SummaryBackgroundResults of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.MethodsFOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762.FindingsBetween Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months.InterpretationFluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.FundingUK Stroke Association and NIHR Health Technology Assessment Programme.

There is a need to improve clinical practice in obtaining valid consent for transfusion in line with existing national guidelines and local Trust policies, with emphasis on documentation within clinical records. Provision of patient information is an area particularly highlighted for action, and transfusion training for clinicians should be strengthened.

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Major haemorrhage protocols are aimed at optimizing the care of patients suffering life‐threatening bleeding. They should clearly set out the responsibilities of all of the staff involved including clinical and laboratory teams and other support staff with explicit lines of communication to support a prompt response without delays. The emphasis is on ready access to blood and components to limit coagulopathy in conjunction with definitive methods of controlling haemorrhage. High‐quality evidence for the early use of tranexamic acid strongly supports the inclusion of this drug in protocols for trauma and obstetric haemorrhage. Although national and international guidelines recommend the use of MHPs, they are not without drawbacks. Much of the evidence for their use comes from studies of trauma haemorrhage, and although the principles are widely applied to other clinical settings, there is a lack of data to guide practice in bleeding from other causes. Initial empirical replacement of red cells and plasma in fixed ratios largely based on experience from the military is now common in trauma, but this approach might result in overtreatment of some patients. As hypofibrinogenaemia is a poor prognostic factor, the inclusion of early fibrinogen replacement deserves attention and is the subject of active research. Further studies are examining the use of targeted transfusion strategies based on near‐patient testing, use of whole blood and chilled platelets, expanding indications for tranexamic acid and component use in the prehospital setting. MHPs should be reviewed regularly following local audit with ongoing update to reflect new research findings.

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