A Space-expanding Shield in Decompressive Hemicraniectomy for 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: DCE + SPACE SHIELD, DCE + CP.
- Кому может быть актуально
- Состояния в реестре: Stroke. Базовые параметры: 18 лет — 70 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
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial
Обзор
Instead of the standard decompressive hemicraniectomy with subsequent cranioplasty a single surgery with the implantation of an individually molded space-expanding shield is investigated in for patients with increased intracranial pressure due to a malignant stroke.
Подробное описание
Background:
A malignant cerebral infarction causes edema resulting in a threatening increase of the intracranial pressure (ICP). Standard of care is a surgical removal of a part of the skull above the ischemic brain, the so-called decompressive hemicraniectomy (DCE). DCE allows the brain to swell, after detumescence of the brain parenchyma (usually several months later) the patients undergo a second surgery with implantation of either their own preserved bone flap or a bone flap substitute (a procedure referred to as cranioplasty (CP)).
Objective:
Despite its proven life-saving benefits, the strategy of DCE followed by CP carries several risks, among others
* Exposure of the brain parenchyma * Various neurological deficits subsumed under the syndrome of the trephined * Bone resorption: As shown in a previous prospective cohort study the above-mentioned risks may be prevented using an intraoperatively molded space-expanding protective shield, which is implanted and fixed directly after having performed (a so far customary) DCE. This shield allows the brain to swell while still providing protection.
SPACE SHIELD investigates whether the single-stage strategy of implanting a space-expanding shield represents a viable alternative to the standard DCE followed by CP."
Methods:
The inclusion of patients is planned to take place from January 2025 to December 2029. The study duration for the individual patients is 6 months. While the intervention group will be treated with the above-described space-expanding shield the control group will be treated with the customary DCE and following CP. The CP will be performed either with the original bone flap stored in customary manner or with a PMME bone flap. Examinations of the patients are planned after 1 - 7 days, 6 weeks, 3 months and 6 months after the initial surgery.
Вмешательства
- Процедура DCE + SPACE SHIELD
Patients receive a DCE with implantation of a space-expanding shield. - Процедура DCE + CP
Patients in the control group receive a DCE similar to the intervention group, but without implantation of a space-expanding shield. Cranioplasty (CP) is performed after \~ 90 days in the customary manner.
Первичные конечные точки
- modified Ranking Scale (mRS) score at 6 months [Срок оценки: 6 months after surgery]
Вторичные конечные точки (8)
- Number of further surgical interventions for ICP control [Срок оценки: 6 months after surgery]
- Occurrence of Hydrocephalus [Срок оценки: 6 months after surgery]
- Number of Infections [Срок оценки: 6 months after surgery]
- Wound healing difficulties [Срок оценки: 6 months after surgery]
- Syndrome of the trephined [Срок оценки: 6 months after surgery]
- Overall survival at 6 months [Срок оценки: 6 months after surgery]
- Cosmetic satisfaction at 6 months [Срок оценки: 6 months after surgery]
- Quality of life score: EQ-5D-5L [Срок оценки: 6 months after surgery]
Критерии участия
Критерии включения
- Patients with malignant infarction of the middle cerebral artery identified by MRI including diffusion-weighted imaging or CT including perfusion imaging - fulfilling the European guidelines for decompressive hemicraniectomy (DCE) for stroke
- ≥ 18 and < 70 years of age
- Availability of consent from a next of kin and from the patient represented by an independent physician
Критерии исключения
- Hyperacute need for DCE due to rapid neurological decline
- Contraindications to the use of polymethyl-methacrylate (PMMA), e.g., known hypersensitivity, allergy
- Known gentamicin allergy
- Pregnancy and active breast-feeding
- Patients with a former history of DCE and/or CP
- Active pulmonary or cranial infection
- Known coagulopathy independent of medication
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Швейцария · 6 центров
- Kantonsspital Aarau — Aarau
- Universitätsspital Basel — Basel
- Inselspital Bern, Department of Neurosurgery — Bern
- Luzerner Kantonsspital — Lucerne
- Ente Ospedaliero Cantonale — Lugano
- Kantonsspital St.Gallen — Sankt Gallen
Идентификаторы
NCT: NCT06638385 · SPACE SHIELD