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Thomas Nowak, Birgit Popp, Albrecht Gröner, Wolfram Schäfer, Uwe Kalina, Karlheinz Enssle, Nathan J Roth
BACKGROUND: Beriplex P/N/Kcentra/Coaplex/Confidex is a four-factor human prothrombin complex concentrate (PCC). Here, we describe the pathogen safety profile and biochemical characteristics of an improved manufacturing process that further enhances the virus safety of Beriplex P/N. STUDY DESIGN AND METHODS: Samples of product intermediates were spiked with test viruses, and prions were evaluated under routine production and robustness conditions of the scale-down version of the commercial manufacturing process for their capacity to inactivate or remove pathogens...
May 2017: Transfusion
Maura K Wychowski, Christina I Ruscio, Peter A Kouides, Ronald L Sham
To report the impact of an inpatient anticoagulation stewardship program at a community hospital to promote optimal anticoagulant use. The anticoagulation team (ACT) stewardship program consists of two clinical pharmacists and hematologists to provide oversight of anticoagulants, high cost reversal agents including prothrombin complex concentrate (PCC, Kcentra™), and heparin-induced thrombocytopenia (HIT) management. Intervention data and number of charts reviewed were collected. Average cost avoidance data was applied to ACT interventions to estimate cost savings...
April 2017: Journal of Thrombosis and Thrombolysis
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...
January 1, 2016: Clinical and Applied Thrombosis/hemostasis
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...
August 25, 2016: Annals of Transplantation: Quarterly of the Polish Transplantation Society
Prateek Agarwal, Ashwin G Ramayya, Kalil G Abdullah, Nikhil Nayak, Timothy H Lucas
INTRODUCTION: Reversal of anticoagulation is required to mitigate the risk of intracranial bleeding before urgent neurosurgical procedures. New pharmacological agents, such as multifactor prothrombin complex concentrate (PCC; Kcentra), promise rapid efficacy but may raise the probability of thrombotic complications above vitamin K infusion or administration of fresh frozen plasma (FFP). In this study, we examined the rate of thrombotic complications in neurosurgical patients who received either PCC or FFP and Vitamin K before undergoing urgent surgery...
August 2016: Neurosurgery
S Nagalla, L Thomson, Y Oppong, B Bachman, I Chervoneva, W K Kraft
It was hypothesized that the four-factor prothrombin complex concentrate (4F-PCC) Kcentra 25 unit/kg would reverse impairment of thrombin generation in healthy volunteers dosed with apixaban to steady state. In this randomized, two-period crossover, assessor-blinded trial, 12 healthy subjects received 5 mg apixaban every 12 h. Three h after the fifth dose, four-factor prothrombin complex concentrate (4F-PCC) 25 unit/kg or saline were infused. Serial blood samples were assessed for thrombin generation using PPP-reagent and PPP-reagent low, anti-Xa, PT, and PTT assays...
June 2016: Clinical and Translational Science
David T Martin, Cassie A Barton, Christopher Dodgion, Martin Schreiber
BACKGROUND: Reversal of warfarin-induced coagulopathy after traumatic injury may be done exclusively with prothrombin complex concentrates (PCCs). No direct comparisons between different PCC regimens exist to guide clinical decision-making. Our institution has used 2 distinct PCC strategies for warfarin reversal; a 3-Factor PCC (Profilnine) combined with activated Factor VII (3F-PCC+rVIIa), and a 4-Factor PCC (Kcentra) given without additional factor supplementation. METHODS: Retrospective review of all PCC administrations to trauma patients with acute bleeding who were taking warfarin before injury...
May 2016: American Journal of Surgery
Truman J Milling, Majed A Refaai, Ravi Sarode, Brandon Lewis, Antoinette Mangione, Billie L Durn, Amy Harman, Martin L Lee, Joshua N Goldstein
OBJECTIVES: Clinicians often need to rapidly reverse vitamin K antagonists (VKAs) in the setting of major hemorrhage or urgent need for surgery. Little is known about the safety profile of the traditional reversal agent, plasma, or the newly approved agent, four-factor prothrombin complex concentrate (4F-PCC), in a randomized setting. This is an integrated analysis of safety data from two clinical trials that evaluated 4F-PCC versus plasma for the treatment of patients requiring rapid VKA reversal for acute major bleeding or prior to an urgent surgical/invasive procedure...
April 2016: Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine
Shibani Pati, Daniel R Potter, Gyulnar Baimukanova, David H Farrel, John B Holcomb, Martin A Schreiber
BACKGROUND: Transfusion of balanced ratios of plasma to platelets and red blood cells has been shown to reduce early death from exsanguination in trauma patients. Aside from hemostasis, recent work has shown that plasma reduces vascular endothelial permeability, inflammation, and organ edema after hemorrhagic shock (HS), all components of the endotheliopathy of trauma. We hypothesized that Kcentra could have protective effects on the endotheliopathy of trauma comparable with fresh frozen plasma (FFP)...
April 2016: Journal of Trauma and Acute Care Surgery
Ashley Hedges, James C Coons, Melissa Saul, Roy E Smith
Prothrombin complex concentrates (PCCs) are indicated for urgent reversal of warfarin and used for reversal of novel oral anticoagulants, in patients with acute major bleeding or need for an urgent procedure. The research goal was to evaluate effectiveness and safety outcomes with PCC usage at our institution. A retrospective review of electronic medical records identified patients that received a PCC commercially available in the United States (KCentra(®) or Profilnine(®)) at twelve hospitals in a tertiary care health system from July 1, 2013 to April 30, 2014...
