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缺血性卒中血栓切除术后床头高度（HoBIT） (HoBIT)

2026年9月15日 更新者：Population Health Research Institute

一项实用、多中心、适应性、前瞻性、开放标签、终点盲法随机临床试验，评估0度与30度或更高床头抬高位置对前循环大血管闭塞性卒中血管内取栓术后功能恢复的影响。

Endovascular thrombectomy (EVT), also known as clot retrieval, is a procedure that improves recovery for people who suffer a stroke by removing blood clots from large blood vessels in the brain. However, half of the patients undergoing EVT to remove the clot from a brain vessel still face lasting disabilities or even die within three months.

The investigators of the HoBIT trial are trying to find out if the position of the head of bed improves recovery in patients who undergo EVT after suffering from a stroke.

The purpose of this study is to establish the benefit of head of bed positioning at 0-degrees compared with 30-degrees or more after EVT for improving functional outcomes in adults that suffer from a stroke.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

2240

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Samantha Block, BSc
  • 电话号码：905-521-2100
  • 邮箱：hobit@phri.ca

研究联系人备份

  • 姓名：Amanda Taylor, BSc
  • 电话号码：905-521-2100
  • 邮箱：hobit@phri.ca

学习地点

  • 加拿大
    • Ontario
      • Greater Sudbury、Ontario、加拿大、P3E5J1
        • 招聘中
        • Health Sciences North
        • 首席研究员：
          • Aviraj Deshmukh, MD
        • 接触：
      • Hamilton、Ontario、加拿大、L8L 2X2
        • 招聘中
        • Hamilton General Hospital
        • 首席研究员：
          • Aristeidis Katsanos, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18 years or older on the date of randomization
  • Endovascular thrombectomy (EVT) for large vessel occlusion (LVO) in the anterior circulation, according to current guidelines and local standards of clinical care. The definition of LVO may include the intracranial segment of the internal carotid artery (ICA), and/ or the M1 segment (proximal, mid, distal) of the middle cerebral artery (M1-MCA), and/ or the proximal M2 segment of the MCA (M2-MCA)
  • Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR), or via a deferred consent process approved by the relevant ethics committee, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

  • Mechanical ventilatory support for acute medical condition prior to procedure (i.e. required for reasons other than procedure)
  • Symptomatic congestive heart failure, chronic obstructive pulmonary disease, or any other medical condition that would make either HoB position inappropriate for patient care in the judgement of the investigator.
  • Any condition, such as but not limited to, agitation/ delirium or severe nausea/ vomiting, that, in the view of the investigator, is expected to significantly impede maintaining the assigned HoB
  • Any condition with life expectancy of less than 3 months
  • Inability to randomize within 1 hour from the end of the EVT

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention Arm

Head of bed position of 0-degrees
其他：Head of bed position of 0-degrees

Flat position with the HoB at 0° elevation for a continuous 24-hour period. Turning to the side (left or right) is permitted, as long as there is no head elevation.

其他名称：
  • 0度头低脚高位
其他：Control Arm

Head of bed position of 30-degrees or greater
其他：Head of bed position of 30-degrees or greater

Semi-recumbent position with the HoB to at least 30 degrees for a continuous 24-hour period.

Head and torso must remain elevated at 30 degrees or higher, using the hospital bed's positioning system.

其他名称：
  • 床头抬高角度≥30度
  • HoB 位置大于或等于 30 度
  • HoB 位置 ≥ 30 度

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Functional disability
大体时间：90±14 days from randomization

Functional disability assessed with the modified Rankin Scale (mRS) score.

Scores:

0 - No symptoms

  1. - No significant difficulty despite symptoms; able to carry out all usual duties and activities
  2. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. - Moderate disability; requiring some help, but able to walk without assistance
  4. - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  5. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. - Dead
90±14 days from randomization

次要结果测量

结果测量
措施说明
大体时间
Absolute difference in NIHSS score
大体时间：Between randomization and 36±12 hours from randomization

Absolute difference in the National Institutes of Health Stroke Scale (NIHSS) scores

Scores:

0 - No stroke symptoms 1-4 - Minor stroke 5-15 - Moderate stroke 16-20 - Moderate to severe stroke 21-42 - Severe stroke
Between randomization and 36±12 hours from randomization
Early neurological improvement
大体时间：36±12 hours from randomization, compared with randomization

Early neurological improvement, defined as an absolute decrease of the National Institutes of Health Stroke Scale (NIHSS) score by 4 points or more

Scores:

0 - No stroke symptoms 1-4 - Minor stroke 5-15 - Moderate stroke 16-20 - Moderate to severe stroke 21-42 - Severe stroke
36±12 hours from randomization, compared with randomization
Functional impairment
大体时间：Day 7 from randomization or discharge if happens first

Functional impairment assessed with the Modified Rankin Score (mRS)

Scores:

0 - No symptoms

  1. - No significant difficulty despite symptoms; able to carry out all usual duties and activities
  2. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. - Moderate disability; requiring some help, but able to walk without assistance
  4. - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  5. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. - Dead
Day 7 from randomization or discharge if happens first
Functional independence
大体时间：Day 7 from randomization or discharge if happens first and 90±14 days from randomization

Functional independence defined as Modified Rankin Score (mRS) of 2 or less

Scores:

0 - No symptoms

  1. - No significant difficulty despite symptoms; able to carry out all usual duties and activities
  2. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. - Moderate disability; requiring some help, but able to walk without assistance
  4. - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  5. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. - Dead
Day 7 from randomization or discharge if happens first and 90±14 days from randomization
Quality of life assessment
大体时间：90±14 days from randomization

Quality of life assessed with the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scores range from 1 (full health) to 0 (dead), with negative values indicating states that are "worse than dead".
90±14 days from randomization
Intervention adherence
大体时间：First 24 hours from randomization

Adherence to the assigned HoB position for 24 hours from randomization, defined as >80% of total time spent in the assigned HoB
First 24 hours from randomization
Total time spent
大体时间：First 24 hours from randomization

Total time spent in the assigned HoB position
First 24 hours from randomization
Infarct volume
大体时间：24 +/- 12 hours from randomization and 5-7 days from randomization

Infarct volume on the brain imaging (CT/ MRI) performed as part of standard clinical care
24 +/- 12 hours from randomization and 5-7 days from randomization

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Population Health Research Institute

调查人员

  • 首席研究员：Aristeidis Katsanos, MD、Population Health Research Institute
  • 首席研究员：Mike Sharma, MD、Population Health Research Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月3日

初级完成 (估计的)

2029年4月1日

研究完成 (估计的)

2029年5月1日

研究注册日期

首次提交

2026年1月17日

首先提交符合 QC 标准的

2026年1月17日

首次发布 (实际的)

2026年1月26日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HoBIT

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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