BACKGROUNDPrevious studies have suggested that fluoxetine could improve neurological recovery after stroke. The EFFECTS trial was designed to test the hypothesis that administration of fluoxetine for 6 months after acute stroke would improve functional outcome. METHODSEFFECTS was an investigator-led, parallel group, randomised, placebo-controlled trial that enrolled non-depressed stroke patients aged 18 years or older between two and 15 days after stroke onset in 35 hospitals in Sweden. The patients had a clinical diagnosis of ischemic or intracerebral haemorrhage with persisting focal neurological deficits at inclusion. A webbased randomisation system which incorporated a minimisation algorithm was used to allocate participants to fluoxetine 20 mg once daily or matching placebo capsules for 6 months with a ratio of 1:1. Patients, care providers, investigators, and outcomes assessors were masked to the allocation. The primary outcome was functional status, measured with the modified Rankin Scale (mRS) at 6 months. Patients were analysed according to their treatment allocation. EFFECTS is registered with ClinicalTrials.gov, number NCT02683213. FINDINGS Recruitment started 20 Oct 2014 and ended 28 June 2019, when the planned 1500 patients were included (750 to fluoxetine and 750 to placebo). mRS data were available for 737/750 (98%) in the fluoxetine group and 742/750 (99%) in the placebo group. The primary outcome -distribution across mRS categories-was neutral (common odds ratio adjusted for minimisation variables 0•94 [95% CI 0•78 to 1•13], p=0•42). Fluoxetine reduced depression
Well-managed warfarin therapy is associated with a low risk of complications and is still a valid alternative for prophylaxis of AF-associated stroke. Therapy should be closely monitored for patients with renal failure, concomitant aspirin use, and poor INR control.
ABSTRACT. Stroke events are being registered in 27 of the MONICA collaborating centres. Coding of test cases has shown the greatest discrepancies in coding of the type of stroke (different pathoanatomical diagnoses) and of the diagnostic category (whether a definite stroke has occurred or not), 23 % and 14 % discrepancies respectively. A check for completeness of stroke registration at the Northern Sweden MONICA Center showed that more than 91 % of the events were retrieved by routine registration procedures. Measures to reduce the discrepancies in coding between centres and to check for completeness of data are suggested. In many centres, the number of stroke events below 65 years of age is too small to permit meaningful analyses. By including also stroke events in the 65–74 year age range, the number of fatal events in the Northern Sweden MONICA area increased by 195 % and non‐fatal events by 149 %. Many other MONICA centres have also extended their upper age limit for the registration of stroke events, thus improving the preconditions for statistical evaluations of the long‐term changes in stroke incidence.
SUMMARY Rapid hemodilution in the early phase of ischemic stroke by the combination of venesection (250-650 ml during the first 2 days) and administration of low-molecular weight dextran was evaluated in a prospective controlled trial. Fifty-two patients were randomized to hemodilution therapy and 50 to a control group; the two groups were comparable in important prognostic variables. Mean hemoglobin was reduced from 147 to 127 g/1, hematocrit from 43 to 37% and, in a subsample of patients, whole-blood viscosity at a shear rate of 23 sec' 1 from 7.0 to 4.3 cps over the first 2 days. Hemodilution was then maintained by repeated dextran infusions.Of the hemodiluted patients, 85% improved in neurological scoring over the first 10 days as compared to 64% of the control patients (p < 0.025). The case fatality rate during the first 3 months was little affected by hemodilution. Among the survivors, 8% of the hemodiluted and 31% of the non-hemodiluted patients were unable to walk at 3 months. The proportion of surviving patients still hospitalized at the 3-month follow-up was 13% in the hemodilution group and 39% in the control group (p < 0.01).The combination of venesection and dextran 40 administration is thus an unsophisticated but effective way to achieve rapid hemodilution in patients with acute cerebral infarction, and it improves the overall clinical outcome over the first 3 months.Stroke Vol 15, No 6, 1984
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