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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...
January 24, 2017: American Journal of Emergency Medicine
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
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
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
Karen Berger, Lina Lin, Christine Lesch
No abstract text is available yet for this article.
December 2016: Critical Care Medicine
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
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
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...
July 5, 2016: Journal of Critical Care
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
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
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
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
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
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
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
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
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
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
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