Head of Bed After Ischemic Stroke Thrombectomy (HoBIT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Head of bed position of 0-degrees
Other interventionFlat 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 greater
Other interventionSemi-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.
Treatment groups
2,240 Participants
are divided into 2 treatment groupsGroup A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmOther 1 intervention
Trial outcomes
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
Time frame
90±14 days from randomizationSecondary outcomes
1
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
Time frame
Between randomization and 36±12 hours from randomization2
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
Time frame
36±12 hours from randomization, compared with randomization3
Functional impairment
Functional impairment assessed with the Modified Rankin Score (mRS) 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
Time frame
Day 7 from randomization or discharge if happens first4
Functional independence
Functional independence defined as Modified Rankin Score (mRS) of 2 or less 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
Time frame
Day 7 from randomization or discharge if happens first and 90±14 days from randomizationSponsors and contacts
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Source ClinicalTrials.gov