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.
We hereby describe a 42-year-old lady who developed vertebral artery dissection following a head injury. The clinical features and management of the condition are discussed.
Ischaemic stroke can result in approximately 2 million brain neurones being damaged for each minute that it is left untreated. Various trials and studies such as the National Institute of Neurologic Disorders (NINDS) trial, the European Cooperative Acute Stroke Study (ECASS), ECASS II, and the Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke (ATLANTIS) study have clearly demonstrated the beneficial effects of intravenous tissue plasminogen activator (tPA) for treatment of acute stroke.Therefore to minimise damage and improve clinical outcome, we need to identify patients who present within 4.5 hours of symptom onset and reduce the time taken to adminster a thrombolytic agent. This time is commonly referred to as the ‘door to needle’ (DTN) time.Our standard, set by the Clinical Commissioning Group (CCG) is to achieve a median time of scanning and thrombolysis within 55 minutes from the time that the patient enters the hospital. The aim of our QIP was to collect data on what the DTN time was during November 2015, December 2015, and January 2016 and to evaluate how this can be improved after each month.This Quality Improvement Project in the DTN time in patients for thrombolysis has identified areas in the pathway that leads to delays. One major contributing factor is the time for a doctor to come and assess and administer the thrombolytic agent to the patient. Change was implemented by ensuring that the core medical trainee on call is allocated to respond as a priority to all possible thrombolysis calls. This has resulted in a reduction of mean DTN time, from 74 minutes in November to 43 minutes in January. As well as improving patient outcomes, it is proposed that the implementation of change has benefitted the training experience and development of key skills of the core medical trainees.
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