A Pragmatic, Multicentre, Adaptive, Prospective, Open-label, Blinded Endpoint Randomized Clinical Trial Assessing the Impact of Head-of-bed Positioning at 0-degrees Versus 30-degrees or More on Functional Recovery Following Endovascular Thrombectomy for Anterior Circulation Large Vessel Occlusion Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,240
- 试验地点
- 1
- 主要终点
- Functional disability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention Arm
Head of bed position of 0-degrees
干预措施: Head of bed position of 0-degrees (Other)
Control Arm
Head of bed position of 30-degrees or greater
干预措施: Head of bed position of 30-degrees or greater (Other)
结局指标
主要结局
Functional disability
时间窗: 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
次要结局
- Absolute difference in NIHSS score(Between randomization and 36±12 hours from randomization)
- Early neurological improvement(36±12 hours from randomization, compared with randomization)
- Functional impairment(Day 7 from randomization or discharge if happens first)
- Total time spent(First 24 hours from randomization)
- Functional independence(Day 7 from randomization or discharge if happens first and 90±14 days from randomization)
- Quality of life assessment(90±14 days from randomization)
- Intervention adherence(First 24 hours from randomization)
- Infarct volume(24 +/- 12 hours from randomization and 5-7 days from randomization)