A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- modified Ranking Scale (mRS) score at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
modified Ranking Scale (mRS) score at 6 months
时间窗: 6 months after surgery
The primary outcome will be assessed by a blinded, independent, local study nurse. The sole task of this study nurse will be to assess the mRS based on a short interview with the patient.
次要结局
- Number of further surgical interventions for ICP control(6 months after surgery)
- Occurrence of Hydrocephalus(6 months after surgery)
- Number of Infections(6 months after surgery)
- Wound healing difficulties(6 months after surgery)
- Syndrome of the trephined(6 months after surgery)
- Overall survival at 6 months(6 months after surgery)
- Cosmetic satisfaction at 6 months(6 months after surgery)
- Quality of life score: EQ-5D-5L(6 months after surgery)