Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
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Clin. Appl. Thromb. Hemost. · Jan 2020
Multicenter StudySafety, Immunogenicity, and Hemostatic Efficacy of Nonacog Gamma in Patients With Severe or Moderately Severe Hemophilia B: A Continuation Study.
This phase 3, prospective, open-label, multicenter, continuation study (NCT01286779) investigated the use of a recombinant factor IX (FIX), nonacog gamma (BAX 326, RIXUBIS®) in patients with severe or moderately severe hemophilia B. The study population included 85 patients transitioning from a phase 1/3 pivotal study (NCT01174446), a pediatric study (NCT01488994), and 30 newly recruited patients, naïve to nonacog gamma. Patients received nonacog gamma as prophylaxis treatment (standard, modified or PK-tailored) or on-demand, as determined by the investigator. ⋯ The annualized bleeding rate was considerably lower during prophylactic treatment (median ABR of 1.3 in 108 patients) than during on-demand treatment (median ABR of 16.5 in 13 patients). These results show that in previously treated patients and nonacog gamma-naïve patients, long-term use of nonacog gamma had acceptable safety and tolerability, and was efficacious as a prophylactic treatment for the management of bleeding episodes. NCT01286779, EudraCT: 2010-022726-33.
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Clin. Appl. Thromb. Hemost. · Jan 2020
Deep Venous Thrombosis in COVID-19 Patients: A Cohort Analysis.
Deep venous thrombosis (DVT) is a severe complication of coronavirus disease 2019 (COVID-19). The purpose of this study was to study the prevalence, risk factors, anticoagulant therapy and sex differences of DVT in patients with COVID-19. The enrolled 121 hospitalized non-ventilator patients were confirmed positive for COVID-19. ⋯ Although anticoagulation therapy accelerated the recovery of lymphocytopenia in DVT patients, men DVT-COVID-19 patients with anticoagulant therapy showed significant higher CRP and neutrophil count vs. lymphocyte count (N/L) ratio, but showed lower lymphocyte counts compared to women DVT-COVID-19 patients. DVT is common in COVID-19 patients with high-risk factors, especially for older age and higher CRP and baseline D-dimer populations. It is important to consider sex differences in anticoagulant therapy among DVT-COVID-19 patients.
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Clin. Appl. Thromb. Hemost. · Jan 2020
Anti-Factor Xa Levels in Low-weight Surgical Patients Receiving Enoxaparin for Venous Thromboembolism Prophylaxis: A Prospective Cohort Study.
Enoxaparin is indicated for thromboprophylaxis in non-orthopedic surgical patients at a fixed dose of 40 mg daily. According to the US Food and Drug Administration's enoxaparin prescribing information, this dose exposes low-weight patients (males < 57 kg, females < 45 kg) to a higher risk of bleeding. This study aimed to determine the rate of achieving a prophylactic peak anti-factor Xa (AFXa) level in low-weight surgical patients using enoxaparin 30 mg daily. ⋯ Four venous thromboembolism events (3.3%) were observed in patients with sub-prophylactic peak AFXa levels (9.7%). Two-thirds of low-weight surgical patients achieved a prophylactic peak AFXa level using daily enoxaparin 30 mg. This dose is likely to provide adequate thromboprophylaxis in low-weight females.
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Clin. Appl. Thromb. Hemost. · Jan 2020
COVID-19 Associated Coagulopathy and Thrombotic Complications.
The SARS-CoV-2 virus caused a global pandemic within weeks, causing hundreds of thousands of people infected. Many patients with severe COVID-19 present with coagulation abnormalities, including increase D-dimers and fibrinogen. This coagulopathy is associated with an increased risk of death. ⋯ A better understanding of COVID-19 pathophysiology, in particular hemostatic disorders, will help to choose appropriate treatment strategies. A rigorous thrombotic risk assessment and the implementation of a suitable anticoagulation strategy are required. We review here the characteristics of COVID-19 coagulation laboratory findings in affected patients, the incidence of thromboembolic events and their specificities, and potential therapeutic interventions.