Head of Bed After Ischemic Stroke Thrombectomy (HoBIT)

N/ANot Yet RecruitingNCT07367633

Population Health Research Institute2,240 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

2,240

Conditions

Large Vessel Occlusion Stroke Ischemic Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 randomization

Secondary Outcomes

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 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

Time frame: 36±12 hours from randomization, compared with randomization

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 first

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 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".

Time frame: 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

Time frame: First 24 hours from randomization

Total time spent

Total time spent in the assigned HoB position

Time frame: First 24 hours from randomization

Infarct volume

Infarct volume on the brain imaging (CT/ MRI) performed as part of standard clinical care

Time frame: 24 +/- 12 hours from randomization and 5-7 days from randomization