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Beriplex

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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
#1
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/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
#2
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/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
#3
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/28191640/pathogen-safety-of-a-pasteurized-four-factor-human-prothrombin-complex-concentrate-preparation-using-serial-20n-virus-filtration
#4
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
https://www.readbyqxmd.com/read/27553841/recombinant-factor-viia-mediated-activation-of-prothrombin-complex-concentrates
#5
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...
April 2017: Clinical and Applied Thrombosis/hemostasis
https://www.readbyqxmd.com/read/26822172/safety-of-a-four-factor-prothrombin-complex-concentrate-versus-plasma-for-vitamin-k-antagonist-reversal-an-integrated-analysis-of-two-phase-iiib-clinical-trials
#6
RANDOMIZED CONTROLLED TRIAL
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
https://www.readbyqxmd.com/read/26447393/four-factor-prothrombin-complex-concentrate-reverses-apixaban-associated-bleeding-in-a-rabbit-model-of-acute-hemorrhage
#7
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
https://www.readbyqxmd.com/read/26135740/increased-risk-of-volume-overload-with-plasma-compared-with-four-factor-prothrombin-complex-concentrate-for-urgent-vitamin-k-antagonist-reversal
#8
RANDOMIZED CONTROLLED TRIAL
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
https://www.readbyqxmd.com/read/26094105/thromboembolic-events-after-vitamin-k-antagonist-reversal-with-4-factor-prothrombin-complex-concentrate-exploratory-analyses-of-two-randomized-plasma-controlled-studies
#9
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
https://www.readbyqxmd.com/read/25728933/four-factor-prothrombin-complex-concentrate-versus-plasma-for-rapid-vitamin-k-antagonist-reversal-in-patients-needing-urgent-surgical-or-invasive-interventions-a-phase-3b-open-label-non-inferiority-randomised-trial
#10
RANDOMIZED CONTROLLED TRIAL
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
https://www.readbyqxmd.com/read/25688458/prevention-of-bleeding-and-hemorrhagic-complications-in-surgical-patients-with-inherited-factor-vii-deficiency
#11
Adam Wiszniewski, Andrzej Szczepanik, Andrzej Misiak, Ksenia Bykowska, Piotr Szopiński
Inherited factor VII (FVII) deficiency is a rare autosomal recessive hemorrhagic disorder. The major clinical symptoms include: bleeding from the oral cavity, epistaxis, menorrhagia, spontaneous hemarthros, bleeding to the gastrointestinal tract and central nervous system, and perioperative bleeding. The aim of this study was to present our experience in preventing bleeding and hemorrhagic disorders in surgical patients with inherited FVII deficiency by using recombinant activated FVIIa (rFVIIa), and with prothrombin complex concentrates (PCCs)...
April 2015: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
https://www.readbyqxmd.com/read/25619440/correlation-of-coagulation-markers-and-4f-pcc-mediated-reversal-of-rivaroxaban-in-a-rabbit-model-of-acute-bleeding
#12
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
https://www.readbyqxmd.com/read/25419685/effective-reversal-of-edoxaban-associated-bleeding-with-four-factor-prothrombin-complex-concentrate-in-a-rabbit-model-of-acute-hemorrhage
#13
Eva Herzog, Franz Kaspereit, Wilfried Krege, Baerbel Doerr, Jochen Mueller-Cohrs, Ingo Pragst, Yoshiyuki Morishima, Gerhard Dickneite
BACKGROUND: Edoxaban is an oral, selective direct factor Xa inhibitor approved in Japan for venous thromboembolism prevention after orthopedic surgery. Data are lacking regarding reversal strategies for edoxaban; this study assessed whether four-factor prothrombin complex concentrate (Beriplex/Kcentra; CSL Behring GmbH, Marburg, Germany) can effectively reverse its effects on hemostasis using a previously described rabbit model. METHODS: The study comprised assessments of thrombin generation in vitro, pharmacokinetic parameters, and edoxaban reversal in vivo...
February 2015: Anesthesiology
https://www.readbyqxmd.com/read/25282184/prothrombin-complex-concentrate-beriplex-p-n-related-renal-and-cerebral-infarctions-in-a-patient-with-warfarin-associated-intracerebral-hemorrhage
#14
Shin-Yi Lin, Sun-Chun Tang, Li-Jiuan Shen, Jiann-Shing Jeng
A 45-year-old man receiving warfarin treatment suffered from an intracerebral hemorrhage. Four-factor prothrombin complex concentrate (PCC) was administered to correct coagulopathy. However, bilateral renal infarcts and a cerebral infarct developed on day 5 and 7, respectively after PCC administration. Although the occurrence of PCC-related thromboembolism is low, health care practitioners should closely follow-up the symptoms and signs of thrombosis after PCC administration.
January 2015: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
https://www.readbyqxmd.com/read/25168947/prothrombin-complex-concentrates-as-reversal-agents-for-new-oral-anticoagulants-lessons-from-preclinical-studies-with-beriplex
#15
REVIEW
Gerhard Dickneite
Although new oral anticoagulants (NOACs) represent an advance in anticoagulant therapy over vitamin K antagonists (VKAs), they nevertheless have a low, but significant risk for bleeding complications. Reversal agents for VKAs, such as prothrombin complex concentrates (PCCs), are currently being evaluated in preclinical studies for NOAC reversal. This article reviews the preclinical data for the most extensively studied PCC for NOAC reversal, Beriplex, a 4-factor PCC. The results from the Beriplex studies are also compared with those obtained with other reversal agents, including different nonactivated PCCs, activated PCCs, and recombinant activated factor VII...
