Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis
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Blood Coagul. Fibrinolysis · Mar 2018
Multicenter StudySafety and effectiveness of high-dose, weight-based factor VIII inhibitor bypassing activity for warfarin-induced life-threatening bleeding.
: Previous studies suggest low, fixed-dose regimens of activated prothrombin complex concentrate [factor VIII inhibitor bypassing activity (FEIBA); 500 U for international normalized ratio (INR) < 5; 1000 U for INR > 5] is effective for reversal of warfarin-induced life-threatening bleeds. Little data are available on the use of high-dose, weight-based FEIBA for this indication. The objective of this study was to evaluate effectiveness and safety of high-dose, weight-based FEIBA (50 U/kg) vs. frozen plasma alone in this population. ⋯ Thromboembolic events occurred in nine (16.7%) patients (FEIBA n = 5; plasma n = 4); (P = 1.0). Mortality was similar in both groups (FEIBA 33% vs. frozen plasma 15%; P = 0.2). The use of high-dose, weight-based FEIBA resulted in faster time to reversal of warfarin-induced coagulopathy compared with frozen plasma alone and showed a similar safety profile.
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Blood Coagul. Fibrinolysis · Jul 2016
Multicenter Study Observational StudyGlobal Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate).
This prospective, Post-Authorization Safety Surveillance (PASS) study was carried out in patients with hemophilia A or B and inhibitors treated with FEIBA for 1 year to collect real-world data on safety and effectiveness of FEIBA. The study followed a cohort design and did not make stipulations on treatment or observation schedule, as it was designed to observe routine medical practices based on physicians' treatment decisions, including whether patients received on-demand or prophylaxis with FEIBA. The attending physician maintained documentation, including medical records, laboratory reports, adverse event reports, and so on and a subject diary was used. ⋯ Sixty-nine patients (85.2%) had hemophilia A, two had (2.5%) hemophilia B, and ten (12.3%) had acquired hemophilia A. At baseline 45 patients (55.6%) were prescribed prophylaxis and 36 (44.6%) on-demand treatment. This study was novel in following safety and effectiveness in 'real world' on-demand and prophylactic use of FEIBA, and was able to collect data in these rare patients under routine clinical practice.
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Blood Coagul. Fibrinolysis · Jul 2014
Review Multicenter StudyLong-term outcomes after pulmonary embolism: current knowledge and future research.
In this article, we provide the rationale for the ELOPE (Evaluation of Long-term Outcomes after Pulmonary Embolism) Study, a prospective, observational, multicenter cohort study of patients with a newly diagnosed, first episode of pulmonary embolism (www.clinicaltrials.govNCT01174628) that aims to identify clinical, anatomic, physiologic and biomarker determinants of poor outcome after pulmonary embolism. Pulmonary embolism, the most serious form of venous thromboembolism (VTE), leads to the hospitalization or death of over 30,000 Canadians, 225,000 Americans and 300,000 Europeans each year, numbers that have risen over the past decade. Although numerous studies have evaluated optimal approaches to the diagnosis and treatment of pulmonary embolism, their focus has primarily been on short-term outcomes such as mortality and recurrent VTE in the days, weeks or months after pulmonary embolism diagnosis. ⋯ Residual pulmonary vascular abnormalities on follow-up imaging and echocardiogram are frequent in pulmonary embolism patients, but the clinical significance of these abnormalities is poorly understood. Whether initial and/or residual clot burden, recurrent pulmonary embolism, altered pulmonary artery or right ventricular hemodynamics or other prognostic factors such as biomarker levels contribute to long-term morbidity after pulmonary embolism is as yet unknown. The ELOPE Study will describe and identify the predictors of long-term outcomes after pulmonary embolism in the setting of a rigorous, multicenter cohort study in which long-term clinical, anatomic, physiologic and functional sequelae such as quality of life, return to work and loss of productivity after pulmonary embolism are systematically evaluated.
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Blood Coagul. Fibrinolysis · Jan 2014
Multicenter Study Observational StudyPlatelet aggregation following trauma: a prospective study.
We aimed to elucidate platelet function in trauma patients, as it is pivotal for hemostasis yet remains scarcely investigated in this population. We conducted a prospective observational study of platelet aggregation capacity in 213 adult trauma patients on admission to an emergency department (ED). Inclusion criteria were trauma team activation and arterial cannula insertion on arrival. ⋯ An aggregation value of 145 IU by TRAP significantly identified death due to cerebral injury (sensitivity 71% and specificity 76%, P < 0.01) by receiver operating characteristic-curve analysis; the corresponding value of platelet counts for massive transfusion was 189 × 10/l (sensitivity 86%, specificity 75%, P < 0.01). We concluded there was no simple relationship between platelet aggregation and injury severity. Our results indicate that high platelet aggregation values are associated with fatality of cerebral injury.
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Blood Coagul. Fibrinolysis · Apr 2012
Multicenter StudyProthrombin complex concentrate (Octaplex): a Portuguese experience in 1152 patients.
In emergency/clinical practice it is often necessary to restore the balance of blood coagulation: the rapid reversal of oral anticoagulant therapy (OAT) is crucial in cases of serious acute bleeding and emergency surgery in patients with high international normalized ratios (INRs). Coagulation can be normalized via the application of haemostatic products, including fresh frozen plasma (FFP) or prothrombin complex concentrates (PCCs). Guidelines recommend PCCs for the reversal of OAT in preference to FFP in patients with major/life-threatening bleeding and high INRs. ⋯ No adverse drug reactions or thromboembolic events were reported. Octaplex effectively and significantly reduces INR values in patients requiring the restoration of blood coagulation. It effectively reverses the effect of OAT and was efficacious in the majority of bleeding episodes in patients with liver dysfunction.