Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
BMJ Open. 2019 Jul 16;9(7):e030121. doi: 10.1136/bmjopen-2019-030121.
Conflicting results from multiple randomised trials indicate that the methods and effects of blood pressure (BP) reduction after acute intracerebral haemorrhage (ICH) are complex. The Blood pressure in Acute Stroke Collaboration is an international collaboration, which aims to determine the optimal management of BP after acute stroke including ICH.
A systematic review will be undertaken according to the Preferred Reporting Items for Systematic review and Meta-Analysis of Individual Participant Data (IPD) guideline. A search of Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception will be conducted to identify randomised controlled trials of BP management in adults with acute spontaneous (non-traumatic) ICH enrolled within the first 7 days of symptom onset. Authors of studies that meet the inclusion criteria will be invited to share their IPD. The primary outcome will be functional outcome according to the modified Rankin Scale. Safety outcomes will be early neurological deterioration, symptomatic hypotension and serious adverse events. Secondary outcomes will include death and neuroradiological and haemodynamic variables. Meta-analyses of pooled IPD using the intention-to-treat dataset of included trials, including subgroup analyses to assess modification of the effects of BP lowering by time to treatment, treatment strategy and patient's demographic, clinical and prestroke neuroradiological characteristics.
No new patient data will be collected nor is there any deviation from the original purposes of each study where ethical approvals were granted; therefore, further ethical approval is not required. Results will be reported in international peer-reviewed journals.
CRD42019141136.
多项随机试验的结果相互矛盾，表明急性脑出血（ICH）后血压（BP）降低的方法和效果较为复杂。急性卒中血压协作研究是一个国际合作项目，旨在确定急性卒中（包括 ICH）后 BP 管理的最佳方法。
将根据系统评价和个体参与者数据（IPD）荟萃分析的首选报告项目（IPD）指南进行系统评价。将从 Cochrane 对照试验中心注册库、EMBASE 和 MEDLINE 检索从发病开始到 7 天内纳入的急性自发性（非创伤性）ICH 成人 BP 管理的随机对照试验。将邀请符合纳入标准的研究作者共享其 IPD。主要结局将是根据改良Rankin 量表的功能结局。安全性结局将是早期神经功能恶化、症状性低血压和严重不良事件。次要结局将包括死亡以及神经影像学和血液动力学变量。将使用纳入试验的意向治疗数据集对汇总的 IPD 进行荟萃分析，包括亚组分析，以评估治疗时间、治疗策略和患者的人口统计学、临床和卒中前神经影像学特征对降压效果的影响的改变。
不会收集新的患者数据，也不会偏离每个获得伦理批准的研究的原始目的；因此，不需要进一步的伦理批准。结果将在国际同行评议的期刊上报告。
PROSPERO 注册号：CRD42019141136。
