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Prothrombin Complex Concentrate

H-H Brackmann, G C White, E Berntorp, T Andersen, C Escuriola-Ettingshausen
Development of inhibitory antibodies to infused factor VIII (FVIII) concentrates continues to be the most serious complication of haemophilia A management. Induction of immune tolerance by administering high doses of FVIII concentrate (antigen) and prothrombin complex concentrates to control bleeding was originated in the 1970s in Bonn, Germany, by Dr Hans-Hermann Brackmann, and became known as the Bonn protocol. ITI transformed the life of the index patient, who was 19 years of age when he began treatment, and dramatically improved the medical landscape for all patients with haemophilia and inhibitors...
April 2018: Haemophilia: the Official Journal of the World Federation of Hemophilia
Rahat A Abdoellakhan, Nakisa Khorsand, Reinier M Van Hest, Nic Veeger, Ewoud Ter Avest, Paula F Ypma, Laura M Faber, Karina Meijer
INTRODUCTION: There is currently little evidence for the optimal dosing strategy of four-factor prothrombin complex concentrates (PCC) in vitamin K antagonist (VKA)-related bleeds. The generally accepted dosing strategy is the use of a variable dose calculated using patient-specific characteristics as per manufacturer's instruction. However, evidence exists that the use of a fixed low dose of 1000 international units of factor IX (IU fIX) might also suffice. Recent studies indicate that in terms of haemostatic effectiveness, the fixed dosing strategy might be even superior to the variable dosing strategy...
March 14, 2018: BMJ Open
Andrew McPhail, Dominick Jokel
The question of this review is: what is the effectiveness of Kcentra/Beriplex/Confidex compared to plasma for international normalized ratio (INR) reduction in adult patients (18 years and over) on any vitamin K antagonist therapy?
March 2018: JBI Database of Systematic Reviews and Implementation Reports
Massimo Franchini, Pier Mannuccio Mannucci
One of the most challenging issues facing us in the treatment of haemophilia is the development of alloantibodies against infused factor VIII (FVIII) or factor IX (FIX). Inhibitors render factor replacement therapy ineffective, exposing patients to an unacceptably high risk of morbidity and mortality. Besides the well-known bypassing agents (i.e. activated prothrombin complex concentrate and recombinant activated factor VII) used to treat or prevent bleeding in haemophilia patients with inhibitors, there is growing interest in a new class of therapeutic agents which act by enhancing coagulation (i...
February 14, 2018: Blood Transfusion, Trasfusione del Sangue
Rachael Scott, Brian Kersten, Jeanne Basior, Megan Nadler
BACKGROUND: Different strategies exist for dosing four-factor prothrombin complex concentrate (PCC4) for international normalized ratio (INR) reversal in the setting of life-threatening bleeding. Fixed doses ranging from 1000 IU to 1750 IU have demonstrated efficacy similar to weight-based dosing, however, few studies look exclusively at intracranial hemorrhage (ICH). OBJECTIVE: Our aim was to evaluate whether a fixed dose of 1000 IU of PCC4 achieves INR reversal similar to weight-based dosing in patients with ICH who were anticoagulated with warfarin...
March 3, 2018: Journal of Emergency Medicine
A Shaun Rowe, Scott K Dietrich, John W Phillips, Kaci E Foster, Joshua R Canter
OBJECTIVES: To compare the international normalized ratio normalization efficacy of activated prothrombin complex concentrates and 4-factor prothrombin complex concentrates and to evaluate the thrombotic complications in patients treated with these products for warfarin-associated hemorrhage. DESIGN: Retrospective, Multicenter Cohort. SETTING: Large, Community, Teaching Hospital. PATIENTS: Patients greater than 18 years old and received either activated prothrombin complex concentrate or 4-factor prothrombin complex concentrate for the treatment of warfarin-associated hemorrhage...
March 1, 2018: Critical Care Medicine
Xuefeng Hu, Ying Xiao, Chuan Yu, Yinglin Zuo, Wen Yang, Xinan Wang, Baohua Gu, Jing Li
Factor Xa (FXa) is a serine protease that plays key roles in linking the intrinsic and extrinsic coagulation pathways to the final common pathway. DJT06001 is an oral, highly specific and direct FXa inhibitor for the prevention and treatment of thromboembolic diseases. We characterized the compound in vitro and studied its in vivo activity in rat thrombosis models, as well as bleeding risk and Pharmacokinetics and Pharmacodynamics (PK/PD) relationship. DJT06001 inhibited free FXa with an inhibitory constant (Ki) of 0...
February 21, 2018: European Journal of Pharmacology
Anita Árokszállási, Katalin Rázsó, Péter Ilonczai, Zsolt Oláh, Zsuzsanna Bereczky, Zoltán Boda, Ágota Schlammadinger
: In acquired haemophilia A (AHA), risk for recurrent bleeding exists until the inhibitor is detectable. Thus, patients with persisting inhibitor may benefit from prophylaxis with activated prothrombin complex concentrate (aPCC). Potential thromboembolic complications and cost are also factors to consider. Today, no high level evidence or clear recommendations are available on aPCC prophylaxis in AHA. Recently, a small prospective study demonstrated a favourable outcome with short-term, daily administered aPCC infusion...
February 22, 2018: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
Yesim Dargaud, Anne Lienhart, Maissaa Janbain, Sandra LeQuellec, Nathalie Enjolras, Claude Negrier
Emicizumab is a recombinant, humanized, bispecific, monoclonal antibody that bridges activated factor IX and factor X to restore the function of deficient factor VIII. Treatment of bleeding in patients with hemophilia and inhibitors involves the use of bypassing agents (BPA).These molecules are also used for the management of breakthrough bleeds in patients on prophylaxis with emicizumab, with increased concerns about the risks of combining two procoagulant drugs. Using thrombin generation assay, we tailored the dosage of activated prothrombin complex concentrate (APCC) and successfully treated an acute spontaneous arterial bleeding in a patient on prophylaxis with emicizumab 1...
February 22, 2018: Haematologica
Frédéric Lapostolle, Virginie Siguret, Anne-Céline Martin, Claire Pailleret, Bernard Vigué, Yves Zerbib, Karim Tazarourte
The recent emergence of 'non-VKA' oral anticoagulants may have led to some forgetting that vitamin K antagonists (VKA) are by far the most widely prescribed oral anticoagulants worldwide. Consequently, we decided to summarize the information available on them. This paper presents the problems facing emergency physicians confronted with patients on VKAs in 10 points, from pharmacological data to emergency management. Vitamin K antagonists remain preferable in many situations including in the elderly, in patients with extreme body weights, severe chronic kidney or liver disease or valvular heart disease, and in patients taking VKAs with well-controlled international normalized ratios (INRs)...
February 16, 2018: European Journal of Emergency Medicine: Official Journal of the European Society for Emergency Medicine
Bryan D Hayes, Michael E Winters, Steve B Rosenbaum, Mohannad F Allehyani, Gary M Vilke
BACKGROUND: In 2010, the U.S. Food and Drug Administration (FDA) approved dabigatran as the first non-warfarin oral anticoagulant for use in the United States. At the time of FDA approval, there was no antidote or effective treatment for dabigatran-induced hemorrhage. In 2015, the FDA approved idarucizumab for the treatment of dabigatran-induced hemorrhage. The purpose of this clinical practice statement is to evaluate the role of select reversal agents in the management of patients with dabigatran-associated bleeding...
February 15, 2018: Journal of Emergency Medicine
Chancey Carothers, Amanda Giancarelli, Joseph Ibrahim, Brandon Hobbs
BACKGROUND: Patients with traumatic intracranial hemorrhage (TIH) anticoagulated with warfarin are at an increased risk of mortality. Fresh frozen plasma (FFP) and vitamin K have been the standard treatment for warfarin reversal; however, guidelines now recommend the use of prothrombin complex concentrate (PCC) for warfarin reversal in patients with life-threatening bleeding. Our protocol uses one vial (∼1000 units) of activated PCC (aPCC) for warfarin reversal, regardless of the weight or presenting international normalized ratio (INR)...
March 2018: Journal of Surgical Research
Pratima Chowdary, Augustine Tang, Dale Watson, Martin Besser, Peter Collins, Michael Desmond Creagh, Hafiz Qureshi, Margaret Rokicka, Tim Nokes, Paul Diprose, Ravi Gill
A multicenter, retrospective, observational study of 4-factor prothrombin complex concentrate (PCC) and/or fresh frozen plasma (FFP) use within routine clinical care unrelated to vitamin K antagonists was conducted. The PCC was administered preprocedure for correction of coagulopathy (prophylactic cohort) and treatment of bleeding postsurgery (treatment cohort). Of the 445 patients included, 40 were in the prophylactic cohort (PCC alone [n = 16], PCC and FFP [n = 5], FFP alone [n = 19]) and 405 were in the treatment cohort (PCC alone [n = 228], PCC and FFP [n = 123], FFP alone [n = 54])...
January 1, 2018: Clinical and Applied Thrombosis/hemostasis
Ding Wen Wu, Yu Xia, Joan Uelinger, Stephen Forest, James Szymanski, Kala Mohandas, Ronald Walsh, Sadiqa Karim, Etan Marks, Evan Himchak, Ritu Gupta, Daniel Goldstein
BACKGROUND: Left ventricular assist device (LVAD) recipients undergoing heart transplantation have increased bleeding risk. We compared conventional warfarin reversal with fresh frozen plasma vs 4-factor prothrombin complex concentrate (PCC) and the effect on transfusion requirements, blood bank costs, and clinical outcomes. METHODS: A retrospective review identified 60 consecutive LVAD recipients undergoing heart transplantation divided into two groups: 30 (no PCC) received fresh frozen plasma and 30 (PCC) received PCC...
February 1, 2018: Annals of Thoracic Surgery
Shihoko Okabayashi, Satoru Ogawa, Kenichi A Tanaka, Takashi Nishiyama, Shusuke Takeshita, Yoshinobu Nakayama, Yasufumi Nakajima, Teiji Sawa, Toshiki Mizobe
OBJECTIVE: Point-of-care (POC) devices allow for prothrombin time/international normalized ratio (PT/INR) testing in whole blood (WB) and timely administration of plasma or prothrombin complex concentrate during cardiopulmonary bypass surgery. This study evaluated the sensitivities of a new POC PT test, a dry-hematology method with heparin neutralization technology (DRIHEMATO PT-S [DRI PT-S]; A&T Corporation, Kanagawa, Japan), and compared it with other POC tests currently available. DESIGN: Prospective, observational study...
December 29, 2017: Journal of Cardiothoracic and Vascular Anesthesia
Moustafa Younis, Mohamed Ray-Zack, Nadeem N Haddad, Asad Choudhry, Matthew C Hernandez, Kevin Wise, Martin D Zielinski
BACKGROUND: Coagulopathy can delay or complicate surgical diseases that require emergent surgical treatment. Prothrombin complex concentrates (PCC) provide concentrated coagulation factors which may reverse coagulopathy more quickly than plasma (FFP) alone. We aimed to determine the time to operative intervention in coagulopathic emergency general surgery patients receiving either PCC or FFP. We hypothesize that PCC administration more rapidly normalizes coagulopathy and that the time to operation is diminished compared to FFP alone...
February 1, 2018: World Journal of Surgery
Elizabeth A Messana, Suprat Saely, Scott R Millis, Phillip D Levy
: Previous studies suggest low, fixed-dose regimens of activated prothrombin complex concentrate [factor VIII inhibitor bypassing activity (FEIBA); 500 U for international normalized ratio (INR) < 5; 1000 U for INR > 5] is effective for reversal of warfarin-induced life-threatening bleeds. Little data are available on the use of high-dose, weight-based FEIBA for this indication. The objective of this study was to evaluate effectiveness and safety of high-dose, weight-based FEIBA (50 U/kg) vs...
March 2018: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
Rachel Van Dusen
INTRODUCTION: Life-threatening bleeding is the most feared complication of warfarin therapy. Rapid anticoagulant reversal via replacement of vitamin K dependent clotting factors is essential for hemostasis. METHODS: A retrospective cohort study of warfarin-treated patients experiencing a life-threatening bleed treated with a warfarin reversal protocol comprised of 4F PCC (post-implementation group) and those who received the prior reversal protocol of 3F PCC and rFVIIa (pre-implementation group) was performed...
January 5, 2018: American Journal of Surgery
Jerrold H Levy, James Douketis, Jeffrey I Weitz
The non-vitamin K antagonist oral anticoagulants (NOACs) include dabigatran, which inhibits thrombin, and apixaban, betrixaban, edoxaban, and rivaroxaban, which inhibit coagulation factor Xa. Although clinical studies of NOACs were conducted without antidotes, patient outcomes with major bleeding when receiving NOACs were no worse than those in patients treated with a vitamin K antagonist. Nonetheless, in patients with life-threatening bleeding or requiring urgent surgery, the capacity for rapid NOAC reversal is likely to increase patient safety...
January 18, 2018: Nature Reviews. Cardiology
Bettina Schenk, Stephanie Goerke, Ronny Beer, Raimund Helbok, Dietmar Fries, Mirjam Bachler
Background: Direct oral anticoagulants (DOACs) pose a great challenge for physicians in life-threatening bleeding events. The aim of this study was to test the efficacy of reversing the DOAC rivaroxaban using four-factor PCC (prothrombin complex concentrate), a non-specific reversing agent. Methods: Patients with life-threatening bleeding events during rivaroxaban treatment were included and administered 25 U kg-1 of PCC. Blood samples were collected immediately prior to as well as after PCC treatment at predefined time intervals...
2018: Thrombosis Journal
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