脑出血手术。

B. Gregson, A. Mendelow, H. Fernandes, A. Pearson, M. Siddique
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引用次数: 11

摘要

这项研究为自发性脑出血手术的大规模随机试验的必要性提供了更多的证据,正如之前所显示的那样。我们希望通知你方读者这一试验的进展情况。STICH(脑出血外科试验)由英国医学研究委员会资助,但向任何国家的中心开放,我们将邀请感兴趣的中心与我们联系。STICH是一项多中心、实用的随机试验,旨在招募1000名患者。这项试验是由纽卡斯尔大学(英国)的一个团队管理的。迄今为止,我们在英国、德国、瑞典、西班牙、匈牙利、波兰、捷克、意大利、比利时、希腊、乌克兰、俄罗斯、南非、香港和美国拥有68家中心。在确定患者身份、征得患者同意并填写随机化表格后,通过电话给牛津大学(英国)随机化服务中心进行随机化。2周后(或在死亡或出院时)填写另一份表格,记录患者此时的状态和任何手术或不良事件的详细信息。纽卡斯尔的研究小组在6个月后进行了随访,并向每位患者发送了一份问卷。到目前为止,我们共招募了273例患者,其中130例患者获得了6个月的完整随访数据。该试验正在按照MRC临床试验良好临床实践指南进行,数据将在招募最终患者后由治疗组进行分析。我们的研究将允许我们调查手术时间是否对结果有影响。尽管30%的患者在12小时内被随机化,但在发作后72小时内进行随机化的时间最长。随机分配到早期手术的患者在24小时内接受治疗外科医生首选的手术方法,并接受最好的医疗护理。随机分配到初始保守治疗的患者接受最好的医疗护理,包括在适当的情况下从神经外科早期转移。如果病人的病情发生变化,手术是合适的,可以进行晚期手术。只有当神经外科医生不确定是否需要手术时,患者才能被纳入研究。为了尽快达到1000个样本的目标,我们欢迎其他中心的参与。任何想参加这项研究的人都可以给我们发电子邮件至stich@ncl.ac.uk。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Surgery for intracerebral hemorrhage.
This study provides yet more evidence of the need for a large randomized trial of surgery for spontaneous intracerebral hemorrhage, as has been shown previously. 2–8 We wish to inform your readers of the progress of such a trial. The STICH (Surgical Trial in Intracerebral Haemorrhage) has been funded by the Medical Research Council (UK) but is open to centers from any country, and we would invite interested centers to contact us. STICH is a multicenter, pragmatic, randomized trial aiming to recruit 1000 patients. The trial is managed by a team at Newcastle University (UK). To date, we have 68 centers from the United Kingdom, Germany, Sweden, Spain, Hungary, Poland, Czech Republic, Italy, Belgium, Greece, Ukraine, Russia, South Africa, Hong Kong and the United States. Randomization is performed by telephoning the Randomisation Service at Oxford University (UK) after identifying a patient, gaining consent, and completing a randomization form. An additional form is completed 2 weeks later (or at death or discharge if earlier) to record patient status at this point and details of any surgery or adverse events. Follow-up at 6 months is obtained by the team in Newcastle, who send a questionnaire to each patient for completion. So far we have recruited 273 patients to the study, and complete 6-month follow-up data has been achieved for 130 patients. The trial is being carried out following the MRC Guidelines for Good Clinical Practice in Clinical Trials, and the data will be analyzed by treatment group after the recruitment of the final patient. Our study will permit us to investigate whether time to surgery has an effect on outcome. Time to randomization is up to 72 hours after ictus, although 30% of patients are randomized within 12 hours. Patients randomized to early surgery receive the treating surgeon’s preferred method of surgery, as soon as possible within 24 hours, and best medical care. Patients randomized to initial conservative treatment receive best medical care, including early transfer from the neurosurgery department if appropriate. Late surgery may be performed if the patient’s condition changes and surgery becomes appropriate. Patients can be included in the study only if the neurosurgeon is uncertain about the need for surgery. To achieve our target sample of 1000 as soon as possible, we would welcome participation of additional centers. Anyone who wishes to join the study should email us at stich@ncl.ac.uk.
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