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Набор скоро начнётся NCT03484936

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage

Без фазы С лечением Intracranial Hemorrhages

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: Remote ischemic conditioning, Sham remote ischemic conditioning.
Кому может быть актуально
Состояния в реестре: Intracranial Hemorrhages. 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
Китай
Следующий шаг
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Обзор

The purpose of this study is to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.

Подробное описание

Intracerebral hemorrhage is a devastating disease with a high rate of severe disability and death, while no specific treatment has been proven to improve functional outcome. As a result, new approaches need to be developed to treat intracerebral hemorrhage. Animal and human trials showed treatment with remote ischemic conditioning was safe for intracerebral hemorrhage. And repetitive remote ischemic conditioning has been shown to improve sensorimotor and neuropathological outcomes following experimental hemorrhagic stroke. Therefore, we hypothesize that repetitive remote ischemic conditioning could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled double-blind trial to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.

Вмешательства

  • Процедура Remote ischemic conditioning
    Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days.
  • Процедура Sham remote ischemic conditioning
    Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.

Первичные конечные точки

  • Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [Срок оценки: 3 months]
Вторичные конечные точки (1)
  • Frequency of adverse events [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Supratentorial intracerebral hemorrhage confirmed by brain CT scan
  • Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
  • NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
  • Able to commence RIC treatment within 12 hours of stroke onset
  • Signed and dated informed consent is obtained.

Критерии исключения

  • Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
  • A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
  • Already booked for surgical treatment
  • Life expectancy of less than 90 days due to comorbid conditions
  • Severe hematologic disease
  • Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban.
  • Concurrent use of glibenclamide or nicorandil
  • Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC
  • Severe hepatic and renal dysfunction
  • Platelet count <100×10\^9/L
  • Coagulopathy defined as INR,APTT,and PT beyond the upper limit of normal range
  • Known pregnancy, or positive pregnancy test, or breastfeeding
  • Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial
  • A high likelihood that the patient will not adhere to the study treatment and follow up regimen
  • Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • First Hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT03484936 · SERIC-sICH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