Head Position After Endovascular Therapy

Last updated: October 20, 2024
Sponsor: Zhengzhou Yuan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Claudication

Treatment

The lying flat (0°) head position for 72 hours

The lying flat (0°-10°) head position for 72 hours

The The head elevation (30°) position for 72 hours

Clinical Study ID

NCT06115707
SWMU202305
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinical signs consistent with acute ischemic stroke;

  2. Age ≥ 18 years old;

  3. Proved anterior circulation large vessel occlusion on digital subtractionangiography (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 eTICIscore of 2b, 2c, or 3) ;

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

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

Exclusion

Exclusion Criteria:

  1. Pre-stroke mRS score>1 point;

  2. Patients with acute occlusions in multiple vascular territories (e.g. bilateralanterior 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 confoundthe neurological functional evaluations;

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

Study Design

Total Participants: 1332
Treatment Group(s): 4
Primary Treatment: The lying flat (0°) head position for 72 hours
Phase:
Study Start date:
November 13, 2023
Estimated Completion Date:
April 20, 2026

Study 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.

Connect with a study center

  • Chongqing Banan District People's Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Chongqing Bishan District People's Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Chongqing Ninth People's Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Yongchuan Hospital Affiliated to Chongqing Medical University

    Chongqing, Chongqing
    China

    Active - Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Longyan First Hospital

    Longyan, Fujian 364099
    China

    Active - Recruiting

  • Dingxi People's Hospital

    Dingxi, Gansu
    China

    Active - Recruiting

  • Jiuquan People's Hospital

    Jiuquan, Gansu
    China

    Active - Recruiting

  • Gansu Provincial Hospital of Traditional Chinese Medicine

    Lanzhou, Gansu
    China

    Active - Recruiting

  • Lanzhou University First Hospital

    Lanzhou, Gansu
    China

    Active - Recruiting

  • Lanzhou University Second Hospital

    Lanzhou, Gansu
    China

    Active - Recruiting

  • Tianshui First People's Hospital

    Tianshui, Gansu
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guanzhou, Guangdong
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital Heyuan Hospital

    Heyuan, Guangdong
    China

    Active - Recruiting

  • Baise People's Hospital

    Baise, Guangxi
    China

    Active - Recruiting

  • Nanning Third People's Hospital

    Nanning, Guangxi
    China

    Active - Recruiting

  • Qiannan Prefecture People's Hospital

    Dujun, Guizhou
    China

    Active - Recruiting

  • Xingyi People's Hospital

    Xingyi, Guizhou
    China

    Active - Recruiting

  • The First Affiliated Hospital of Hainan Medical College

    Haikou, Hainan
    China

    Active - Recruiting

  • Jiamusi Central Hospital

    Jiamusi, Heilongjiang
    China

    Active - Recruiting

  • Yichun First Hospital

    Yichun, Heilongjiang
    China

    Active - Recruiting

  • Anyang People's Hospital

    Anyang, Henan
    China

    Active - Recruiting

  • Xihua County People's Hospital

    Zhoukou, Henan
    China

    Active - Recruiting

  • Shiyan taihe hospital

    Shiyan, Hubei
    China

    Active - Recruiting

  • Ningxiang First People's Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • The First People's Hospital of Chenzhou City

    Chenzhou, Hunan
    China

    Active - Recruiting

  • Ganzhou Municipal Hospital

    GanZhou, Jiangxi
    China

    Active - Recruiting

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi
    China

    Active - Recruiting

  • Xingguo County People's Hospital

    Ganzhou, Jiangxi
    China

    Active - Recruiting

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Active - Recruiting

  • Dalian 967 Hospital

    Dalian, Liaoning
    China

    Active - Recruiting

  • Ningxia Hui Autonomous Region People's Hospital

    Yinchuan, Ningxia
    China

    Active - Recruiting

  • The Fifth People's Hospital of Qinghai Province

    Xining, Qinghai
    China

    Active - Recruiting

  • Baoji High tech Hospital

    Baoji, Shaanxi
    China

    Active - Recruiting

  • Northwest University Affiliated Hospital

    Xi'an, Shaanxi
    China

    Active - Recruiting

  • Xianyang First People's Hospital

    Xianyang, Shaanxi
    China

    Active - Recruiting

  • Yulin First Hospital

    Yulin, Shaanxi
    China

    Active - Recruiting

  • Rizhao Traditional Chinese Medicine Hospital

    Rizhao, Shandong
    China

    Active - Recruiting

  • Shanxi Provincial Hospital

    Taiyuan, Shanxi
    China

    Active - Recruiting

  • Xidian Group Hospital

    Xi'an, Shanxi
    China

    Active - Recruiting

  • Chengdu Sixth People's Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • Chongzhou People's Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • Deyang People's Hospital

    Deyang, Sichuan
    China

    Active - Recruiting

  • Guangyuan First People's Hospital

    Guangyuan, Sichuan
    China

    Active - Recruiting

  • Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan 646000
    China

    Active - Recruiting

  • Gulin County People's Hospital

    Luzhou, Sichuan
    China

    Active - Recruiting

  • Beichuan County People's Hospital

    Mianyang, Sichuan
    China

    Active - Recruiting

  • Mianyang 404 Hospital

    Mianyang, Sichuan
    China

    Active - Recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan
    China

    Active - Recruiting

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan
    China

    Active - Recruiting

  • Neijiang Second People's Hospital

    Neijiang, Sichuan
    China

    Active - Recruiting

  • Suining Central Hospital

    Suining, Sichuan
    China

    Active - Recruiting

  • Suining First People's Hospital

    Suining, Sichuan
    China

    Active - Recruiting

  • Liangshan First People's Hospital

    Xichang, Sichuan
    China

    Active - Recruiting

  • Xichang People's Hospital

    Xichang, Sichuan
    China

    Active - Recruiting

  • Ya'an People's Hospital

    Ya'an, Sichuan
    China

    Active - Recruiting

  • Yibin Second People's Hospital

    Yibin, Sichuan
    China

    Active - Recruiting

  • Fushun County People's Hospital

    Zigong, Sichuan
    China

    Active - Recruiting

  • Zigong First People's Hospital

    Zigong, Sichuan
    China

    Active - Recruiting

  • Zigong Fourth People's Hospital

    Zigong, Sichuan
    China

    Active - Recruiting

  • Zigong Third People's Hospital

    Zigong, Sichuan
    China

    Active - Recruiting

  • The Seventh Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang
    China

    Active - Recruiting

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan
    China

    Active - Recruiting

  • Qujing First People's Hospital

    Qujing, Yunnan
    China

    Active - Recruiting

  • Wenzhou Medical University First Affiliated Hospital

    Wenzhou, Zhejiang
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu,
    China

    Site Not Available

  • Xinqiao Hospital

    Chongqing,
    China

    Site Not Available

  • The 903rd Hospital of The Chinese People's Liberation Army

    Hangzhou,
    China

    Site Not Available

  • Wuhan No. 1 Hospital

    Wuhan,
    China

    Site Not Available

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