Head of Bed After Ischemic Stroke Thrombectomy (HoBIT)

NCT07367633 | Not Yet Recruiting DMC

• 1 other identifier: HoBIT
• Study Type: interventional
• Target: 2,240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Large Vessel Occlusion; Stroke; Ischemic Stroke

Keywords

head of bed; stroke; large vessel occlusion; endovascular thrombectomy; EVT

Outcome Measures

Primary Outcomes (1)

• Functional disability

  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

Secondary Outcomes (8)

• 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

• 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

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Head of bed position of 0-degrees

Other: Head of bed position of 0-degrees

Control Arm

OTHER

Head of bed position of 30-degrees or greater

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

Interventions

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.

Also known as: HoB position of >= 30-degrees, HoB position of greater than or equal to 30-degrees, HoB position of ≥ 30-degrees

Control Arm

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.

Also known as: HoB position of 0-degrees

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aristeidis Katsanos, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Mike Sharma, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Block, BSc

CONTACT

905-521-2100; hobit@phri.ca

Amanda Taylor, BSc

CONTACT

905-521-2100; hobit@phri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 26, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CA (1)