Head of Bed After Ischemic Stroke Thrombectomy (HoBIT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Head of bed position of 0-degrees, Head of bed position of 30-degrees or greater.
- Who it may be relevant to
- Registry conditions: Large Vessel Occlusion, Stroke, Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Interventions
- Other 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. - Other 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.
Primary outcome measures
- Functional disability [Time frame: 90±14 days from randomization]
Secondary outcome measures (8)
- Absolute difference in NIHSS score [Time frame: Between randomization and 36±12 hours from randomization]
- Early neurological improvement [Time frame: 36±12 hours from randomization, compared with randomization]
- Functional impairment [Time frame: Day 7 from randomization or discharge if happens first]
- Functional independence [Time frame: Day 7 from randomization or discharge if happens first and 90±14 days from randomization]
- Quality of life assessment [Time frame: 90±14 days from randomization]
- Intervention adherence [Time frame: First 24 hours from randomization]
- Total time spent [Time frame: First 24 hours from randomization]
- Infarct volume [Time frame: 24 +/- 12 hours from randomization and 5-7 days from randomization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Canada · 1 center
- Hamilton General Hospital — Hamilton
Identifiers
NCT: NCT07367633 · HoBIT