
5. Any terminal illness with life expectancy less than 6 months;
6. Participating in other clinical trials;
7. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
8. Unlikely to be available for 90-day follow-up.

Primary outcomes:
measure: Modified Rankin scale score (mRS)
timeFrame: 90 days
Secondary outcomes:
measure: 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)
timeFrame: 90 days
measure: Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
timeFrame: Within 90 days90 days
measure: Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)
timeFrame: 90 days
measure: Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS)
timeFrame: 90 days
measure: Mortality within 90 days
timeFrame: 90 days
measure: severe adverse events
timeFrame: within 90 days
measure: Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria)
timeFrame: within 72 hours after randomized
measure: Any type of intracerebral hemorrhage (Heidelberg Criteria)
timeFrame: within 72 hours after randomized
measure: Brain edema
timeFrame: within 72 hours after randomized
measure: Malignant Brain Edema
timeFrame: within 72 hours after randomized
measure: Incidence of pulmonary infections
timeFrame: within 72 hours after randomized
measure: Improvement in National Institute of Health stroke scale (NIHSS) score between baseline and 5~7d
timeFrame: at 5~7 days after randomization
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Banan District People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Bishan District People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Ninth People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Yongchuan Hospital Affiliated to Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Longyan
country: China
facility: Longyan First Hospital
state: Fujian
city: Dingxi
country: China
facility: Dingxi People's Hospital
state: Gansu
city: Jiuquan
country: China
facility: Jiuquan People's Hospital
state: Gansu
city: Lanzhou
country: China
facility: Gansu Provincial Hospital of Traditional Chinese Medicine
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou University First Hospital
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Tianshui
country: China
facility: Tianshui First People's Hospital
state: Gansu
city: Guanzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Heyuan
country: China
facility: Guangdong Provincial People's Hospital Heyuan Hospital
state: Guangdong
city: Baise
country: China
facility: Baise People's Hospital
state: Guangxi
city: Nanning
country: China
facility: Nanning Third People's Hospital
state: Guangxi
city: Dujun
country: China
facility: Qiannan Prefecture People's Hospital
state: Guizhou
city: Xingyi
country: China
facility: Xingyi People's Hospital
state: Guizhou
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical College
state: Hainan
city: Jiamusi
country: China
facility: Jiamusi Central Hospital
state: Heilongjiang
city: Yichun
country: China
facility: Yichun First Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Anyang People's Hospital
state: Henan
city: Zhoukou
country: China
facility: Xihua County People's Hospital
state: Henan
city: Shiyan
country: China
facility: Shiyan taihe hospital
state: Hubei
city: Changsha
country: China
facility: Ningxiang First People's Hospital
state: Hunan
city: Chenzhou
country: China
facility: The First People's Hospital of Chenzhou City
state: Hunan
city: GanZhou
country: China
facility: Ganzhou Municipal Hospital
state: Jiangxi
city: Ganzhou
country: China
facility: Ganzhou People's Hospital
state: Jiangxi
city: Ganzhou
country: China
facility: Xingguo County People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian 967 Hospital
state: Liaoning
city: Yinchuan
country: China
facility: Ningxia Hui Autonomous Region People's Hospital
state: Ningxia
city: Xining
country: China
facility: The Fifth People's Hospital of Qinghai Province
state: Qinghai
city: Baoji
country: China
facility: Baoji High tech Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Northwest University Affiliated Hospital
state: Shaanxi
city: Xianyang
country: China
facility: Xianyang First People's Hospital
state: Shaanxi
city: Yulin
country: China
facility: Yulin First Hospital
state: Shaanxi
city: Rizhao
country: China
facility: Rizhao Traditional Chinese Medicine Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Provincial Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xidian Group Hospital
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Sixth People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chongzhou People's Hospital
state: Sichuan
city: Deyang
country: China
facility: Deyang People's Hospital
state: Sichuan
city: Guangyuan
country: China
facility: Guangyuan First People's Hospital
state: Sichuan
city: Luzhou
country: China
facility: Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Luzhou
country: China
facility: Gulin County People's Hospital
state: Sichuan
city: Mianyang
country: China
facility: Beichuan County People's Hospital
state: Sichuan
city: Mianyang
country: China
facility: Mianyang 404 Hospital
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Central Hospital
state: Sichuan
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
city: Neijiang
country: China
facility: Neijiang Second People's Hospital
state: Sichuan
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Suining
country: China
facility: Suining First People's Hospital
state: Sichuan
city: Xichang
country: China
facility: Liangshan First People's Hospital
state: Sichuan
city: Xichang
country: China
facility: Xichang People's Hospital
state: Sichuan
city: Ya'an
country: China
facility: Ya'an People's Hospital
state: Sichuan
city: Yibin
country: China
facility: Yibin Second People's Hospital
state: Sichuan
city: Zigong
country: China
facility: Fushun County People's Hospital
state: Sichuan
city: Zigong
country: China
facility: Zigong First People's Hospital
state: Sichuan
city: Zigong
country: China
facility: Zigong Fourth People's Hospital
state: Sichuan
city: Zigong
country: China
facility: Zigong Third People's Hospital
state: Sichuan
city: Ürümqi
country: China
facility: The Seventh Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Qujing
country: China
facility: Qujing First People's Hospital
state: Yunnan
city: Wenzhou
country: China
facility: Wenzhou Medical University First Affiliated Hospital
state: Zhejiang
Study officials:
affiliation: Affiliated Hospital of Southwest Medical University
name: Zhengzhou Yuan
role: STUDY_CHAIR
affiliation: Affiliated Hospital of Southwest Medical University
name: Yong Jiang
role: STUDY_CHAIR
References: