MICA: The third, Intensive care bundle with blood pressure reduction in acute cerebral haemorrhage (INTERACT3) trial

研究背景急性脑出血(ICH)是最严重的中风类型，每年影响世界上数百万人。在低收入和中等收入国家，脑出血的发病率很高，特别是因为高血压患病率很高。ICH预后严重，至少三分之二的患者要么死亡，要么残废。鉴于非物质文化遗产的复杂和严重性质，需要可靠的证据来指导卫生保健的提供和政策制定。然而，在已建立的明确证据表明在这种情况下具体的管理策略是有益的方面，进展缓慢。然而，有良好的临床前和观察数据表明，通过早期严格管理几个关键的生理参数可以改善结果。此外，对中风的医院管理数据的审计表明，许多循证建议普遍得不到遵守。目的和目的INTERACT3(第三个重症监护捆绑降压急性脑出血试验)是一项由研究者发起并进行的国际性、多中心、随机成组临床试验。本研究旨在确定早期重症监护捆绑治疗(降压、血糖控制、治疗发热和逆转抗凝)的有效性。总体目标包括：(1)解决急性脑出血最适当的医疗管理方面持续存在的不确定因素；(2)了解LMIC对脑出血的常规护理模式，特别是在使用当地方案、途径和执行现行国家和国际指南方面；(3)探索实施和遵守复杂干预措施的障碍；以及(Iv)探索如何最好地采用循证建议并将其整合到低收入国家的常规保健实践中。潜在的应用和益处本研究将为脑出血的急性管理提供可靠的证据，并帮助卫生部门的专业人员、服务开发商和政策制定者做出决策。有关ICH管理和预后的可靠数据可以提高护理质量，减轻LMIC中ICH的沉重负担。护理中风患者，特别是脑出血患者的临床实践，以及遵守指南，可以通过参与在LMICs的多家医院进行的高质量临床试验来改善结果。此外，这一结果可能具有广泛的普适性，因为对干预措施的评估将在广泛的患者中进行，包括那些严重的脑出血和/或接受手术的患者，这些患者迄今已被排除在常规的个体患者随机试验之外。

The context of the researchAcute intracerebral haemorrhage (ICH) is the most severe type of stroke, which affects millions people in the world each year. The incidence of ICH is high in low- and middle- income countries (LMICs), particularly because prevalence of hypertension is high. ICH has a grave prognosis, with at least two thirds of the patients either dying or left with disability. Given the complex and serious nature of ICH, reliable evidence is required to guide health care delivery and policy making. However, the progress has been slow in established clear evidence of benefit for specific management strategies in this condition. However, there is good pre-clinical and observational data indicating that outcomes can be improved through early strict management of several key physiological parameters. Moreover, audits of hospital administrative data for stroke indicate there is widespread poor adherence to many evidence-based recommendations. Aims and objectivesINTERACT3 (The third, INTEnsive care bundle with blood pressure Reduction in Acute Cerebral haemorrhage Trial) is an investigator initiated and conducted, international, multicentre, randomised cluster clinical trial. The study aims to determine the effectiveness of early intensive care bundle (BP lowering, glycaemic control, treatment of pyrexia, and reversal of anticoagulation). The overall objectives include: (i) to solve persistent uncertainties of the most appropriate medical management of acute ICH; (ii) to understand the patterns of usual care for ICH in LMIC, in particular in relation to the use of local protocols, pathways and implementation of current national and international guidelines; (iii) to explore the barriers to implementation and adherence to a complex intervention; and (iv) to explore how best to adopt and integrate evidence-based recommendations into routine health care practice in LMICs.Potential applications and benefitsThis study will provide reliable evidence on the acute management of ICH and assist decision makings by professionals, service developers, and policy makers in health sectors. Reliable data on ICH management and outcomes could improve quality of care and reduce the high burden of ICH in LMIC. Clinical practice in the care of stroke patients, particularly those with ICH, and adherence to guidelines, could improve outcomes through participation in a high quality clinical trial conducted across multiple hospitals in LMICs. Moreover, the result could have a widely generalizable benefit, since evaluation of the intervention will be in a broad range of patients, including those severe ICH and/or who undergo surgery, who have been excluded from conventional individual patient randomised trials to date.