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

The context of the research Acute 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 objectives INTERACT3 (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 benefits This 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.