Head of Bed After Ischemic Stroke Thrombectomy (HoBIT) (HoBIT)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Ischemic Stroke; Large Vessel Occlusion
• Intervention / Treatment: Other: Head of bed position of 0-degrees; Other: Head of bed position of 30-degrees or greater

• Study Type: Interventional
• Enrollment (Estimated): 2240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samantha Block, BSc; Phone Number: 905-521-2100; Email: hobit@phri.ca
• Study Contact Backup: Name: Amanda Taylor, BSc; Phone Number: 905-521-2100; Email: hobit@phri.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Head of bed position of 0-degrees	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 Names: HoB position of 0-degrees
Other: Control Arm; Head of bed position of 30-degrees or greater	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.; Other Names: HoB position of >= 30-degrees; HoB position of greater than or equal to 30-degrees; HoB position of ≥ 30-degrees

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional disability	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	90±14 days from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention adherence	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	Total time spent in the assigned HoB position	First 24 hours from randomization
Infarct volume	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
Absolute difference in NIHSS score	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	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	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	Day 7 from randomization or discharge if happens first
Functional independence	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	Day 7 from randomization or discharge if happens first and 90±14 days from randomization
Quality of life assessment	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

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Investigators: Principal Investigator: Aristeidis Katsanos, MD, Population Health Research Institute; Principal Investigator: Mike Sharma, MD, Population Health Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: stroke; large vessel occlusion; endovascular thrombectomy; EVT; head of bed
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: HoBIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No