Swiss trial of decompressive craniectomy versus best medical treatment of spontaneous supratentorial intracerebral haemorrhage (SWITCH): an international, multicentre, randomised-controlled, two-arm, assessor-blinded trial.

IF 5.8 3区 医学 Q1 CLINICAL NEUROLOGY European Stroke Journal Pub Date : 2024-09-01 Epub Date: 2024-02-12 DOI:10.1177/23969873241231047
Urs Fischer, Christian Fung, Seraina Beyeler, Lukas Bütikofer, Werner Z'Graggen, Florian Ringel, Jan Gralla, Karl Schaller, Nikolaus Plesnila, Daniel Strbian, Marcel Arnold, Werner Hacke, Peter Jüni, Alexander David Mendelow, Christian Stapf, Rustam Al-Shahi Salman, Jenny Bressan, Stefanie Lerch, Claudio L A Bassetti, Heinrich P Mattle, Andreas Raabe, Jürgen Beck
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Abstract

Rationale: Decompressive craniectomy (DC) is beneficial in people with malignant middle cerebral artery infarction. Whether DC improves outcome in spontaneous intracerebral haemorrhage (ICH) is unknown.

Aim: To determine whether DC without haematoma evacuation plus best medical treatment (BMT) in people with ICH decreases the risk of death or dependence at 6 months compared to BMT alone.

Methods and design: SWITCH is an international, multicentre, randomised (1:1), two-arm, open-label, assessor-blinded trial. Key inclusion criteria are age ⩽75 years, stroke due to basal ganglia or thalamic ICH that may extend into cerebral lobes, ventricles or subarachnoid space, Glasgow coma scale of 8-13, NIHSS score of 10-30 and ICH volume of 30-100 mL. Randomisation must be performed <66 h after onset and DC <6 h after randomisation. Both groups will receive BMT. Participants randomised to the treatment group will receive DC of at least 12 cm in diameter according to institutional standards.

Sample size: A sample of 300 participants randomised 1:1 to DC plus BMT versus BMT alone provides over 85% power at a two-sided alpha-level of 0.05 to detect a relative risk reduction of 33% using a chi-squared test.

Outcomes: The primary outcome is the composite of death or dependence, defined as modified Rankin scale score 5-6 at 6 months. Secondary outcomes include death, functional status, quality of life and complications at 180 days and 12 months.

Discussion: SWITCH will inform physicians about the outcomes of DC plus BMT in people with spontaneous deep ICH, compared to BMT alone.

Trial registration: ClinicalTrials.gov Identifier: NCT02258919.

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瑞士自发性幕上脑室内出血减压开颅术与最佳药物治疗对比试验(SWITCH):一项国际性、多中心、随机对照、双臂、评估者盲法试验。
理由:减压开颅术(DC)对恶性大脑中动脉梗死患者有益。目的:确定对 ICH 患者进行不清除血肿的减压开颅术加最佳治疗(BMT)与单纯 BMT 相比,是否会降低患者 6 个月后死亡或依赖的风险:SWITCH是一项国际多中心、随机(1:1)、双臂、开放标签、评估者盲法试验。主要纳入标准为:年龄⩽75 岁,因基底节或丘脑 ICH 引起的中风,且 ICH 可能扩展到脑叶、脑室或蛛网膜下腔,格拉斯哥昏迷量表评分 8-13 分,NIHSS 评分 10-30 分,ICH 容量 30-100 毫升。必须进行随机抽样:300名参与者按1:1的比例随机接受DC加BMT治疗与单纯BMT治疗,在双侧α水平为0.05的情况下,使用卡方检验可检测到超过85%的力量,以检测到33%的相对风险降低:主要结果是死亡或依赖的复合结果,定义为 6 个月时修改后的 Rankin 量表评分 5-6 分。次要结果包括 180 天和 12 个月时的死亡、功能状态、生活质量和并发症:SWITCH将使医生了解自发性深部ICH患者接受DC加BMT治疗与单纯BMT治疗的结果:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT02258919。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
7.50
自引率
6.60%
发文量
102
期刊介绍: Launched in 2016 the European Stroke Journal (ESJ) is the official journal of the European Stroke Organisation (ESO), a professional non-profit organization with over 1,400 individual members, and affiliations to numerous related national and international societies. ESJ covers clinical stroke research from all fields, including clinical trials, epidemiology, primary and secondary prevention, diagnosis, acute and post-acute management, guidelines, translation of experimental findings into clinical practice, rehabilitation, organisation of stroke care, and societal impact. It is open to authors from all relevant medical and health professions. Article types include review articles, original research, protocols, guidelines, editorials and letters to the Editor. Through ESJ, authors and researchers have gained a new platform for the rapid and professional publication of peer reviewed scientific material of the highest standards; publication in ESJ is highly competitive. The journal and its editorial team has developed excellent cooperation with sister organisations such as the World Stroke Organisation and the International Journal of Stroke, and the American Heart Organization/American Stroke Association and the journal Stroke. ESJ is fully peer-reviewed and is a member of the Committee on Publication Ethics (COPE). Issues are published 4 times a year (March, June, September and December) and articles are published OnlineFirst prior to issue publication.
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