The AGAINST Protocol: Augmentative Craniotomy in Stroke: a Prospective, Randomized, Controlled, Multicentre, Comparative Trial on Decompressive Craniectomy and Augmentative Craniotomy in Malignant Middle Cerebral Infarction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Changes in functional and neurological status
研究概览
简要总结
Malignant Middle Cerebral Artery (MCA) infarction is a term used for the severe clinical and neurological hemispheric syndrome caused by ischemic occlusion of the proximal tract of MCA and it is observed in near the 10% of all ischemic strokes.In order to prevent the severe consequences caused by malignant MCA infarction, decompressive hemicraniectomy has been proposed as early intervention against the expected clinical worsening due to endocranial hypertension and several trials demonstrated how it positively affects the mortality and morbidity rates compared to conservative management. However, patients undergoing decompressive hemicraniectomy generally encounter other kinds of complications, related to the consequences of the surgical procedure. With the intent of reducing these complications, alternative decompression techniques have been proposed, such as hinge or floating craniectomy or augmentative craniotomy, in which the bony operculum is left in place. These alternative methods of cranial decompression have been shown to have similar efficacy to standard craniectomy, but comparative trials have never been conducted.In the present protocol, the investigators present a study design that compares the standard decompressive hemicraniectomy to a novel technique of augmentative craniotomy. The rationale of the study is to maintain the important advantages related to brain decompression in malignant MCA infarction while avoiding the complications related to the surgical procedure of hemicraniectomy.
详细描述
AGAINST is a prospective, randomised, controlled, open, multicentre, two-armed, comparative trial. Patients are randomised 1:1 to either treatment with hemicraniectomy or with augmentative craniotomy. Complete blinding is virtually impossible both for treating physicians and patients due to visible aesthetic differences between the two groups. All participating centers dispose of 24/h per day neurosurgical facilities. Ethical boards of each participating center approved the present trial protocol. The enrollment will stop as soon as statistical difference between two groups would be reached. The study design of the present clinical trial protocol adhere to the SPIRIT and CONSORT guidelines.
Treatment protocol
Patients who pass the screening of inclusion and criteria will be considered suitable for the enrollment in the study. After medical evaluation and neuroimaging, written informed consent will be obtain before enrolling the patient in the study. Then, randomization is performed online (trough http//:randomizer.at) and, if the online randomization fails, patients will be randomized through a sealed envelope system managed by a 24-h/7-day phone service. Consequentially, the patient is assigned to one of the following groups of treatment: Group I, augmentative craniotomy; Group 2, decompressive hemicraniectomy. Surgical treatment will be performed not later than 48 hours after symptoms onset and not later than 6 hours after randomization.
The allocation ratio between the two groups is 1:1.
Augmentative craniotomy
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only MCA ischemic strokes have been considered, with no distinctions between the execution of precedent treatment (thrombolysis and/or thrombectomy)
- •Patients' age <75 years old.
- •NIHSS >1a, >14 for right sided lesions, >15 for left sided lesions
- •Symptoms onset <48 hours before surgery or conservative treatment
- •Neuroradiological findings: unilateral ischemic infarction of at least 1/3 of MCA territory is involved. Ischemic core volume>140ml. Hypodensity on head CT within the first 6 hours of stroke onset involving one-third or more of the MCA territory, early midline shift, and magnetic resonance imaging diffusion-weighted imaging volume within 6 hours ≥80 mL.
- •informed consent by the patient him/herself, his/her legal representative, adjudication by a legally competent judge, or by an independent physician
排除标准
- •- presence of concomitant or associated brain lesion
- •presence of concomitant comorbidities or other clear contraindications for treatment
- •participation in any other interventional trial
结局指标
主要结局
Changes in functional and neurological status
时间窗: From recruitment to 12 months
Modified Rankin score(mRS) ranges from 0 to 6. Lower points represent better outcomes
Changes in quality of life
时间窗: From recruitment to 12 months
36-item short form survey (SF-36) ranges from 0 to 100. Lower points represent worse outcomes
次要结局
- surgical complications(From recruitment to 12 months)
研究者
Luigi Valentino Berra
Principal investigator, MD, Consultant in Neurosurgery
University of Roma La Sapienza