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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Head of bed position of 0-degrees |
|
| Control Arm | Other | Head of bed position of 30-degrees or greater |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional disability | Functional disability assessed with the modified Rankin Scale (mRS) score. Scores: 0 - No symptoms
| 90±14 days from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Between randomization and 36±12 hours from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Block, BSc | Contact | 905-521-2100 | hobit@phri.ca | |
| Amanda Taylor, BSc | Contact | 905-521-2100 | hobit@phri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Aristeidis Katsanos, MD | Population Health Research Institute | Principal Investigator |
| Mike Sharma, MD | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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. |
|
|
| 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 |
| 36±12 hours from randomization, compared with randomization |
| Functional impairment | Functional impairment assessed with the Modified Rankin Score (mRS) Scores: 0 - No symptoms
| 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
| 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". | 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 | First 24 hours from randomization |
| Total time spent | Total time spent in the assigned HoB position | First 24 hours from randomization |
| Infarct volume | Infarct volume on the brain imaging (CT/ MRI) performed as part of standard clinical care | 24 +/- 12 hours from randomization and 5-7 days from randomization |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |