Procedures
death, Stroke, intracerebral haemorrhage, neurological impairment, diabetes
STROKE, INTRACEREBRAL HAEMORRHAGE, RECRUITMENT, BRAIN, DIABETES
Before hospitals began screening and recruiting patients, key staff from participating sites were trained in the study procedures at regional and individual hospital meetings. In the 7–10 days after sites had completed the control usual care period, these staff received online training and remote communication on the intensive care bundle protocol to be applied as a system of care for eligible patients. The components of the care bundle included: early intensive blood pressure management with the goal of achieving a target systolic blood pressure of less than 140 mm Hg within 1 h of the initiation of treatment, with a systolic blood pressure of 130 mm Hg being the threshold for the cessation of treatment; intensive control of elevated blood glucose with the goal of achieving a glucose target of 6·1–7·8 mmol/L for patients without diabetes and 7·8–10·0 mmol/L for patients with diabetes as soon as possible after the initiation of treatment, as recommended in guidelines for minimal risk of harm from hypoglycaemia;To ensure continuous recruitment, each participating site was required to register all patients with a diagnosis of intracerebral haemorrhage into screening and enrolment logs. For enrolled patients, demographic and clinical data, including the amount of neurological impairment measured using the National Institutes of Health Stroke Scale (NIHSS; range 0–42, with higher scores indicating greater severity) were collected at the time of admission to hospital. Follow-up data were collected on clinical status, management, and outcomes at days 1 and 7 of treatment (or discharge or death if earlier) by hospital staff, and of outcomes to be ascertained at 6 months by independent staff. Brain imaging undertaken at presentation (the diagnostic scan), and at 24 h and 7 days of treatment in a subsample of 1619 patients (first seven patients in each of the usual care and intervention phases at each site) were uploaded to a secure central imaging server for analysis by trained physicians who were masked to treatment allocation. Results of the centrally adjudicated brain imaging will be presented in future publications.