September 2014: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/25084749/thrombotic-safety-of-prothrombin-complex-concentrate-beriplex-p-n-for-dabigatran-reversal-in-a-rabbit-model
#16
Eva Herzog, Franz J Kaspereit, Wilfried Krege, Baerbel Doerr, Joanne van Ryn, Gerhard Dickneite, Ingo Pragst
INTRODUCTION: In vivo animal data have shown prothrombin complex concentrate (PCC) to be effective in preventing bleeding induced by excessive plasma levels of the direct thrombin inhibitor dabigatran. This animal model study was designed to determine the risk of thrombosis associated with administration of a PCC (Beriplex P/N) to reverse dabigatran-induced bleeding. MATERIALS AND METHODS: Anesthetized rabbits were treated with initial 0, 75, 200 or 450 μg kg(-1) dabigatran boluses followed by continuous infusions to maintain elevated plasma dabigatran levels...
September 2014: Thrombosis Research
https://www.readbyqxmd.com/read/24811969/comparison-of-three-factor-and-four-factor-prothrombin-complex-concentrates-regarding-reversal-of-the-anticoagulant-effects-of-rivaroxaban-in-healthy-volunteers
#17
RANDOMIZED CONTROLLED TRIAL
M Levi, K T Moore, C F Castillejos, D Kubitza, S D Berkowitz, S Z Goldhaber, M Raghoebar, M R Patel, J I Weitz, J H Levy
BACKGROUND: Four-factor prothrombin complex concentrates (PCCs), which contain factor II, FVII, FIX, and FX, have shown the potential to reverse the anticoagulant effect of rivaroxaban in healthy volunteers. The purpose of this study was to determine whether a three-factor PCC, which contains little FVII, has a similar effect. METHODS AND RESULTS: We performed an open-label, single-center, parallel-group study comparing the effect of a three-factor PCC (Profilnine SD) with that of a four-factor PCC (Beriplex P/N) on the pharmacodynamics of rivaroxaban in 35 healthy volunteers...
September 2014: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/24714118/reversal-of-dabigatran-induced-bleeding-by-coagulation-factor-concentrates-in-a-rat-tail-bleeding-model-and-lack-of-effect-on-assays-of-coagulation
#18
Joanne van Ryn, Johanna Schurer, Monika Kink-Eiband, Andreas Clemens
BACKGROUND: Dabigatran is a potent oral anticoagulant. Like any anticoagulant, there is an increased risk of bleeding associated with its use, and reversal may be needed in cases of severe bleeding. METHODS: In this study, six coagulation factor concentrates (CFCs) were tested for their ability to reduce bleeding induced by oral dabigatran etexilate (30 mg/kg) in a rat-tail bleeding model (n = 5 to 8 per group): three-factor (Profilnine [Grifols Biologicals Inc...
June 2014: Anesthesiology
https://www.readbyqxmd.com/read/23636219/reversal-of-rivaroxaban-anticoagulation-by-haemostatic-agents-in-rats-and-primates
#19
Elisabeth Perzborn, András Gruber, Hanna Tinel, Ulla M Marzec, Ulf Buetehorn, Anja Buchmueller, Stefan Heitmeier, Volker Laux
Rivaroxaban is an oral, direct factor Xa inhibitor for the management of thromboembolic disorders. Despite its short half-life, the ability to reverse rivaroxaban anticoagulation could be beneficial in life-threatening emergencies. The potential of prothrombin complex concentrate (PCC; Beriplex®), activated PCC (aPCC; FEIBA®) or recombinant activated factor VII (rFVIIa; NovoSeven®) to reverse rivaroxaban in rats and baboons was investigated. Anaesthetised rats pre-treated with intravenous rivaroxaban (2 mg/kg) received intravenous rFVIIa (100/400 μg/kg), PCC (25/50 U/kg) or aPCC (50/100 U/kg) after initiation of bleeding...
July 2013: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/23335567/long-term-safety-and-efficacy-of-a-pasteurized-nanofiltrated-prothrombin-complex-concentrate-beriplex-p-n-a-pharmacovigilance-study
#20
REVIEW
A A Hanke, C Joch, K Görlinger
BACKGROUND: The rapid reversal of the effects of vitamin K antagonists is often required in cases of emergency surgery and life-threatening bleeding, or during bleeding associated with high morbidity and mortality such as intracranial haemorrhage. Increasingly, four-factor prothrombin complex concentrates (PCCs) containing high and well-balanced concentrations of vitamin K-dependent coagulation factors are recommended for emergency oral anticoagulation reversal. Both the safety and efficacy of such products are currently in focus, and their administration is now expanding into the critical care setting for the treatment of life-threatening bleeding and coagulopathy resulting either perioperatively or in cases of acute trauma...
May 2013: British Journal of Anaesthesia
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