An investigator initiated international, multicentre, stepped wedge cluster randomised study of a care bundle of physiological control strategies in acute intracerebral haemorrhage patients in comparison to usual care

INTERVENTION: Study Settings include the following: • National Hospital of Sri Lanka • Colombo South Teaching Hospital • Kurunegala Teaching Hospital • Karapitiya Teaching Hospital • Jaffna Teaching Hospital • Kandy National Hospital Randomization method: The unit of randomisation is the hospital site; randomly assigned by a statistician. Participating sites will be stratified according to country and size of site. When the site is ready, they will be notified of the randomised group within 2 weeks of an agreed date of commencing the study. Intervention: All patients will receive continuous noninvasive cardiac monitoring, including ECG, oxygen saturation, heart rate and arterial blood pressure. Routine laboratory tests will be performed on admission and at least once during the following 7 days; in the case of significant abnormalities, they were taken daily. Goal‐directed care bundle of active management group will include; 1. Early intensive BP lowering. The aim is to achieve a systolic BP level <140mmHg within 1 hour of treatment and to maintain this BP level for the next 7 days or hospital discharge should this occur earlier. Intravenous BP lowering is to commence as soon as possible upon admission. If systolic blood pressure (SBP) ? 140 mmHg and heart rate (HR) > 55 bpm, repeat labetalol 10 mg bolus in 5 minutes. labetalol 20 mg IV push q 5 mins until target SBP reached (< 140mmHg) or HR <55 bpm; increase to 40 mg bolus if required. Maximum labetalol dose: 300 mg / 24 hours 2. Intensive glucose control. The aim is to achieve a target blood glucose level of 6.1‐7.8 mmol/l for non‐diabetic patients and 7.8‐10.0mmol/l for diabetic patients and to maintain this blood glucose level for the next 7 days or hospital discharge CONDITION: Acute spontaneous intracerebral haemorrhage PRIMARY OUTCOME: Functional recovery according to an ordinal shift analysis of the full range of scores on the modified Rankin scale (mRS) scores at 6 months [6 Months ]; SECONDARY OUTCOME: Functional recovery according to a shift analysis of scores on the National Institutes of Health Stroke Scale (NIHSS) at 7 days. The following at 6‐months: poor outcome defined by mRS scores of 3‐6; separately on death and disability (mRS 3‐5); health‐related quality of life (HRQoL) using the EuroQoL Group 5‐Dimension self‐report questionnaire (EQ‐5D); duration of hospitalisation; and residence. [6 months]; INCLUSION CRITERIA: • Age >= 18 (both male and female) • Acute stroke syndrome that is due to presumed spontaneous ICH, confirmed by clinical history and a CT scan within 6 hours of stroke onset without/without contrast, and if an CT angiogram is also undertaken as part of routine care. • Presentation to hospital within 6 hours of stroke onset