Jefe de Cama Después de Trombectomía por Accidente Cerebrovascular Isquémico (HoBIT) (HoBIT)
Un Ensayo Clínico Pragmático, Multicéntrico, Adaptativo, Prospectivo, de Etiqueta Abierta y Punto Final Ciego Aleatorizado que Evalúa el Impacto del Posicionamiento de la Cabecera de la Cama a 0 Grados Frente a 30 Grados o Más en la Recuperación Funcional Tras la Trombectomía Endovascular para el Ictus por Oclusión de Gran Vaso de la Circulación Anterior.
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Samantha Block, BSc
- Número de teléfono: 905-521-2100
- Correo electrónico: hobit@phri.ca
Copia de seguridad de contactos de estudio
- Nombre: Amanda Taylor, BSc
- Número de teléfono: 905-521-2100
- Correo electrónico: hobit@phri.ca
Ubicaciones de estudio
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Ontario
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Greater Sudbury, Ontario, Canadá, P3E5J1
- Reclutamiento
- Health Sciences North
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Investigador principal:
- Aviraj Deshmukh, MD
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Contacto:
- Mythili Velma
- Número de teléfono: 705-523-7100
- Correo electrónico: mvelma@hsnri.ca
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Hamilton, Ontario, Canadá, L8L 2X2
- Reclutamiento
- Hamilton General Hospital
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Investigador principal:
- Aristeidis Katsanos, MD
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Contacto:
- Kanchana Ratnayake
- Número de teléfono: 905-521-2100
- Correo electrónico: ratnayake@hhsc.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Arm
Head of bed position of 0-degrees |
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.
Otros nombres:
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Otro: Control Arm
Head of bed position of 30-degrees or greater |
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional disability
Periodo de tiempo: 90±14 days from randomization
|
Functional disability assessed with the modified Rankin Scale (mRS) score. Scores: 0 - No symptoms
|
90±14 days from randomization
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Absolute difference in NIHSS score
Periodo de tiempo: Between randomization and 36±12 hours from randomization
|
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
|
|
Early neurological improvement
Periodo de tiempo: 36±12 hours from randomization, compared with randomization
|
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
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Functional impairment
Periodo de tiempo: Day 7 from randomization or discharge if happens first
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Functional impairment assessed with the Modified Rankin Score (mRS) Scores: 0 - No symptoms
|
Day 7 from randomization or discharge if happens first
|
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Functional independence
Periodo de tiempo: Day 7 from randomization or discharge if happens first and 90±14 days from randomization
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Functional independence defined as Modified Rankin Score (mRS) of 2 or less Scores: 0 - No symptoms
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Day 7 from randomization or discharge if happens first and 90±14 days from randomization
|
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Quality of life assessment
Periodo de tiempo: 90±14 days from randomization
|
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
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Intervention adherence
Periodo de tiempo: First 24 hours from randomization
|
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
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Total time spent
Periodo de tiempo: First 24 hours from randomization
|
Total time spent in the assigned HoB position |
First 24 hours from randomization
|
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Infarct volume
Periodo de tiempo: 24 +/- 12 hours from randomization and 5-7 days from randomization
|
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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Aristeidis Katsanos, MD, Population Health Research Institute
- Investigador principal: Mike Sharma, MD, Population Health Research Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HoBIT
Información sobre medicamentos y dispositivos, documentos del estudio
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