Using the nationwide Swedish Stroke Register, Riksstroke, we studied the relationship between the timing Background and Purpose-This study aims to provide observational data on the relationship between the timing of antithrombotic treatment and the competing risks of severe thrombotic and hemorrhagic events in a cohort of Swedish patients with atrial fibrillation and intracerebral hemorrhage (ICH). Methods-Patients with atrial fibrillation and a first-ever ICH were identified in the Swedish Stroke Register, Riksstroke, 2005Riksstroke, to 2012. Riksstroke was linked with other national registers to find information on treatment, comorbidity, and outcome. The optimal timing of treatment in patients with low and high thromboembolic risk was described through cumulative incidence functions separately for thrombotic and hemorrhagic events and for the combined end point vascular death or nonfatal stroke. Results-The study included 2619 ICH survivors with atrial fibrillation with 5759 person-years of follow-up. Anticoagulant treatment was associated with a reduced risk of vascular death and nonfatal stroke in high-risk patients with no significantly increased risk of severe hemorrhage. The benefit seemed to be greatest when treatment was started 7 to 8 weeks after ICH. For high-risk women, the total risk of vascular death or stroke recurrence within 3 years was 17.0% when anticoagulant treatment was initiated 8 weeks after ICH and 28.6% without any antithrombotic treatment (95% confidence interval for difference, 1.4%-21.8%). For high-risk men, the corresponding risks were 14.3% versus 23.6% (95% confidence interval for difference, 0.4%-18.2%). Conclusions-This nationwide observational study suggests that anticoagulant treatment may be initiated 7 to 8 weeks after ICH in patients with atrial fibrillation to optimize the benefit from treatment and minimize risk.
With clinical trials under pressure to produce more convincing results faster, we reexamine relative efficiencies for the semiparametric comparison of cause-specific rather than all-cause mortality events, observing that in many settings misclassification of cause of failure is not negligible. By incorporating known misclassification rates, we derive an adapted logrank test that optimizes power when the alternative treatment effect is confined to the cause-specific hazard. We derive sample size calculations for this test as well as for the corresponding all-cause mortality and naive cause-specific logrank test which ignores the misclassification. This may lead to new options at the design stage which we discuss. We reexamine a recently closed vaccine trial in this light and find the sample size needed for the new test to be 32% smaller than for the equivalent all-cause analysis, leading to a reduction of 41 224 participants.
Our pragmatic, if highly conservative, estimates quantify the potential for prevention of VAP and BSI in routine conditions, assuming that variation in infection incidence between ICUs can be eliminated with improved quality of care, apart from variation attributable to differential case mix.
The purpose of this study was to evaluate whether NaHCO3, administered via a 9-h stacked loading protocol (i.e. repeated supplementation with small doses in order to obtain a gradual increase in blood [HCO3 -]), has an ergogenic effect on repeated all-out exercise. Twelve physically active males were randomly assigned to receive either NaHCO3 (BIC) or placebo (PL) in a double-blind cross-over design. NaHCO3 supplementation was divided in three identical 3-h cycles: a 6.3 g bolus at the start, followed by 2.1 g doses at +1-h and +2-h, yielding a total NaHCO3 intake of 0.4 g·kg−1 BM over 9-h. At the end of each cycle, participants performed 2-min all-out cycling. Capillary blood samples were analyzed for [HCO3 -], pH and [La-]. Pre-exercise blood [HCO3 -] in PL decreased from 25.6±0.2 mmol·L−1 in bout 1 to 23.6±0.2 mmol·L−1 in bout 4, while increasing from 25.5±0.2 to 31.2±0.4 mmol·L−1 in BIC (P<0.05). Concomitantly, pre-exercise pH values gradually decreased in PL (from 7.41±0.00 to 7.39±0.01) and increased in BIC (from 7.41±0.01 to 7.47±0.01; P<0.05). Mean power output of the four bouts was higher in BIC (428±20 W) than in PL (420±20 W; P<0.05). The ergogenic effect on repeated all-out exercise occurred in the absence of gastrointestinal distress.
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