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。ICH的发病率在低收入和中等收入国家（LMIC）中较高，特别是因为高血压的患病率较高。脑出血预后严重，至少三分之二的患者死亡或致残。鉴于ICH的复杂性和严重性，需要可靠的证据来指导医疗服务和政策制定。然而，在这种情况下，在确立明确的证据证明特定管理策略的益处方面进展缓慢。然而，有良好的临床前和观察数据表明，可以通过早期严格管理几个关键生理参数来改善结局。此外，对中风的医院管理数据的审计表明，许多循证建议的依从性普遍较差。目的和目标INTERACT 3（第三次，在急性脑出血试验中降低血压的综合护理组合）是一项由研究者发起并进行的国际性、多中心、随机分组临床试验。本研究旨在确定早期重症监护包（降低血压、血糖控制、治疗发热和逆转抗凝）的有效性。总体目标包括：（i）解决急性ICH最适当医疗管理的持续不确定性;（ii）了解LMIC中ICH的常规护理模式，特别是与使用当地方案、途径和实施当前国家和国际指南有关的模式;（iii）探索实施和坚持复杂干预的障碍;以及（iv）探讨如何最好地将循证医学建议纳入中低收入国家的常规医疗实践中。潜在应用和益处本研究将为ICH的急性管理提供可靠证据，并帮助卫生部门的专业人员、服务开发人员和政策制定者做出决策。关于ICH管理和结局的可靠数据可以提高护理质量并降低LMIC中ICH的高负担。卒中患者（尤其是ICH患者）护理的临床实践以及对指南的遵守，可以通过参与在LMIC多家医院进行的高质量临床试验来改善结局。此外，该结果可能具有广泛的普遍受益，因为干预措施的评价将在广泛的患者中进行，包括那些严重ICH和/或接受手术的患者，这些患者迄今为止已被排除在常规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.