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prothrombin complex concentrates

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https://www.readbyqxmd.com/read/28901221/direct-oral-anticoagulant-reversal-how-when-and-issues-faced
#1
Mikhail S Dzeshka, Daniele Pastori, Gregory Y H Lip
The number of atrial fibrillation (AF) patients requiring thrombo-prophylaxis with oral anticoagulation is greatly increasing. The introduction of non-vitamin K oral anticoagulants (NOACs) in addition to standard therapy with dose-adjusted warfarin has increased the therapeutic options for AF patients. Despite a generally better safety profile of the NOACs, the risk of major bleedings still persists, and the management of serious bleeding is a clinical challenge. Areas covered: In the current review, risk of major bleeding in patients taking NOACs and general approaches to manage bleeding depending on severity, with a particular focus on specific reversal agents, are discussed...
September 13, 2017: Expert Review of Hematology
https://www.readbyqxmd.com/read/28888219/factor-xa-inhibition-by-rivaroxaban-in-the-trough-steady-state-can-significantly-reduce-thrombin-generation
#2
Shigeo Horinaka, Rie Sugawara, Yutaka Yonezawa, Toshihiko Ishimitsu
AIMS: The aim of the present study was to demonstrate evidence of reduced thrombin generation at the trough plasma rivaroxaban concentration. METHODS: A single-centre, prospective, non-randomised, drug intervention, self-controlled study was conducted in 51 anticoagulation therapy-naïve patients with non-valvular atrial fibrillation. Plasma rivaroxaban concentration was measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) and anti-factor Xa chromogenic assay...
September 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28887767/management-of-spontaneous-intracerebral-hemorrhage
#3
REVIEW
Roland Veltkamp, Jan Purrucker
PURPOSE OF REVIEW: We review the current evidence for medical and surgical treatments of spontaneous intracerebral hemorrhage (ICH). RECENT FINDINGS: Therapy with hemostatic agents (e.g. factor VIIa and tranexamic acid) if started early after bleeding onset may reduce hematoma expansion, but their clinical effectiveness has not been shown. Rapid anticoagulation reversal with prothrombin concentrates (PCC) plus vitamin K is the first choice in vitamin K antagonist-related ICH...
September 8, 2017: Current Neurology and Neuroscience Reports
https://www.readbyqxmd.com/read/28857856/theoretical-modeling-of-coagulation-management-with-therapeutic-plasma-or-prothrombin-complex-concentrate
#4
Herbert Schöchl, Oliver Grottke, Ken Sutor, Kieron Dony, Martin Schreiber, Marco Ranucci, Peter W Collins
Prothrombin complex concentrates (PCCs) have been associated with a possible risk of thromboembolic complications, potentially attributable to an increased ratio of the plasma concentration of factor II (FII) to antithrombin (AT). We developed a mathematical model to examine the relationship between amounts of PCC or therapeutic plasma administered, and plasma levels of FII and AT. The model showed that PCC produces substantial increases in plasma levels of FII but only small changes in AT, increasing the FII:AT ratio...
August 24, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28857806/reversing-dabigatran-anticoagulation-with-prothrombin-complex-concentrate-versus-idarucizumab-as-part-of-multimodal-hemostatic-intervention-in-an-animal-model-of-polytrauma
#5
Markus Honickel, Till Braunschweig, Rolf Rossaint, Christian Stoppe, Hugo Ten Cate, Oliver Grottke
BACKGROUND: Although idarucizumab is the preferred treatment for urgent dabigatran reversal, it is not always available. Prothrombin complex concentrate (PCC) may be an alternative and, with bleeding in trauma, additional hemostatic therapy may be required. The authors investigated multimodal treatment in a preclinical polytrauma model. METHODS: Dabigatran etexilate (30 mg/kg twice daily) was given orally to 45 male pigs for 3 days. On day 4, animals received a dabigatran infusion before blunt liver injury and bilateral femur fractures...
August 30, 2017: Anesthesiology
https://www.readbyqxmd.com/read/28857805/precision-correction-of-coagulopathy-or-prothrombin-complex-concentrates-reversal-options-for-dabigatran-following-trauma
#6
Matthew D Neal, Jerrold H Levy
No abstract text is available yet for this article.
August 30, 2017: Anesthesiology
https://www.readbyqxmd.com/read/28846831/reversal-of-apixaban-anticoagulation-by-4-factor-prothrombin-complex-concentrates-in-healthy-subjects-a-randomized-3-period-crossover-study
#7
Yan Song, Zhaoqing Wang, Itay Perlstein, Jessie Wang, Frank LaCreta, Robert J A Frost, Charles Frost
BACKGROUND: Currently, there is no approved reversal agent for direct factor Xa (FXa) inhibitors; however, several agents are under investigation, including prothrombin complex concentrates (PCCs). OBJECTIVE: This open-label, randomized, placebo-controlled, 3-period crossover study assessed the effect of two 4-factor PCCs on apixaban pharmacodynamics and pharmacokinetics in 15 healthy subjects. METHODS: Subjects received apixaban 10 mg twice daily for 3 days...
August 28, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28842519/effect-of-pharmacy-management-on-turnaround-time-of-4-factor-prothrombin-complex-concentrate
#8
Eileen Langstraat, Ashley Martinelli, Brian Spoelhof, Shailly Shah
PURPOSE: The change in turnaround time of 4-factor prothrombin complex concentrate (PCC) when managed by the pharmacy department compared to blood bank management was evaluated. METHODS: A retrospective analysis evaluated blood bank versus pharmacy management of PCC. Blood bank management was evaluated from November 2014 to November 2015, and pharmacy management was evaluated from December 2015 to July 2016. Chart review was performed on all patients who received PCC during these study periods...
September 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28835439/management-of-rivaroxaban-or-apixaban-associated-major-bleeding-with-prothrombin-complex-concentrates-a-cohort-study
#9
Ammar Majeed, Anna Ågren, Margareta Holmström, Maria Bruzelius, Roza Chaireti, Jacob Odeberg, Eva-Lotta Hempel, Maria Magnusson, Tony Frisk, Sam Schulman
There is uncertainty regarding the effectiveness and occurrence of thromboembolic events in patients treated with prothrombin complex concentrates (PCC) for management of major bleeding events (MBE) on rivaroxaban or apixaban. We investigated the effectiveness of PCC given for management of MBE on rivaroxaban or apixaban. Between 1/1/2014 and 1/10/2016, we prospectively included patients treated with PCC for management of MBE on rivaroxaban or apixaban. The effectiveness of PCC was assessed using the International Society of Thrombosis and Hemostasis' Scientific and Standardization Subcommittee criteria for the assessment of effectiveness of major bleeding management...
August 23, 2017: Blood
https://www.readbyqxmd.com/read/28833357/prothrombin-complex-concentrate-reduces-blood-product-utilization-in-heart-transplantation
#10
Daniel H Enter, Anthony L Zaki, Megan Marsh, Nikki Cool, Jane Kruse, Zhi Li, Adin-Cristian Andrei, Adam Iddriss, Patrick M McCarthy, S Chris Malaisrie, Allen Anderson, Jonathan D Rich, Duc Thinh Pham
BACKGROUND: Current practices for the reversal of warfarin prior to cardiac surgery include the use of vitamin K and fresh frozen plasma (FFP) to reduce the risk of bleeding. Although the 2010 International Society of Heart and Lung Transplantation guidelines acknowledge the use of PCC (Prothrombin Complex Concentrate), there is no clear consensus on its efficacy. The objective of this study was to assess the efficacy of 4-factor Prothrombin Complex Concentrate (4-F PCC) administration in patients requiring warfarin reversal prior to heart transplantation by determining blood product utilization perioperatively...
August 22, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28815410/efficacy-and-safety-of-a-4-factor-prothrombin-complex-concentrate-for-rapid-vitamin-k-antagonist-reversal-in-japanese-patients-presenting-with-major-bleeding-or-requiring-urgent-surgical-or-invasive-procedures-a-prospective-open-label-single-arm-phase-3b-study
#11
Shigeki Kushimoto, Toshio Fukuoka, Akio Kimura, Kazunori Toyoda, Andres Brainsky, Amy Harman, Thomas Chung, Masahiro Yasaka
Rapid vitamin K antagonist (VKA) reversal is required in patients experiencing major bleeding or requiring urgent surgery. Four-factor prothrombin complex concentrate (4F-PCC; Beriplex(®)/Kcentra(®)) was shown in two large randomized controlled, international phase 3b trials to be an effective alternative to plasma for urgent VKA reversal. In the present prospective, open-label, single-arm phase 3b trial, we evaluate the efficacy and safety of 4F-PCC in Japanese patients. Eleven patients [international normalized ratio (INR) ≥2] requiring rapid VKA reversal owing to major bleeding (n = 6) or before urgent surgical/invasive procedures (n = 5) were administered 4F-PCC dosed based on INR and weight...
August 16, 2017: International Journal of Hematology
https://www.readbyqxmd.com/read/28803708/anti-phospholipid-syndrome-current-opinion-on-mechanisms-involved-laboratory-characterization-and-diagnostic-aspects
#12
REVIEW
Jean Amiral, Marie Peyrafitte, Claire Dunois, Anne Marie Vissac, Jerard Seghatchian
Anti-phospholipid syndrome is a complex and severe clinical situation, associated with symptoms such as recurrent thrombosis, arterial or venous, at any site, pregnancy loss, and other related syndromes. These clinical burdens, are highly variable from patient to patient, and are associated with biological abnormalities, such as the presence of the Lupus Anticoagulant or phospholipid dependent antibodies, confirmed on two occasions at least 12 weeks apart. From the diagnosis standpoint, both, functional (clotting) or immunological assays, are difficult to standardize and to optimize, due to the absence of reference material, or a characteristic clinical group, and international reference preparations...
July 15, 2017: Transfusion and Apheresis Science
https://www.readbyqxmd.com/read/28796276/colistin-dampens-fibrinolysis-and-endothelial-activation-during-endotoxaemia-a-randomised-double-blind-trial
#13
Christian Schoergenhofer, Peter Matzneller, Marion Mußbacher, Johannes A Schmid, Petra Jilma-Stohlawetz, Markus Zeitlinger, Bernd Jilma
Colistin electrostatically interacts with lipopolysaccharides (LPS). Pre-clinical studies demonstrated beneficial effects of colistin on LPS-induced coagulation and fibrinolysis. The objective of this trial was to investigate the effects of colistin during experimental endotoxaemia. In this randomised, double-blind, placebo-controlled, crossover trial 16 healthy volunteers received a 2 ng/kg LPS bolus after infusion of 2.5 million IU colistin or placebo. Plasma levels of F1+2 prothrombin fragments, thrombin-antithrombin complexes (TAT), von Willebrand factor antigen levels (vWF), E-selectin, plasmin-antiplasmin complexes (PAP), tissue-type plasminogen activator (t-PA) antigen and activity, plasminogen activator inhibitor-1 (PAI-1) were measured...
August 30, 2017: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/28789610/management-of-refractory-bleeding-post-cardiopulmonary-bypass-in-an-acute-heparin-induced-thrombocytopenia-type-ii-renal-failure-patient-who-underwent-urgent-cardiac-surgery-with-bivalirudin-angiox-%C3%A2-anticoagulation
#14
Kimberly Hassen, Maria R Maccaroni, Haytham Sabry, Smitangshu Mukherjee, Shankari Serumadar, Inderpaul Birdi
Acute heparin-induced thrombocytopenia (HIT) patients present a myriad of anticoagulation management challenges, in clinical settings where unfractionated heparin (UFH) is the traditional drug of choice. UFH use in cardiac surgery is a known entity that has been subject to rigorous research. Research has, thus, led to its unparalleled use and the development of well-established protocols for cardiac surgery. In comparison to UFH, bivalirudin use for acute HIT patients requiring urgent cardiac surgery with cardiopulmonary bypass (CPB) is still in its infancy...
August 1, 2017: Perfusion
https://www.readbyqxmd.com/read/28769570/reversal-of-direct-oral-anticoagulants
#15
REVIEW
Mosaad Almegren
Reversal agents for direct oral anticoagulants (DOACs), including factor X inhibitors and direct thrombin inhibitors, are a major concern in clinical practice. After DOACs were introduced and became widely used as an alternative for vitamin K antagonists in the management of venous thromboembolism and nonvalvular atrial fibrillation, the need for effective reversal agents has increased, particularly for life-threatening bleeding episodes related to DOACs or to reverse medication effects during urgent interventions...
