Oberkörperhochlagerung nach ischämischem Schlaganfall-Thrombektomie (HoBIT) (HoBIT)
Eine pragmatische, multizentrische, adaptive, prospektive, offene, mit verblindetem Endpunkt randomisierte klinische Studie zur Bewertung der Auswirkungen der Kopfteilpositionierung bei 0 Grad im Vergleich zu 30 Grad oder mehr auf die funktionelle Erholung nach endovaskulärer Thrombektomie bei Schlaganfall aufgrund eines Verschlusses großer Gefäße im vorderen Kreislauf.
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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Samantha Block, BSc
- Telefonnummer: 905-521-2100
- E-Mail: hobit@phri.ca
Studieren Sie die Kontaktsicherung
- Name: Amanda Taylor, BSc
- Telefonnummer: 905-521-2100
- E-Mail: hobit@phri.ca
Studienorte
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Ontario
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Greater Sudbury, Ontario, Kanada, P3E5J1
- Rekrutierung
- Health Sciences North
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Hauptermittler:
- Aviraj Deshmukh, MD
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Kontakt:
- Mythili Velma
- Telefonnummer: 705-523-7100
- E-Mail: mvelma@hsnri.ca
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Hamilton, Ontario, Kanada, L8L 2X2
- Rekrutierung
- Hamilton General Hospital
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Hauptermittler:
- Aristeidis Katsanos, MD
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Kontakt:
- Kanchana Ratnayake
- Telefonnummer: 905-521-2100
- E-Mail: ratnayake@hhsc.ca
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
Andere Namen:
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Sonstiges: 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Functional disability
Zeitfenster: 90±14 days from randomization
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Functional disability assessed with the modified Rankin Scale (mRS) score. Scores: 0 - No symptoms
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90±14 days from randomization
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Absolute difference in NIHSS score
Zeitfenster: Between randomization and 36±12 hours from randomization
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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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Early neurological improvement
Zeitfenster: 36±12 hours from randomization, compared with randomization
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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
Zeitfenster: 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
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Day 7 from randomization or discharge if happens first
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Functional independence
Zeitfenster: 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
Zeitfenster: 90±14 days from randomization
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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
Zeitfenster: 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
Zeitfenster: First 24 hours from randomization
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Total time spent in the assigned HoB position |
First 24 hours from randomization
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Infarct volume
Zeitfenster: 24 +/- 12 hours from randomization and 5-7 days from randomization
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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
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Aristeidis Katsanos, MD, Population Health Research Institute
- Hauptermittler: Mike Sharma, MD, Population Health Research Institute
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HoBIT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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