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Набор скоро начнётся NCT07367633

Head of Bed After Ischemic Stroke Thrombectomy (HoBIT)

Без фазы С лечением Large Vessel Occlusion Stroke Ischemic Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Head of bed position of 0-degrees, Head of bed position of 30-degrees or greater.
Кому может быть актуально
Состояния в реестре: Large Vessel Occlusion, Stroke, Ischemic Stroke. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

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.

Обзор

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.

Вмешательства

  • Другое 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.
  • Другое 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.

Первичные конечные точки

  • Functional disability [Срок оценки: 90±14 days from randomization]
Вторичные конечные точки (8)
  • Absolute difference in NIHSS score [Срок оценки: Between randomization and 36±12 hours from randomization]
  • Early neurological improvement [Срок оценки: 36±12 hours from randomization, compared with randomization]
  • Functional impairment [Срок оценки: Day 7 from randomization or discharge if happens first]
  • Functional independence [Срок оценки: Day 7 from randomization or discharge if happens first and 90±14 days from randomization]
  • Quality of life assessment [Срок оценки: 90±14 days from randomization]
  • Intervention adherence [Срок оценки: First 24 hours from randomization]
  • Total time spent [Срок оценки: First 24 hours from randomization]
  • Infarct volume [Срок оценки: 24 +/- 12 hours from randomization and 5-7 days from randomization]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Канада · 1 центр
  • Hamilton General Hospital — Hamilton

Идентификаторы

NCT: NCT07367633 · HoBIT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