2017: Vascular Health and Risk Management
https://www.readbyqxmd.com/read/28765353/hemostatic-management-of-trauma-induced-coagulopathy
#16
Janise B Phillips, Phillip L Mohorn, Rebecca E Bookstaver, Tanya O Ezekiel, Christopher M Watson
Trauma-induced coagulopathy is a primary factor in many trauma-related fatalities. Management hinges upon rapid diagnosis of coagulation abnormalities and immediate administration of appropriate hemostatic agents. Use of crystalloids and packed red blood cells has traditionally been the core of trauma resuscitation, but current massive transfusion protocols include combination therapy with fresh frozen plasma and predefined ratios of platelets to packed red blood cells, limiting crystalloid administration. Hemostatic agents such as tranexamic acid, prothrombin complex concentrate, fibrinogen concentrate, and, in cases of refractory bleeding, recombinant activated factor VIIa may also be warranted...
August 2017: Critical Care Nurse
https://www.readbyqxmd.com/read/28763307/comparison-of-3-factor-versus-4-factor-prothrombin-complex-concentrate-with-regard-to-warfarin-reversal-blood-product-use-and-costs
#17
Jessica DeAngelo, Daniel Jarrell, Richard Cosgrove, James Camamo, Christopher Edwards, Asad E Patanwala
BACKGROUND: Prothrombin complex concentrates (PCCs) are drug products containing varying amounts of vitamin K-dependent coagulation factors II, VII, IX, and X. The evidence comparing 3-factor PCC (3-PCC) versus 4-factor PCC (4-PCC) for warfarin reversal is conflicting. It has been hypothesized that 3-PCC may be less effective than 4-PCC because of relatively lower factor VII content. STUDY QUESTION: The primary objective of this study was to compare international normalized ratio (INR) reversal between 3-PCC and 4-factor PCC (4-PCC) in warfarin-treated patients...
July 26, 2017: American Journal of Therapeutics
https://www.readbyqxmd.com/read/28724836/prothrombin-complex-concentrate-for-vitamin-k-antagonist-associated-intracranial-hemorrhage%C3%A3-global-evidence-and-the-japanese-perspective
#18
Masahiro Yasaka, Andres Brainsky, Kazunori Toyoda
Patients receiving vitamin K antagonists (VKAs) are at increased risk of bleeding. Intracranial hemorrhage (ICH) is a major cause of morbidity and mortality in this population, and is a particular concern among Japanese clinicians, given reports of an elevated risk of this bleeding type in patients of Asian ethnicity. Patients with VKA-associated ICH require rapid international normalized ratio (INR) reversal, and treatment guidelines suggest the use of prothrombin complex concentrates (PCCs) or plasma for this purpose...
July 19, 2017: Circulation Journal: Official Journal of the Japanese Circulation Society
https://www.readbyqxmd.com/read/28700408/three-versus-four-factor-prothrombin-complex-concentrates-for-factor-based-resuscitation-in-a-porcine-hemorrhagic-shock-model
#19
Donald Michael Moe, Michael Scott Lallemand, John Mason McClellan, Joshua Porter Smith, Shannon T Marko, Matthew J Eckert, Matthew J Martin
BACKGROUND: Bleeding is a leading cause of preventable death following severe injury. Prothrombin complex concentrates (PCC) treat inborn coagulation disorders and reverse oral anticoagulants, but are proposed for use in "factor-based" resuscitation strategies. Few studies exist for this indication in acidosis, or that compare 3-factor (3PCC) versus 4-factor (4PCC) products. We aimed to assess and compare their safety and efficacy in a porcine model of severe hemorrhagic shock and coagulopathy...
July 12, 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28691557/emicizumab-prophylaxis-in-hemophilia-a-with-inhibitors
#20
RANDOMIZED CONTROLLED TRIAL
Johannes Oldenburg, Johnny N Mahlangu, Benjamin Kim, Christophe Schmitt, Michael U Callaghan, Guy Young, Elena Santagostino, Rebecca Kruse-Jarres, Claude Negrier, Craig Kessler, Nancy Valente, Elina Asikanius, Gallia G Levy, Jerzy Windyga, Midori Shima
BACKGROUND: Emicizumab (ACE910) bridges activated factor IX and factor X to restore the function of activated factor VIII, which is deficient in persons with hemophilia A. This phase 3, multicenter trial assessed once-weekly subcutaneous emicizumab prophylaxis in persons with hemophilia A with factor VIII inhibitors. METHODS: We enrolled participants who were 12 years of age or older. Those who had previously received episodic treatment with bypassing agents were randomly assigned in a 2:1 ratio to emicizumab prophylaxis (group A) or no prophylaxis (group B)...
August 31, 2017: New England Journal of Medicine
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