Capo del Letto Dopo Trombectomia per Ictus Ischemico (HoBIT) (HoBIT)
Uno Studio Clinico Randomizzato Pragmatico, Multicentrico, Adattivo, Prospettico, in Aperto con Endpoint in Cieco che Valuta l'Impatto del Posizionamento della Testiera del Letto a 0 Gradi Rispetto a 30 Gradi o Più sul Recupero Funzionale Dopo Trombectomia Endovascolare per Ictus da Occlusione di Grosso Vaso della Circolazione Anteriore.
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Samantha Block, BSc
- Numero di telefono: 905-521-2100
- Email: hobit@phri.ca
Backup dei contatti dello studio
- Nome: Amanda Taylor, BSc
- Numero di telefono: 905-521-2100
- Email: hobit@phri.ca
Luoghi di studio
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Ontario
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Greater Sudbury, Ontario, Canada, P3E5J1
- Reclutamento
- Health Sciences North
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Investigatore principale:
- Aviraj Deshmukh, MD
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Contatto:
- Mythili Velma
- Numero di telefono: 705-523-7100
- Email: mvelma@hsnri.ca
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Hamilton, Ontario, Canada, L8L 2X2
- Reclutamento
- Hamilton General Hospital
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Investigatore principale:
- Aristeidis Katsanos, MD
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Contatto:
- Kanchana Ratnayake
- Numero di telefono: 905-521-2100
- Email: ratnayake@hhsc.ca
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
|
|
Altro: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Functional disability
Lasso di tempo: 90±14 days from randomization
|
Functional disability assessed with the modified Rankin Scale (mRS) score. Scores: 0 - No symptoms
|
90±14 days from randomization
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Absolute difference in NIHSS score
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Functional impairment
Lasso di tempo: Day 7 from randomization or discharge if happens first
|
Functional impairment assessed with the Modified Rankin Score (mRS) Scores: 0 - No symptoms
|
Day 7 from randomization or discharge if happens first
|
|
Functional independence
Lasso di tempo: Day 7 from randomization or discharge if happens first and 90±14 days from randomization
|
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
Lasso di tempo: 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
Lasso di tempo: First 24 hours from randomization
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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
Lasso di tempo: First 24 hours from randomization
|
Total time spent in the assigned HoB position |
First 24 hours from randomization
|
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Infarct volume
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Aristeidis Katsanos, MD, Population Health Research Institute
- Investigatore principale: Mike Sharma, MD, Population Health Research Institute
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HoBIT
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