Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Sänggavelshöjning efter ischemisk stroke trombektomi (HoBIT) (HoBIT)

15 september 2026 uppdaterad av: Population Health Research Institute

En pragmatisk, multicentrisk, adaptiv, prospektiv, öppen, blindad slutpunktsrandomiserad klinisk prövning som bedömer effekten av huvudändans position vid 0 grader jämfört med 30 grader eller mer på funktionell återhämtning efter endovaskulär trombektomi för stroke med stor kärlblockering i främre cirkulationen.

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

2240

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Samantha Block, BSc
  • Telefonnummer: 905-521-2100
  • E-post: hobit@phri.ca

Studera Kontakt Backup

  • Namn: Amanda Taylor, BSc
  • Telefonnummer: 905-521-2100
  • E-post: hobit@phri.ca

Studieorter

  • Kanada
    • Ontario
      • Greater Sudbury, Ontario, Kanada, P3E5J1
        • Rekrytering
        • Health Sciences North
        • Huvudutredare:
          • Aviraj Deshmukh, MD
        • Kontakt:
      • Hamilton, Ontario, Kanada, L8L 2X2
        • Rekrytering
        • Hamilton General Hospital
        • Huvudutredare:
          • Aristeidis Katsanos, MD
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention Arm

Head of bed position of 0-degrees
Övrig: 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.

Andra namn:
  • HoB-position på 0 grader
Övrig: Control Arm

Head of bed position of 30-degrees or greater
Övrig: 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.

Andra namn:
  • HoB-position på ≥ 30 grader
  • HoB-position på större än eller lika med 30 grader

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional disability
Tidsram: 90±14 days from randomization

Functional disability assessed with the modified Rankin Scale (mRS) score.

Scores:

0 - No symptoms

  1. - No significant difficulty despite symptoms; able to carry out all usual duties and activities
  2. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. - Moderate disability; requiring some help, but able to walk without assistance
  4. - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  5. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. - Dead
90±14 days from randomization

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Absolute difference in NIHSS score
Tidsram: 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
Tidsram: 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
Tidsram: Day 7 from randomization or discharge if happens first

Functional impairment assessed with the Modified Rankin Score (mRS)

Scores:

0 - No symptoms

  1. - No significant difficulty despite symptoms; able to carry out all usual duties and activities
  2. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. - Moderate disability; requiring some help, but able to walk without assistance
  4. - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  5. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. - Dead
Day 7 from randomization or discharge if happens first
Functional independence
Tidsram: 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

  1. - No significant difficulty despite symptoms; able to carry out all usual duties and activities
  2. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. - Moderate disability; requiring some help, but able to walk without assistance
  4. - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  5. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. - Dead
Day 7 from randomization or discharge if happens first and 90±14 days from randomization
Quality of life assessment
Tidsram: 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
Intervention adherence
Tidsram: 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
Total time spent
Tidsram: First 24 hours from randomization

Total time spent in the assigned HoB position
First 24 hours from randomization
Infarct volume
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Population Health Research Institute

Utredare

  • Huvudutredare: Aristeidis Katsanos, MD, Population Health Research Institute
  • Huvudutredare: Mike Sharma, MD, Population Health Research Institute

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 september 2026

Primärt slutförande (Beräknad)

1 april 2029

Avslutad studie (Beräknad)

1 maj 2029

Studieregistreringsdatum

Först inskickad

17 januari 2026

Först inskickad som uppfyllde QC-kriterierna

17 januari 2026

Första postat (Faktisk)

26 januari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HoBIT

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera