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prothrombin complex concentrates

Ling Xue, Nick Holford, Xiao-Liang Ding, Zhen-Ya Shen, Chen-Rong Huang, Hua Zhang, Jing-Jing Zhang, Zhe-Ning Guo, Cheng Xie, Ling Zhou, Zhi-Yao Chen, Lin-Sheng Liu, Li-Yan Miao
AIMS: The aims of this study are to apply a theory based mechanistic model to describe the pharmacokinetics (PK) and pharmacodynamics (PD) of S- and R-warfarin. METHODS: Clinical data were obtained from 264 patients. Total concentrations for S- and R-warfarin were measured by ultra-high performance liquid tandem mass spectrometry. Genotypes were measured using pyrosequencing. A sequential population pharmacokinetic parameter with data method was used to describe the international normalized ratio (INR) time course...
October 20, 2016: British Journal of Clinical Pharmacology
Marco Ranucci, Ekaterina Baryshnikova, Valeria Pistuddi, Lorenzo Menicanti, Alessandro Frigiola
OBJECTIVES: Postoperative bleeding in cardiac surgery remains an important complication, leading to increased morbidity and mortality. Different interventions are possible to prevent/treat postoperative bleeding. The present study aims to investigate the effectiveness of these interventions in a real-world scenario. METHODS: This is a retrospective study based on 19 670 consecutive adult cardiac surgery patients operated from 2000 to 2015. During the study period, the following interventions have been applied and tested for effectiveness with a before versus after analysis: thromboelastography (TEG)-based diagnosis and treatment in actively bleeding patients; platelet function tests (PFTs); timing of surgery based on PFTs; fresh frozen plasma (FFP)-free strategy using prothrombin complex concentrate and fibrinogen concentrate...
October 17, 2016: Interactive Cardiovascular and Thoracic Surgery
A Shaun Rowe, Pinky S Mahbubani, Mason H Bucklin, Christopher T Clark, Leslie A Hamilton
STUDY OBJECTIVE: To evaluate the efficacy and safety of an activated 4-factor prothrombin complex concentrate (aPCC) versus plasma for the reversal of warfarin-associated hemorrhage. DESIGN: Single-center, retrospective cohort analysis of adult patients with warfarin-associated hemorrhage treated with either aPCC or plasma. PATIENTS: Patients received either aPCC or plasma as treatment for warfarin-associated hemorrhage between January 1, 2011 and July 1, 2013...
October 11, 2016: Pharmacotherapy
Fuat H Saner, Carmen Kirchner
BACKGROUND: Patients with end-stage liver disease (ESLD) are assumed to be at high risk of bleeding when undergoing any kind of invasive intervention (any kind of operation, including transplantation or minimally invasive interventions). Both bleeding and thrombosis are associated with a poor outcome. METHODS: A selective literature research was conducted with the following key words: 'cirrhosis', 'coagulation', 'bleeding', 'INR' (international normalized ratio), 'aPTT' (activated partial thromboplastin time), and 'thrombocytopenia'...
August 2016: Visc Med
N Appleby, E Groarke, M Crowley, F A Wahab, A M McCann, L Egan, D Gough, G McMahon, D O'Donghaile, D O'Keeffe, N O'Connell
BACKGROUND: Real-world studies of the emergency reversal of warfarin using 4-factor prothrombin complex concentrate (PCC) report unwarranted delays. The delay to receiving PCC was ≥ 8 h in 46·7% of patients with warfarin-associated bleeding (PWAB) treated with a variable PCC dosing protocol in our retrospective audit. OBJECTIVE: To report the impact of a simplified PCC dosing protocol on the interval to reversal of anticoagulation. METHODS: We developed a PCC dosing protocol standardising the initial PCC dose and simplifying dosing calculations...
October 7, 2016: Transfusion Medicine
Murat Kose, Oguz Kagan Bakkaloglu, Shirkhan Amikishiyev, Timur Selcuk Akpınar, Basak Saracoglu, Tugce Akcan, Melike Oktem, Mustafa Nuri Yenerel, Kerim Güler, Tufan Tükek
Acquired hemophilia is a relatively rare clinical presentation, and most cases present with acquired FVIII inhibitor. The co-occurrence of inhibitors to multiple coagulation factors is uncommon. These autoantibodies may induce spontaneous life-threatening bleeding in patients who have had no previous bleeding disorder. Herein, we present a patient with postpartum acquired FVIII and FIX inhibitors who developed intramuscular hematoma and hemothorax during follow-up. She was then treated with activated prothrombin complex concentrate and methylprednisolone...
October 5, 2016: Acta Haematologica
Menno V Huisman, John Fanikos
As expected with all antithrombotic agents, there is a risk of bleeding complications in patients receiving direct oral anticoagulants (DOACs) because of the DOAC itself, acute trauma, invasive procedures, or underlying comorbidities. For many bleeding events, a prudent course of action will be to withdraw the DOAC, then "wait and support" the patient, with the expectation that the bleeding event should resolve with time. Likewise, DOAC therapy may be interrupted ahead of a planned procedure, the stopping time being dependent on the agent involved and the patient's renal function...
September 28, 2016: American Journal of Emergency Medicine
D Lee, S Nayak, S W Martin, A C Heatherington, P Vicini, F Hua
BACKGROUND: Prothrombin fragment 1.2 (PF12), thrombin-anti-thrombin III complex (TAT) and D-dimer can be detected in plasma from non-bleeding hemostatic normal or hemophilia subjects. They are often used as safety or pharmacodynamic biomarkers for hemostatic modulating therapies in clinic and provide insights into in vivo coagulation activity. OBJECTIVES: To develop a Quantitative Systems Pharmacology (QSP) model of blood coagulation network to describe in vivo biomarkers including PF12, TAT and D-dimer under non-bleeding condition...
September 26, 2016: Journal of Thrombosis and Haemostasis: JTH
Karen S Brown, Hamim Zahir, Michael A Grosso, Hans J Lanz, Michele F Mercuri, Jerrold H Levy
BACKGROUND: Four nonvitamin K antagonist oral anticoagulants (NOACs) are approved for the prevention of stroke in patients with nonvalvular atrial fibrillation and for the treatment of venous thromboembolism. These include the direct thrombin inhibitor dabigatran and the direct factor Xa inhibitors rivaroxaban, apixaban, and edoxaban. Bleeding is a complication for all anticoagulants and concerns regarding bleeding risk and the suitability of effective reversal strategies may be a barrier to their prescription...
September 23, 2016: Critical Care: the Official Journal of the Critical Care Forum
Mina Golestani, Peyman Eshghi, Hamid Reza Rasekh, Abdoll Majid Cheraghali, Jamshid Salamzadeh, Majid Naderi, Mohammad Reza Managhchi, Hamid Hoorfar, Gholam Reza Toogeh, Ali Imani, Mohammad Taghi Khodayari, Behnaz Habibpanah, Razieh Hantooshzadeh
Nowadays, bypassing agents such as recombinant activated factor VII (rFVIIa) and activated prothrombin complex concentrates (aPCC) are used to treat bleeding episodes in the Hemophilia patients with inhibitors. AryoSeven® is an Iranian biogeneric rFVIIa with homogeneity of efficacy and the nature to NovoSeven in a comparative trial. The current clinical trial aimed to evaluate the cost-effectiveness of FEIBA and AryoSeven® by Decision Analytic Model according to the Iranian healthcare system. An open label, multi-center, cross-over clinical trial was designed...
2016: Iranian Journal of Pharmaceutical Research: IJPR
Jack E Ansell
The vitamin K antagonists (VKAs) are associated with a significant rate of major and fatal bleeding complications. The new direct oral anticoagulants (DOACs), even though having a better bleeding profile than the VKAs, are still associated with serious bleeding. The anticoagulation induced by the VKAs can be reversed with both vitamin K and prothrombin complex concentrates, whereas the DOACs were developed without specific reversal agents. Although there is controversy around the necessity of a reversal agent, most clinicians agree that having a reversal agent for the DOACs would be beneficial...
October 2016: Hematology/oncology Clinics of North America
Wan-Ting Huang, William C Cang, Katrina L Derry, James R Lane, Annette von Drygalski
A 4-factor prothrombin complex concentrate (4F-PCC, Kcentra®) was recently approved in the United States for the reversal of vitamin K antagonist-associated major bleeding, but it is often used to reverse coagulopathy in patients with liver disease (LD). This single-center, retrospective study analyzed the efficacy and safety of 4F-PCC administered in patients with and without LD. Prothrombin time/International Normalized Ratio (PT/INR) reversal with 4F-PCC was attempted in 85 patients; LD was documented in 31 patients...
September 14, 2016: Clinical and Applied Thrombosis/hemostasis
B Schenk, P Würtinger, W Streif, W Sturm, D Fries, M Bachler
BACKGROUND: In major bleeding events, the new direct oral anticoagulants pose a great challenge for physicians. The aim of the study was to test for ex vivo reversal of the direct oral anticoagulant rivaroxaban with various non-specific reversal agents: prothrombin complex concentrate (PCC), activated prothrombin complex concentrate (aPCC), recombinant activated factor VII (rFVIIa), and fibrinogen concentrate (FI). METHODS: Blood was obtained from healthy volunteers and from patients treated with rivaroxaban...
