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Factor VII AND anticoagulants bleeding

Eric Paulus, Kathy Komperda, Gabriel Park, Julie Fusco
Factor VII (FVII) deficiency is the most prevalent rare bleeding disorder in the USA and affects approximately 1 out of every 500,000 people. Warfarin inhibits the synthesis of FVII, in addition to other clotting factors. Warfarin is contraindicated in patients with bleeding tendencies or blood dyscrasias; therefore, the literature regarding the use of warfarin in FVII deficiency is very limited. We report a successful re-challenge of warfarin therapy in a patient with FVII deficiency. A 70-year-old woman with FVII deficiency experienced a significant decrease in FVII activity and subsequent vaginal bleeding roughly 5 weeks after starting warfarin for atrial fibrillation...
December 2016: Drug Safety—Case Reports
B Schenk, P Würtinger, W Streif, W Sturm, D Fries, M Bachler
BACKGROUND: In major bleeding events, the new direct oral anticoagulants pose a great challenge for physicians. The aim of the study was to test for ex vivo reversal of the direct oral anticoagulant rivaroxaban with various non-specific reversal agents: prothrombin complex concentrate (PCC), activated prothrombin complex concentrate (aPCC), recombinant activated factor VII (rFVIIa), and fibrinogen concentrate (FI). METHODS: Blood was obtained from healthy volunteers and from patients treated with rivaroxaban...
November 2016: British Journal of Anaesthesia
Leyla Pourgholi, Hamidreza Goodarzynejad, Ali Mandegary, Shayan Ziaee, Azita Hajhosseini Talasaz, Arash Jalali, Mohammadali Boroumand
BACKGROUND: Bleeding episodes commonly occur in patients on warfarin treatment even in those within therapeutic range of international normalized ratio (INR). The objective of this study was to investigate the effects of the 8 examined polymorphisms on the risk of bleeding complications in a sample of Iranian patients. METHODS: A total of 552 warfarin treated patients who maintained on a target INR level of 2.0-3.5 for at least three consecutive intervals were enrolled from those attended our anticoagulation clinics...
October 15, 2016: Toxicology and Applied Pharmacology
Mareike K Körber, Elisabeth Langer, Lutz Kaufner, Michael Sander, Christian Von Heymann
BACKGROUND: A bleeding patient undergoing therapy with new oral anticoagulants is every clinician's nightmare as no specific reversal agent is available yet. This in vitro study investigated the effect of prothrombin complex concentrate (PCC), recombinant activated factor VII (rFVIIa) and activated prothrombin complex concentrate (aPCC) on supratherapeutic rivaroxaban concentrations using standard laboratory parameters (prothrombin time [PT], activated partial thromboplastin time [aPTT] and PT ratio) and thromboelastometry (clotting time [CT])...
2016: Blood Transfusion, Trasfusione del Sangue
Suna Kang, Hoi Soo Yoon, Eun Hye Lee
The objective of this study is to analyze the major causes of abnormal findings seen in the preoperative coagulation tests of asymptomatic pediatric patients and to discuss the usefulness of coagulation tests prior to minor surgery. Among patients who received minor surgery in Kyung Hee University Medical Center from March 2008 to April 2015, a total of 7114 pediatric patients (ages 1-18) were included in our study. Of these, 226 (3.1%) were referred to the pediatrics hematology-oncology department because of abnormal preoperative coagulation tests...
May 2016: Pediatric Hematology and Oncology
S V Mallett, A Sugavanam, D A Krzanicki, S Patel, R H Broomhead, B R Davidson, A Riddell, A Gatt, P Chowdary
The international normalised ratio is frequently raised in patients who have undergone major liver resection, and is assumed to represent a potential bleeding risk. However, these patients have an increased risk of venous thromboembolic events, despite conventional coagulation tests indicating hypocoagulability. This prospective, observational study of patients undergoing major hepatic resection analysed the serial changes in coagulation in the early postoperative period. Thrombin generation parameters and viscoelastic tests of coagulation (thromboelastometry) remained within normal ranges throughout the study period...
