Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:05 AM
Study NCT ID:
NCT07367633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2026-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head of Bed After Ischemic Stroke Thrombectomy (HoBIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2240}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-01-17', 'studyFirstSubmitQcDate': '2026-01-17', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional disability', 'timeFrame': '90±14 days from randomization', 'description': 'Functional disability assessed with the modified Rankin Scale (mRS) score.\n\nScores:\n\n0 - No symptoms\n\n1. \\- No significant difficulty despite symptoms; able to carry out all usual duties and activities\n2. \\- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance\n3. \\- Moderate disability; requiring some help, but able to walk without assistance\n4. \\- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance\n5. \\- Severe disability; bedridden, incontinent and requiring constant nursing care and attention\n6. \\- Dead'}], 'secondaryOutcomes': [{'measure': 'Absolute difference in NIHSS score', 'timeFrame': 'Between randomization and 36±12 hours from randomization', 'description': 'Absolute difference in the National Institutes of Health Stroke Scale (NIHSS) scores\n\nScores:\n\n0 - No stroke symptoms 1-4 - Minor stroke 5-15 - Moderate stroke 16-20 - Moderate to severe stroke 21-42 - Severe stroke'}, {'measure': 'Early neurological improvement', 'timeFrame': '36±12 hours from randomization, compared with randomization', 'description': 'Early neurological improvement, defined as an absolute decrease of the National Institutes of Health Stroke Scale (NIHSS) score by 4 points or more\n\nScores:\n\n0 - No stroke symptoms 1-4 - Minor stroke 5-15 - Moderate stroke 16-20 - Moderate to severe stroke 21-42 - Severe stroke'}, {'measure': 'Functional impairment', 'timeFrame': 'Day 7 from randomization or discharge if happens first', 'description': 'Functional impairment assessed with the Modified Rankin Score (mRS)\n\nScores:\n\n0 - No symptoms\n\n1. \\- No significant difficulty despite symptoms; able to carry out all usual duties and activities\n2. \\- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance\n3. \\- Moderate disability; requiring some help, but able to walk without assistance\n4. \\- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance\n5. \\- Severe disability; bedridden, incontinent and requiring constant nursing care and attention\n6. \\- Dead'}, {'measure': 'Functional independence', 'timeFrame': 'Day 7 from randomization or discharge if happens first and 90±14 days from randomization', 'description': 'Functional independence defined as Modified Rankin Score (mRS) of 2 or less\n\nScores:\n\n0 - No symptoms\n\n1. \\- No significant difficulty despite symptoms; able to carry out all usual duties and activities\n2. \\- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance\n3. \\- Moderate disability; requiring some help, but able to walk without assistance\n4. \\- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance\n5. \\- Severe disability; bedridden, incontinent and requiring constant nursing care and attention\n6. \\- Dead'}, {'measure': 'Quality of life assessment', 'timeFrame': '90±14 days from randomization', 'description': '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".'}, {'measure': 'Intervention adherence', 'timeFrame': 'First 24 hours from randomization', 'description': 'Adherence to the assigned HoB position for 24 hours from randomization, defined as \\>80% of total time spent in the assigned HoB'}, {'measure': 'Total time spent', 'timeFrame': 'First 24 hours from randomization', 'description': 'Total time spent in the assigned HoB position'}, {'measure': 'Infarct volume', 'timeFrame': '24 +/- 12 hours from randomization and 5-7 days from randomization', 'description': 'Infarct volume on the brain imaging (CT/ MRI) performed as part of standard clinical care'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['head of bed', 'stroke', 'large vessel occlusion', 'endovascular thrombectomy', 'EVT'], 'conditions': ['Large Vessel Occlusion', 'Stroke', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older on the date of randomization\n* 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)\n* 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.\n\nExclusion Criteria:\n\n* Mechanical ventilatory support for acute medical condition prior to procedure (i.e. required for reasons other than procedure)\n* 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.\n* 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\n* Any condition with life expectancy of less than 3 months\n* Inability to randomize within 1 hour from the end of the EVT'}, 'identificationModule': {'nctId': 'NCT07367633', 'acronym': 'HoBIT', 'briefTitle': 'Head of Bed After Ischemic Stroke Thrombectomy (HoBIT)', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'HoBIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Head of bed position of 0-degrees', 'interventionNames': ['Other: Head of bed position of 0-degrees']}, {'type': 'OTHER', 'label': 'Control Arm', 'description': 'Head of bed position of 30-degrees or greater', 'interventionNames': ['Other: Head of bed position of 30-degrees or greater']}], 'interventions': [{'name': 'Head of bed position of 0-degrees', 'type': 'OTHER', 'otherNames': ['HoB position of 0-degrees'], 'description': '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.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Head of bed position of 30-degrees or greater', 'type': 'OTHER', 'otherNames': ['HoB position of >= 30-degrees', 'HoB position of greater than or equal to 30-degrees', 'HoB position of ≥ 30-degrees'], 'description': "Semi-recumbent position with the HoB to at least 30 degrees for a continuous 24-hour period.\n\nHead and torso must remain elevated at 30 degrees or higher, using the hospital bed's positioning system.", 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Samantha Block, BSc', 'role': 'CONTACT', 'email': 'hobit@phri.ca', 'phone': '905-521-2100'}, {'name': 'Amanda Taylor, BSc', 'role': 'CONTACT', 'email': 'hobit@phri.ca', 'phone': '905-521-2100'}], 'overallOfficials': [{'name': 'Aristeidis Katsanos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Population Health Research Institute'}, {'name': 'Mike Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Population Health Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}