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NCT Number: NCT07367633

Head of Bed After Ischemic Stroke Thrombectomy (HoBIT)

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.

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Key information

Conditions

Large Vessel Occlusion Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Head of bed position of 0-degrees

Other

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 names: HoB position of 0-degrees

Head of bed position of 30-degrees or greater

Other

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.

Other names: HoB position of >= 30-degrees, HoB position of greater than or equal to 30-degrees, HoB position of ≥ 30-degrees

Primary outcomes

  1. Functional disability

    Time frame: 90±14 days from randomization

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

    Scores:

    0 - No symptoms

    • - No significant difficulty despite symptoms; able to carry out all usual duties and activities
    • - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • - Moderate disability; requiring some help, but able to walk without assistance
    • - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • - Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • - Dead

Secondary outcomes

  1. Absolute difference in NIHSS score

    Time frame: 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

  2. Early neurological improvement

    Time frame: 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

  3. Functional impairment

    Time frame: Day 7 from randomization or discharge if happens first

    Functional impairment assessed with the Modified Rankin Score (mRS)

    Scores:

    0 - No symptoms

    • - No significant difficulty despite symptoms; able to carry out all usual duties and activities
    • - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • - Moderate disability; requiring some help, but able to walk without assistance
    • - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • - Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • - Dead

  4. Functional independence

    Time frame: 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

    • - No significant difficulty despite symptoms; able to carry out all usual duties and activities
    • - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • - Moderate disability; requiring some help, but able to walk without assistance
    • - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • - Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • - Dead

  5. Quality of life assessment

    Time frame: 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".

  6. Intervention adherence

    Time frame: 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

  7. Total time spent

    Time frame: First 24 hours from randomization

    Total time spent in the assigned HoB position

  8. Infarct volume

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Taylor, BSc

CONTACT

[email protected]

905-521-2100

Samantha Block, BSc

CONTACT

[email protected]

905-521-2100

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study 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.

Acronym: HoBIT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 26, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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