Organised stroke unit care is provided by multidisciplinary teams that exclusively manage stroke patients in a ward dedicated to stroke patients, with a mobile stroke team or within a generic disability service (mixed rehabilitation ward). To assess the effect of stroke unit care compared with alternative forms of care for people following a stroke. We searched the trials registers of the Cochrane Stroke Group (January 2013) and the Cochrane Effective Practice and Organisation of Care (EPOC) Group (January 2013), MEDLINE (2008 to September 2012), EMBASE (2008 to September 2012) and CINAHL (1982 to September 2012). In an effort to identify further published, unpublished and ongoing trials, we searched 17 trial registers (January 2013), performed citation tracking of included studies, checked reference lists of relevant articles and contacted trialists. Randomised controlled clinical trials comparing organised inpatient stroke unit care with an alternative service. After formal risk of bias assessment, we have now excluded previously included quasi-randomised trials. Two review authors initially assessed eligibility and trial quality. We checked descriptive details and trial data with the co-ordinators of the original trials. We included 28 trials, involving 5855 participants, comparing stroke unit care with an alternative service. More-organised care was consistently associated with improved outcomes. Twenty-one trials (3994 participants) compared stroke unit care with care provided in general wards. Stroke unit care showed reductions in the odds of death recorded at final (median one year) follow-up (odds ratio (OR) 0.87, 95% confidence interval (CI) 0.69 to 0.94; P = 0.005), the odds of death or institutionalised care (OR 0.78, 95% CI 0.68 to 0.89; P = 0.0003) and the odds of death or dependency (OR 0.79, 95% CI 0.68 to 0.90; P = 0.0007). Sensitivity analyses indicated that the observed benefits remained when the analysis was restricted to securely randomised trials that used unequivocally blinded outcome assessment with a fixed period of follow-up. Outcomes were independent of patient age, sex, initial stroke severity or stroke type, and appeared to be better in stroke units based in a discrete ward. There was no indication that organised stroke unit care resulted in a longer hospital stay. Stroke patients who receive organised inpatient care in a stroke unit are more likely to be alive, independent, and living at home one year after the stroke. The benefits were most apparent in units based in a discrete ward. We observed no systematic increase in the length of inpatient stay.