脑出血血小板输注（PATCH）试验的统计分析计划：一项多中心随机对照试验
Statistical analysis plan for the PlAtelet Transfusion in Cerebral Haemorrhage (PATCH) trial: a multicentre randomised controlled trial.
作者信息
Baharoglu M Irem, Al-Shahi Salman Rustam, Cordonnier Charlotte, de Haan Rob J, Roos Yvo B W E M
机构信息
Department of Neurology, Academic Medical Centre, H2-222, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, Royal Infirmary of Edinburgh, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
出版信息
Trials. 2016 Aug 2;17:379. doi: 10.1186/s13063-016-1478-y.
BACKGROUND
Use of antiplatelet therapy shortly before stroke due to spontaneous primary intracerebral haemorrhage (ICH) is associated with higher case fatality in comparison to ICH without prior antithrombotic drug use. The PlAtelet Transfusion in Cerebral Haemorrhage (PATCH) trial aimed to assess the effect of platelet transfusion in patients presenting with ICH while using antiplatelet therapy. The main hypothesis of PATCH was that platelet transfusion would reduce death or dependence by reducing ICH growth.
METHODS/DESIGN: PATCH was a multicentre prospective, randomised, open, blinded endpoint (PROBE) parallel group trial, conducted at 60 hospitals in The Netherlands, Scotland and France. Forty-one sites enrolled 190 patients with spontaneous supratentorial ICH aged ≥18 years, who had used antiplatelet therapy for ≥7 days preceding ICH, if Glasgow Coma Scale was ≥8. Participants were randomised (1:1, with a secure web-based system using permuted blocks, stratified by study centre and type of antiplatelet therapy pre-ICH) to receive either platelet transfusion within 6 hours of symptom onset and 90 minutes of diagnostic brain imaging, or standard care without platelet transfusion. The primary outcome was modified Rankin Scale (mRS) score assessed blind to treatment allocation at 3 months after ICH. Planned secondary outcomes included ICH growth on brain imaging performed approximately 24 hours after randomisation, survival at 3 months, disability at 3 months scored using the Amsterdam Medical Centre linear disability score, heterogeneity of treatment effect on mRS and ICH growth according to presence of the computed tomography angiography spot sign, causes of poor outcome, and cost-effectiveness. Safety outcomes were transfusion reactions, thromboembolic complications, and serious adverse events occurring during hospitalisation. This statistical analysis plan was written without knowledge of the unblinded data.
TRIAL REGISTRATION
The trial was registered with the Netherlands Trial Register on 29 April 2008 ( NTR1303 ).
背景
与未使用过抗血栓药物的自发性原发性脑出血（ICH）相比，在ICH发生前不久使用抗血小板治疗与更高的病死率相关。脑出血血小板输注（PATCH）试验旨在评估在使用抗血小板治疗的ICH患者中输注血小板的效果。PATCH的主要假设是血小板输注将通过减少ICH的扩大来降低死亡或依赖。
方法/设计：PATCH是一项多中心前瞻性、随机、开放、盲终点（PROBE）平行组试验，在荷兰、苏格兰和法国的60家医院进行。41个研究点纳入了190例年龄≥18岁的自发性幕上ICH患者，这些患者在ICH发生前使用抗血小板治疗≥7天，格拉斯哥昏迷量表评分≥8分。参与者被随机分组（1:1，使用基于网络的安全系统，采用置换块法，按研究中心和ICH前抗血小板治疗类型分层），在症状发作后6小时内且诊断性脑成像后90分钟内接受血小板输注，或接受不进行血小板输注的标准治疗。主要结局是在ICH发生后3个月时，对治疗分配情况不知情的情况下评估的改良Rankin量表（mRS）评分。计划的次要结局包括随机分组后约24小时进行的脑成像上的ICH扩大情况、3个月时的生存率、使用阿姆斯特丹医学中心线性残疾评分在3个月时评估的残疾情况、根据计算机断层血管造影斑点征的存在情况对mRS和ICH扩大的治疗效果异质性、不良结局的原因以及成本效益。安全性结局是输血反应、血栓栓塞并发症以及住院期间发生的严重不良事件。本统计分析计划是在不知道未盲法数据的情况下编写的。
试验注册
该试验于2008年4月29日在荷兰试验注册中心注册（NTR1303）。
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