Thromb Haemostasis
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Randomized Controlled Trial
Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban: a randomised crossover ex vivo study in healthy volunteers.
The new anticoagulants dabigatran and rivaroxaban can be responsible for haemorrhagic complications. As for any anticoagulant, bleeding management is challenging. We aimed to test the effect of all putative haemostatic agents on the anticoagulant activity of these new drugs using thrombin generation tests. ⋯ For both anticoagulants, lower doses of FEIBA, corresponding to a quarter to half the dose usually used, have potential reversal profile of interest. In conclusion, some non-specific reversal agents appear to be able to reverse the anticoagulant activity of rivaroxaban or dabigatran. However, clinical evaluation is needed regarding haemorrhagic situations, and a meticulous risk-benefit evaluation regarding their use in this context is required.
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Increased red blood cell distribution width (RDW), which is a marker of anisocytosis, is associated with mortality and cardiovascular events in the general population and in patients with heart failure or coronary heart disease. We investigated whether RDW in acute cerebral infarction is predictive of functional outcome and mortality. A total of 847 consecutive patients with first-ever acute cerebral infarction who presented to the emergency department within seven days of symptom onset were enrolled in this study. ⋯ The addition of RDW to a survival model significantly increased predictability for survival across the entire follow-up period (weighted average of the area-under the curves, 0.858 vs. 0.841, p<0.05). In conclusion, higher RDW measured in cases of acute stage cerebral infarction was associated with poor functional outcome and mortality. RDW may be used as a biomarker for the prediction of long-term outcomes in patients with acute cerebral infarction.
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Identification of patients with acute pulmonary embolism (PE) who might be at risk of circulatory collapse by using a fast, automated system is highly desired. It was our objective to investigate whether automated cardiac volumetric analysis following computerised tomographic pulmonary angiography (CTPA) is useful to identify increased clot load and adverse prognosis in patients with acute PE. We retrospectively analysed a consecutive series of non-gated CTPA studies of 124 patients with acute PE and 43 controls. ⋯ Results for the combined outcome of mortality or ICU admission that fell in the upper tertile of the right atrial and right ventricular volumes yielded hazard ratios of 3.9 and 3.3, respectively, compared to those in the lower tertile. RV/LV diameter ratio did not correlate with outcome. In conclusion, adverse outcome and significant pulmonary clot load in patients with acute PE are associated with a volume shift towards right heart cavities, which correlates to prognosis better than the CT-measured RV/LV diameter ratio, suggesting the advantage of using fast fully automatic volumetric analysis to identify patients at risk.
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Randomized Controlled Trial
Edoxaban administration following enoxaparin: a pharmacodynamic, pharmacokinetic, and tolerability assessment in human subjects.
Edoxaban is an oral direct factor (F)Xa inhibitor in advanced stages of clinical development. The primary objective of the present study was to assess the pharmacodynamics (PD) and safety of enoxaparin 1 mg/kg followed 12 hours (h) post-dose by edoxaban 60 mg, which is the regimen being used in the phase III study of edoxaban for the treatment of venous thromboembolism (Hokusai-VTE). This was a phase I, open-label, randomised, four-period, four-treatment cross-over study. ⋯ As expected, neither edoxaban nor enoxaparin significantly altered the PK of the other drug. There were no serious adverse events during the study. It is concluded that a 60-mg dose of edoxaban can be safely administered 12 h following enoxaparin 1 mg/kg.