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4F PCC

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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
#1
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/28660341/low-dose-prothrombin-complex-concentrate-for-warfarin-associated-intracranial-hemorrhage-with-inr-less-than-2-0
#2
Wesley R Zemrak, Kathryn E Smith, Stephen S Rolfe, Teresa May, Robert L Trowbridge, Timothy L Hayes, Gene A Grindlinger, David B Seder
BACKGROUND: Prothrombin complex concentrates (PCCs) have become the first-line therapy for warfarin reversal in the setting of central nervous system (CNS) hemorrhage. Randomized, controlled studies comparing agents for warfarin reversal excluded patients with international normalized ratio (INR) <2, yet INR values of 1.6-1.9 are also associated with poor outcomes. METHODS: We retrospectively reviewed our use of a low-dose (15 units/kg) strategy of 4-factor PCC (4F-PCC) on warfarin reversal (INR 1...
June 28, 2017: Neurocritical Care
https://www.readbyqxmd.com/read/28604569/use-of-four-factor-prothrombin-complex-concentrate-in-the-reversal-of-warfarin-induced-and-nonvitamin-k-antagonist-related-coagulopathy
#3
Hannah Young, Jeremy L Holzmacher, Richard Amdur, Stephen Gondek, Babak Sarani, Mary E Schroeder
: To evaluate the efficacy of international normalized ratio (INR) reversal using four-factor prothrombin complex concentrate (4F-PCC) in nonmedication-induced coagulopathy. We performed a single-site, retrospective cohort study of patients receiving off-label use of 4F-PCC. Cohorts included liver dysfunction if they had acute liver decompensation or cirrhosis without other causative factors of liver failure such as sepsis, coagulopathy of acute sepsis (CAS) if they had documentation of sepsis and no underlying liver disorder, known factor deficiencies, or medication-induced coagulopathy, or warfarin if they were taking warfarin...
June 9, 2017: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
https://www.readbyqxmd.com/read/28469866/use-of-four-factor-prothrombin-complex-concentrate-for-the-mitigation-of-rivaroxaban-induced-bleeding-in-an-emergent-coronary-artery-bypass-graft
#4
Michael Liu, Cliff Aguele, Umer Darr
We presented the first case of four-factor prothrombin complex concentrate (4F-PCC) for the alleviation of bleeding for emergent on-pump coronary artery bypass graft (CABG) with the patient discharged by postoperative day (POD) 9 with no sequelae. Until direct antidotes are available, 4F-PCC may play a role in the management of mitigating rivaroxaban-induced bleeding in surgical procedure.
May 2017: Clinical Case Reports
https://www.readbyqxmd.com/read/28161220/comparison-of-the-safety-and-efficacy-between-3-factor-and-4-factor-prothrombin-complex-concentrates-for-the-reversal-of-warfarin
#5
COMPARATIVE STUDY
Julia E Kuroski, Sarah Young
PURPOSE: Prior to the Food and Drug Administration approval of 4-factor prothrombin complex concentrate (4F-PCC), only 3-factor PCC (3F-PCC) products were available in the US. There is limited data comparing the safety and efficacy of 3F-PCC versus 4F-PCC. The purpose of our study, therefore, was to compare the safety and efficacy profiles of 3F-PCC versus 4F-PCC for the emergent reversal of warfarin. METHODS: A single-center, retrospective cohort analysis compared patients who received 3F-PCC or 4F-PCC for the emergent reversal of warfarin due to life-threating bleeding from January 2013 to September 2015...
June 2017: American Journal of Emergency Medicine
https://www.readbyqxmd.com/read/27851164/1528-4f-pcc-demonstrates-favorable-efficacy-in-a-rabbit-model-of-coagulopathy-and-acute-bleeding
#6
Eva Herzog, Franz Kaspereit, Wilfried Krege, Baerbel Doerr, Marcel Mischnik, Ingo Pragst, Gerhard Dickneite
No abstract text is available yet for this article.
December 2016: Critical Care Medicine
https://www.readbyqxmd.com/read/27851140/1504-4f-pcc-demonstrates-favorable-safety-profile-in-a-rabbit-model-of-venous-thrombosis
#7
Eva Herzog, Franz Kaspereit, Wilfried Krege, Baerbel Doerr, Marcel Mischnik, Ingo Pragst, Gerhard Dickneite
No abstract text is available yet for this article.
December 2016: Critical Care Medicine
https://www.readbyqxmd.com/read/27850536/898-evaluation-of-the-impact-of-weight-estimations-on-anticoagulation-reversal-with-4f-pcc-in-the-ed
#8
Jennifer Vidal, Gabrielle Procopio, Michelle Hines, Steven Nerenberg, Amit Gupta, Brian Faley
No abstract text is available yet for this article.
December 2016: Critical Care Medicine
https://www.readbyqxmd.com/read/27850261/622-4f-pcc-for-reversal-of-direct-acting-oral-anticoagulants-for-major-bleeds-or-emergent-surgery
#9
Karen Berger, Lina Lin, Christine Lesch
No abstract text is available yet for this article.
December 2016: Critical Care Medicine
https://www.readbyqxmd.com/read/27789547/reversal-of-anticoagulation-with-four-factor-prothrombin-complex-concentrate-without-concurrent-vitamin-k-phytonadione-for-urgent-surgery-in-a-patient-at-moderate-to-high-risk-for-thromboembolism
#10
Thomas Michael Farley, Elisha M Andreas
Successful vitamin K antagonist (eg, warfarin) reversal with 4-factor prothrombin complex concentrate (4F-PCC) without vitamin K (phytonadione) for emergent surgery in a patient at moderate-to-high risk for thromboembolism is reported. This approach may decrease the risk for development of thrombus, as it limits the amount of time the patient's anticoagulation is subtherapeutic. It also may increase the risk of bleeding, so patient selection is essential if this strategy is employed. Caution must be exercised to complete the procedure or surgery in the window of peak 4F-PCC effect (∼1-6 hours postinfusion)...
October 27, 2016: BMJ Case Reports
https://www.readbyqxmd.com/read/27628534/four-factor-prothrombin-complex-concentrate-for-coagulopathy-reversal-in-patients-with-liver-disease
#11
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
https://www.readbyqxmd.com/read/27546767/four-factor-prothrombin-complex-concentrate-for-life-threatening-bleeds-or-emergent-surgery-a-retrospective-evaluation
#12
Jonathan H Sin, Karen Berger, Christine A Lesch
PURPOSE: Previous trials investigating usage of four-factor prothrombin complex concentrate (4F-PCC) excluded patients with various thrombotic risk factors. The objective of this study was to evaluate the safety and effectiveness of 4F-PCC in a real-world setting based on an institutional protocol that does not have strict exclusion criteria. METHODS: This was a retrospective study of adult patients who received 4F-PCC. The primary outcome was a confirmed thromboembolism within 14 days after 4F-PCC administration...
December 2016: Journal of Critical Care
https://www.readbyqxmd.com/read/27378481/successful-use-of-four-factor-prothrombin-complex-concentrate-for-congenital-factor-x-deficiency-in-the-setting-of-neurosurgery
#13
Alexa J Siddon, Christopher A Tormey
Congenital factor X deficiency is an extremely rare coagulation disorder that can place patients at risk for spontaneous hemorrhage or excessive bleeding in the setting of trauma or invasive procedures. Given the rarity of this disorder, there is little published guidance on how best to prevent or treat bleeding. Herein, we report a case of a 56-year-old white man with congenital factor X deficiency who was scheduled for major neurosurgery and who was treated perioperatively with 4-factor prothrombin complex concentrate (4F-PCC)...
