Large Vessel OcclusionHoBITNCT07367633
Head of Bed After Ischemic Stroke Thrombectomy (HoBIT)
A study testing Head of bed position of 0-degrees and Head of bed position of 30-degrees or greater in people with Large Vessel Occlusion and Stroke, run by Population Health Research Institute at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Vessel Occlusion, Stroke, Ischemic Stroke
- What is being tested?
- Head of bed position of 0-degrees and Head of bed position of 30-degrees or greater
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,240 participants
- Where
- 2 sitesCanada
- Study dates
- 3 Sep 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Health Sciences North
Greater Sudbury, Ontario, P3E5J1
Mythili Velma, 705-523-7100, mvelma@hsnri.ca
Aviraj Deshmukh, MD
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Kanchana Ratnayake, 905-521-2100, ratnayake@hhsc.ca
Aristeidis Katsanos, MD
About this study
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.
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
- Being tested
- Head of bed position of 0-degrees, Head of bed position of 30-degrees or greater
- Keywords
- head of bed, stroke, large vessel occlusion, endovascular thrombectomy, EVT
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head of bed position of 0-degreesOther
Also called HoB 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.
Head of bed position of 30-degrees or greaterOther
Also called HoB position of >= 30-degrees, HoB position of greater than or equal to 30-degrees, HoB position of ≥ 30-degrees
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Head of bed position of 0-degrees Receives: Other: Head of bed position of 0-degrees |
| Control Arm | Other | Head of bed position of 30-degrees or greater Receives: Other: Head of bed position of 30-degrees or greater |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90±14 days from randomization
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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".
Measured: 90±14 days from randomization
Intervention adherence
Adherence to the assigned HoB position for 24 hours from randomization, defined as >80% of total time spent in the assigned HoB
Measured: First 24 hours from randomization
Total time spent
Total time spent in the assigned HoB position
Measured: First 24 hours from randomization
Infarct volume
Infarct volume on the brain imaging (CT/ MRI) performed as part of standard clinical care
Measured: 24 +/- 12 hours from randomization and 5-7 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start3 Sep 2026
- Primary completionApr 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Vessel OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aristeidis Katsanos, MD, Principal investigator, Population Health Research InstituteMike Sharma, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367633
- Sponsor's protocol ID
- HoBIT
- Acronym
- HoBIT
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07367633
- Acronym / sponsor ID
- HoBIT / HoBIT
- Conditions
- Large Vessel Occlusion, Stroke, Ischemic Stroke
- Keywords
- head of bed, stroke, large vessel occlusion, endovascular thrombectomy, EVT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,240 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Head of bed position of 0-degreesHead of bed position of 0-degrees |
| Control Arm | Other | Other: Head of bed position of 30-degrees or greaterHead of bed position of 30-degrees or greater |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head of bed position of 0-degreesAlso: HoB position of 0-degreesFlat 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 | Intervention Arm |
| Head of bed position of 30-degrees or greaterAlso: HoB position of >= 30-degrees, HoB position of greater than or equal to 30-degrees, HoB position of ≥ 30-degreesSemi-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 | Control Arm |
Primary outcome
Functional disability
Time frame: 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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Related trials for Large Vessel Occlusion
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
Not yet recruitingPhase 3
Tenecteplase Bridging Thrombolysis Prior to Inter-hospital Transfer for Endovascular Therapy in Anterior Circulation Large Vessel Occlusion Stroke Within 4.5-24 Hours
Acute Ischemic Stroke, Large Vessel Occlusion
RecruitingPhase 3
Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke
Ischemic Stroke
Recruiting
Role of Hypothermia in Endovascular Stroke Thrombectomy
Stroke, Acute Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aristeidis Katsanos, MD principal investigator
Population Health Research Institute
Mike Sharma, MD principal investigator
Population Health Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head of bed position of 0-degrees and Head of bed position of 30-degrees or greater in people with Large Vessel Occlusion and Stroke, run by Population Health Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Block, BSc (905-521-2100, hobit@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability (time frame: 90±14 days from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.