Head of Bed After Ischemic Stroke Thrombectomy (HoBIT)

Population Health Research Institute (PHRI)

Status: Begins enrollment this month

Conditions: Ischemic Stroke; Stroke; Large Vessel Occlusion

Treatments: Other: Head of bed position of 30-degrees or greater; Other: Head of bed position of 0-degrees

Study type: Interventional

Funder types: Other

Identifiers

NCT07367633

HoBIT

Details and patient eligibility

About

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.

Enrollment: 2,240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,240 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Head of bed position of 0-degrees

Treatment:

Other: Head of bed position of 0-degrees

Control Arm

Other group

Description:

Head of bed position of 30-degrees or greater

Treatment:

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