MICA: The third, Intensive care bundle with blood pressure reduction in acute cerebral haemorrhage (INTERACT3) trial
Medical Research Council
George Institute for Global Health
INTERACT3 is an international, multicentre, stepped-wedge, cluster randomised, blinded outcome assessed, clinical trial (Phase III-IV). The objective is to determine the effectiveness of a goal-directed care bundle of active management involving intensive BP lowering, glycaemic control, early treatment of pyrexia, and reversal of anticoagulation, against a practice of usual care, on the standard clinical outcome of functional recovery in patients with acute spontaneous ICH. The primary outcome measure is an ordinal shift analysis of all 7-levels (scores) on the modified Rankin scale (mRS, categories 0 to 6: 0=no symptoms, 1=no significant disability, 2=slight disability, 3= moderate disability, 4=moderate severe disability, 5=severe disability, 6=death) at 6 months. Secondary outcomes include early functional neurological recovery (according to a shift analysis of scores on the National Institutes of Health stroke scale [NIHSS] at 7 days), health-related quality of life (HRQoL) using the EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D) at 6 months, duration of hospitalisation, and residence. This research will be conducted through a global network of investigators from nine LMICs. The stepped-wedge cluster randomised design has been chosen to avoid contamination, facilitate hospital-wide implementation, and maximise adherence as the complex intervention under investigation becomes usual standard of care. A consecutive recruiting approach is involved to minimise bias in patient selection into the study. A mixed consent process is proposed according to local/national rules and regulations. Besides an individual standard consent for the data collection and follow-up, a cluster guardian consent is required for patients to receive the randomised care bundle to be implemented for acute ICH patients across multiple wards as a systems of care approach.
4.1 Discovery and preclinical testing of markers and technologies / Research Grant