August 2016: Laboratory Medicine
https://www.readbyqxmd.com/read/27347708/anticoagulation-reversal-strategies-for-left-ventricular-assist-device-patients-presenting-with-acute-intracranial-hemorrhage
#14
Joshua K Wong, Peter C Chen, Jennifer Falvey, Amber L Melvin, Alcina K Lidder, Lisa M Lowenstein, Amrendra S Miranpuri, Peter A Knight, H Todd Massey
The safety of alternative vitamin K antagonist (VKA) reversal strategies in patients with left ventricular assist devices (LVAD's) who present with intracranial hemorrhage (ICH) are not well known. A review of LVAD patients with ICH from May 2008 to 2015 was conducted, comparing the safety and efficacy of 4-factor prothrombin complex concentrate-assisted VKA reversal (4F-PCC group, n = 10) to reversal with traditional agents alone (no-PCC group, n = 10). An analysis of a no-reversal strategy in selected patients (n = 11) with ICH was additionally performed...
September 2016: ASAIO Journal: a Peer-reviewed Journal of the American Society for Artificial Internal Organs
https://www.readbyqxmd.com/read/27170068/reversibility-of-apixaban-anticoagulation-with-a-four-factor-prothrombin-complex-concentrate-in-healthy-volunteers
#15
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
https://www.readbyqxmd.com/read/27076286/safety-and-efficacy-of-warfarin-reversal-with-four-factor-prothrombin-complex-concentrate-for-subtherapeutic-inr-in-intracerebral-hemorrhage
#16
Ryan M Rivosecchi, Joseph Durkin, David O Okonkwo, Bradley J Molyneaux
BACKGROUND: The use of vitamin K antagonists is an independent risk factor for the development of intracerebral hemorrhage (ICH). Four-factor prothrombin complex concentrate (4F-PCC) is recommended for urgent reversal of anticoagulation in this setting. The safety and efficacy of 4F-PCC in ICH with subtherapeutic levels of anticoagulation is yet to be determined. METHODS: This was a retrospective, observational study of 4F-PCC administration data from September 2013 to July 2015...
December 2016: Neurocritical Care
https://www.readbyqxmd.com/read/27046797/emergent-reversal-of-vitamin-k-antagonists-addressing-all-the-factors
#17
COMPARATIVE STUDY
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
https://www.readbyqxmd.com/read/27021851/is-there-a-difference-in-efficacy-safety-and-cost-effectiveness-between-3-factor-and-4-factor-prothrombin-complex-concentrates-among-trauma-patients-on-oral-anticoagulants
#18
COMPARATIVE STUDY
Alicia Mangram, Olakunle F Oguntodu, James K Dzandu, Alexzandra K Hollingworth, Scott Hall, Christina Cung, Jason Rodriguez, Igor Yusupov, Jeffrey F Barletta
PURPOSE: The aim of this study was to compare the efficacy, safety, and cost-effectiveness of 3-factor prothrombin complex concentrate (3F-PCC) vs 4-factor prothrombin complex concentrate PCC (4F-PCC) in trauma patients requiring reversal of oral anticoagulants. MATERIALS AND METHODS: All consecutive trauma patients with coagulopathy (international normalized ratio [INR] ≥1.5) secondary to oral anticoagulants who received either 3F-PCC or 4F-PCC from 2010 to 2014 at 2 trauma centers were reviewed...
June 2016: Journal of Critical Care
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
#19
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/26619030/clinical-applications-of-4-factor-prothrombin-complex-concentrate-a-practical-pathologist-s-perspective
#20
REVIEW
David Unold, Christopher A Tormey
A 4-factor prothrombin complex concentrate (4F-PCC), containing therapeutic doses of vitamin K-dependent coagulation factors, was recently licensed in the United States for reversal of vitamin K antagonist therapy. However, given the emergence of several oral anticoagulants for which there are no specific reversal agents, and the existence of many other complex bleeding disorders, it is likely that clinicians will seek to use 4F-PCCs for any number of off-label indications. Thus, the goal of this review is to explore practical issues regarding 4F-PCC, with an emphasis on issues relevant to blood bankers and pathologists...
December 2015: Archives of Pathology & Laboratory Medicine
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