September 13, 2016: British Journal of Anaesthesia
J Bartko, C Schoergenhofer, M Schwameis, N Buchtele, J Wojta, G Schabbauer, L Stiebellehner, B Jilma
BACKGROUND: Activation of local and systemic coagulation is a common finding in patients with pneumonia. There is evidence that glucocorticoids have procoagulant activity in the circulation, particularly in the context of inflammation. Effects of glucocorticoids on local pulmonary coagulation have not been investigated yet. OBJECTIVE: A human model of lung inflammation based on the local instillation of endotoxin was used to investigate whether glucocorticoids may alter pulmonary coagulation...
September 13, 2016: Journal of Thrombosis and Haemostasis: JTH
Xinliang Guan, Jiachen Li, Ming Gong, Feng Lan, Hongjia Zhang
Coagulopathy is still a frequent complication in the surgical treatment of acute aortic dissection. However, the physiopathology of surgically induced coagulopathy has never been systematically and comprehensively studied in patients with acute aortic dissection. The aim of the present study was to describe the perioperative hemostatic system in patients with acute aortic dissection.The 87 patients who underwent aortic arch surgery for acute Stanford type A aortic dissection from January 2013 to September 2015 were enrolled in this study...
September 2016: Medicine (Baltimore)
Menno V Huisman, John Fanikos
As expected with all antithrombotic agents, there is a risk of bleeding complications in patients receiving direct oral anticoagulants (DOACs) because of the DOAC itself, acute trauma, invasive procedures, or underlying comorbidities. For many bleeding events, a prudent course of action will be to withdraw the DOAC, then "wait and support" the patient, with the expectation that the bleeding event should resolve with time. Likewise, DOAC therapy may be interrupted ahead of a planned procedure, the stopping time being dependent on the agent involved and the patient's renal function...
November 2016: American Journal of Medicine
Y E Chee, S E Liu, M G Irwin
Management of acute coagulopathy and blood loss during major vascular procedures poses a significant haemostatic challenge to anaesthetists. The acute coagulopathy is multifactorial in origin with tissue injury and hypotension as the precipitating factors, followed by dilution, hypothermia, acidemia, hyperfibrinolysis and systemic inflammatory response, all acting as a self-perpetuating spiral of events. The problem is confounded by the high prevalence of antithrombotic agent use in these patients and intraoperative heparin administration...
September 2016: British Journal of Anaesthesia
Jacqueline Pratt Cleary, Laura Hodge, Brittany Palmer, Christopher J Barreiro, Amanda Ingemi
BACKGROUND All patients with a ventricular assist device (VAD) awaiting heart transplantation are anticoagulated with warfarin to prevent thromboembolism. The use of 4 factor prothrombin complex concentrate (PCC4, Kcentra®) for anticoagulation reversal prior to surgery may include benefits such as quicker reversal, longer duration of action, and a reduction in total volume of blood products used compared to other reversal practices. The study objective is to evaluate benefits of using an anticoagulation reversal protocol featuring PCC4, over standard of care in heart transplant patients requiring anticoagulation...
2016: Annals of Transplantation: Quarterly of the Polish Transplantation Society
Nasiredin Sadeghi, Massimo Iacobelli, Behroz Vaziri, Daniel Kahn, Debra Hoppensteadt, Nil Guler, Jawed Fareed
Recombinant factor VIIa (rFVIIa) is used in the management of bleeding in patients with hemophilia. A generic biosimilar version of NovoSeven is also developed (AryoSeven). To compare the activation profile of NovoSeven and AryoSeven, 2 commercially available protein complex concentrates (PCCs) were used. Profilnine activated by RecombiPlasTin 2G resulted in conversions of prothrombin to prethrombin and thrombin at 5 to 30 minutes. However, addition of rFVIIa at final concentration range of 0.25 to 0.5 µg/mL to the same mixture resulted in total conversion of prothrombin to thrombin with a doublet at 36 kDa...
August 23, 2016: Clinical and Applied Thrombosis/hemostasis
Jennifer O Kwon, Robert MacLaren
STUDY OBJECTIVE: To evaluate fresh-frozen plasma (FFP), four-factor prothrombin complex concentrates (PCCs), and recombinant factor VIIa (rFVIIa) for lowering international normalized ratio (INR) and facilitating procedures in critically ill patients with hepatic impairment. DESIGN: Retrospective cohort study. SETTING: Intensive care units at a large university-affiliated teaching hospital. PATIENTS: Forty-five adults with hepatic impairment who were admitted between September 1, 2011, and December 31, 2015, and had an admission INR of 1...
October 2016: Pharmacotherapy
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