July 2016: Journal of Thrombosis and Thrombolysis
Sarah W Franklin, Fania Szlam, Janet D Fernandez, Traci Leong, Kenichi A Tanaka, Nina A Guzzetta
BACKGROUND: Bleeding is a serious complication after pediatric cardiopulmonary bypass (CPB) that is associated with an increase in perioperative morbidity and mortality. Four-factor prothrombin complex concentrates (4F-PCCs) have been used off-label to supplement transfusion protocols for bleeding after CPB in adults; however, data on their use in neonates are limited. In this study, we hypothesized that 4F-PCCs administered ex vivo to neonatal plasma after CPB will increase thrombin generation...
April 2016: Anesthesia and Analgesia
Rachel Stratman, Emily Owen, Gabrielle Gibson, Theresa Human
No abstract text is available yet for this article.
December 2015: Critical Care Medicine
Gabrielle Gibson, Emily Owen, Theresa Human, Rachel Stratman
No abstract text is available yet for this article.
December 2015: Critical Care Medicine
Emily Owen, Theresa Human, Gabrielle Gibson, Rachel Stratman
No abstract text is available yet for this article.
December 2015: Critical Care Medicine
Allison E Berndtson, Wan-Ting Huang, Kevin Box, Leslie Kobayashi, Laura N Godat, Alan M Smith, David Weingarten, Raul Coimbra
BACKGROUND: As the population ages, more trauma patients are admitted with coagulopathy. Fresh frozen plasma is effective in reversing coagulopathy caused by warfarin; however, it is not appropriate for all patients. Prothrombin complex concentrates (PCCs) are an alternative for patients who require emergent reversal, minimal-volume administration and who have a supratherapeutic international normalized ratio (INR). A four-factor PCC initially approved in Europe is now available in the United States...
December 2015: Journal of Trauma and Acute Care Surgery
E Herzog, F Kaspereit, W Krege, J Mueller-Cohrs, B Doerr, P Niebl, G Dickneite
BACKGROUND: Apixaban is a direct factor Xa inhibitor approved for the treatment and prevention of thromboembolic disease. There is a lack of data regarding its reversal in cases of acute bleeding or prior to emergency surgery that needs addressing. OBJECTIVES: This study assessed whether a four-factor prothrombin complex concentrate (4F-PCC; Beriplex(®) /Kcentra(®) , CSL Behring) can effectively reverse apixaban-associated bleeding in an in vivo rabbit model and evaluated the correlations between in vivo hemostasis and in vitro coagulation parameters...
December 2015: Journal of Thrombosis and Haemostasis: JTH
Majed A Refaai, Joshua N Goldstein, Martin L Lee, Billie L Durn, Truman J Milling, Ravi Sarode
BACKGROUND: Plasma is commonly used for vitamin K antagonist (VKA) reversal, but observational studies suggest that it is associated with transfusion-related adverse reactions (e.g., volume overload). However, this issue has not previously been addressed in a randomized controlled trial (RCT). STUDY DESIGN AND METHODS: Factors associated with volume overload were examined using data from two Phase IIIb RCTs comparing plasma with four-factor prothrombin complex concentrate (4F-PCC, Beriplex/Kcentra, CSL Behring) for urgent VKA reversal...
November 2015: Transfusion
Truman J Milling, Majed A Refaai, Joshua N Goldstein, Astrid Schneider, Laurel Omert, Amy Harman, Martin L Lee, Ravi Sarode
STUDY OBJECTIVE: We evaluated thromboembolic events after vitamin K antagonist reversal in post hoc analyses of pooled data from 2 randomized trials comparing 4-factor prothrombin complex concentrate (4F-PCC) (Beriplex/Kcentra) with plasma. METHODS: Unblinded investigators identified thromboembolic events, using standardized terms (such as "myocardial infarction," "deep vein thrombosis," "pulmonary embolism," and "ischemic stroke"). A blinded safety adjudication board reviewed serious thromboembolic events, as well as those referred by an independent unblinded data and safety monitoring board...
January 2016: Annals of Emergency Medicine
Joshua N Goldstein, Majed A Refaai, Truman J Milling, Brandon Lewis, Robert Goldberg-Alberts, Bruce A Hug, Ravi Sarode
BACKGROUND: Rapid reversal of vitamin K antagonist (VKA)-induced anticoagulation is often necessary for patients needing urgent surgical or invasive procedures. The optimum means of VKA reversal has not been established in comparative clinical trials. We compared the efficacy and safety of four-factor prothrombin complex concentrate (4F-PCC) with that of plasma in VKA-treated patients needing urgent surgical or invasive procedures. METHODS: In a multicentre, open-label, phase 3b randomised trial we enrolled patients aged 18 years or older needing rapid VKA reversal before an urgent surgical or invasive procedure...
May 23, 2015: Lancet
Eva Herzog, Franz Kaspereit, Wilfried Krege, Jochen Mueller-Cohrs, Baerbel Doerr, Peter Niebl, Gerhard Dickneite
INTRODUCTION: Rivaroxaban is an oral, selective direct factor Xa inhibitor approved for several indications in patients at risk of thrombotic events. One limitation of its clinical use is the lack of data pertaining to its reversal in situations where urgent response is critical (e.g. acute bleeding events or emergency surgery). MATERIALS AND METHODS: This study assessed the effectiveness of a four-factor prothrombin complex concentrate (4F-PCC; Beriplex(®)/Kcentra(®)) for the reversal of rivaroxaban-associated bleeding in an in vivo rabbit model, and evaluated the correlations between in vitro coagulation parameters and haemostasis in vivo...
March 2015: Thrombosis Research
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