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Идёт набор NCT05327933

Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization

Без фазы С лечением Hematoma, Subdural, Chronic

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: Surgery plus endovascular MMA embolization, Surgery alone.
Кому может быть актуально
Состояния в реестре: Hematoma, Subdural, Chronic. 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
Германия
Следующий шаг
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Официальное название

Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)

Обзор

Patients with a chronic subdural hematoma (cSDH), that is, a blood accumulation between two meninges developing over a long period of time, often have recurrent bleedings after an initial operation. The study aims to show that additional surgery reduces the risk of recurrent bleeding. The additional procedure aims to block small blood vessels in the skull with tiny plastic particles. The small blood vessels are embolized using X-rays and a contrast medium and a fine tube that is inserted into the diseased vessels of the head via the groin. Patients of full age who have undergone burr hole trepanation as a first operation, i.e. a blood drain through a hole in the cranial cavity, can participate in the study. Participating patients are randomly assigned to a control group with treatment according to clinical routine or a treatment group with an additional occlusion of the blood vessels in the skull. In addition, patients can consent to a genetic test to determine the relationship between a coagulation factor and the risk of recurrence of the hematoma. In order to record the test results, check-up examinations are carried out after one and three months.

Вмешательства

  • Процедура Surgery plus endovascular MMA embolization
    A micro catheter is inserted transfemorally into the branches of the middle meningeal artery (MMA) in a minimally invasive manner and the periphery is occluded using polyvinyl alcohol (PVA) particles to prevent future bleeding. If the desired catheter position cannot be achieved due to the anatomical conditions, a more proximal closure of the MMA using Onyx® or micro-electric coils is performed. Embolization of the MMA by PVA particles with sizes between 40-300 µm is preferred over embolization
  • Процедура Surgery alone
    Evacuation of cSDH

Первичные конечные точки

  • cSDH recurrence rates after surgery [Срок оценки: Within three months of follow-up]
Вторичные конечные точки (3)
  • Impairment due to neurological deficits assessed by the modified Rankin Scale [Срок оценки: Evaluated at three months after baseline]
  • Number of recurrence-associated complications [Срок оценки: Within three months of follow-up]
  • Number of complications associated with interventional therapy [Срок оценки: Within three months of follow-up]

Критерии участия

Критерии включения

  • Patients who have undergone surgery by means of one or more burr hole trepanations during the first manifestation of a cSDH (unihemispherical or bihemispherical) detected by computed tomography or magnetic resonance tomography
  • Age ≥18 years
  • Sufficient compliance and ability to consent
  • Patient's informed consent for surgical as well as endovascular interventional procedure and participation in the study

Критерии исключения

  • Conservatively treated cSDH
  • Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma
  • Surgical technique: craniotomy, craniectomy, bilateral burr hole trepanation
  • Angiography cannot be performed within 72 hours after surgery
  • Age <18 years
  • Supervisory relationship
  • Pregnancy
  • Lack of informed consent
  • Lack of compliance
  • Homozygous factor XIII deficiency with residual activity <10%

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
Профилактика

Центры проведения

Германия · 1 центр
  • Unfallkrankenhaus Berlin — Berlin

Публикации

  • Hoenning A, Lemcke J, Rot S, Stengel D, Hoppe B, Zappel K, Schuss P, Mutze S, Goelz L. Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial. Trials. 2022 Aug 22;23(1):703. doi: 10.1186/s13063-022-06506-3. PMID 35996195

Идентификаторы

NCT: NCT05327933 · MMA_SP · DRKS00020465

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