June 2016: Anaesthesia
K Varadi, S Tangada, M Loeschberger, P Montsch, G Schrenk, B Ewenstein, P L Turecek
INTRODUCTION: FEIBA(®) consists of zymogens and traces of activated forms of procoagulant factors II, VII, IX, X, anticoagulants protein C and TFPI, and small amounts of cofactors FV, FVIII and protein S, in a balanced ratio. As shown previously, FII-FXa complex plays a key role in FEIBA's mode of action (MoA). METHODS: Thrombin generation (TG) was measured by spiking coagulation factors, cofactors and inhibitors to high titer FVIII inhibitor plasma, and in plasma samples from patients in a phase 3 clinical study evaluating the safety and efficacy of FEIBA prophylaxis in haemophilia A patients with inhibitors...
July 2016: Haemophilia: the Official Journal of the World Federation of Hemophilia
Hans-Christoph Diener, James Aisenberg, Jack Ansell, Dan Atar, Günter Breithardt, John Eikelboom, Michael D Ezekowitz, Christopher B Granger, Jonathan L Halperin, Stefan H Hohnloser, Elaine M Hylek, Paulus Kirchhof, Deirdre A Lane, Freek W A Verheugt, Roland Veltkamp, Gregory Y H Lip
The choice of oral anticoagulant (OAC) for patients with atrial fibrillation (AF) may be influenced by individual clinical features or by patterns of risk factors and comorbidities. We reviewed analyses of subgroups of patients from trials of vitamin K antagonists vs. non-vitamin K oral anticoagulants (NOACs) for stroke prevention in AF with the aim to identify patient groups who might benefit from a particular OAC more than from another. In addition, we discuss the timing of initiation of anticoagulation. In the second of a two-part review, we discuss the use of NOAC for stroke prevention in the following subgroups of patients with AF: (vii) secondary stroke prevention in patients after stroke or transient ischaemic attack (TIA), (viii) patients with acute stroke requiring thrombolysis or thrombectomy, (ix) those initiating or restarting OAC treatment after stroke or TIA, (x) those with renal impairment on dialysis, (xi) the elderly, (xii) those at high risk of gastrointestinal bleeding, and (xiii) those with hypertension...
February 4, 2016: European Heart Journal
Páll T Onundarson, Charles W Francis, Olafur S Indridason, David O Arnar, Einar S Bjornsson, Magnus K Magnusson, Sigurdur J Juliusson, Hulda M Jensdottir, Brynjar Vidarsson, Petur S Gunnarsson, Sigrun H Lund, Brynja R Gudmundsdottir
BACKGROUND: Rapid fluctuations in factor VII during warfarin anticoagulation change the international normalised ratio (INR) but contribute little to the antithrombotic effect. We aimed to assess non-inferiority of anticoagulation stabilisation with a warfarin monitoring method affected only by factors II and X (Fiix-prothrombin time [Fiix-PT]) compared with standard PT-INR monitoring that includes factor VII measurement as well. METHODS: The Fiix trial was a single centre, double-blind, prospective, non-inferiority, randomised controlled clinical trial...
June 2015: Lancet Haematology
Konstantinos N Aronis, Elaine M Hylek
Non-vitamin K oral anticoagulants (NOACs) have been a major addition to our therapeutic armamentarium. They are at least as effective as warfarin in the thromboprophylaxis of non-valvular atrial fibrillation and management of thromboembolic disease, with a more favorable safety profile. Their predictable pharmacokinetics and pharmacodynamics allow for a fixed oral dosing without the need for anticoagulation monitoring. A major concern regarding NOACs is the lack of a readily available antidote to reverse their anticoagulation effect in case of life-threatening bleeding or need for emergent surgery...
February 2016: Journal of Thrombosis and Thrombolysis
Masahiro Yasaka
The nonvitamin K antagonist oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban, and edoxaban are associated with an equal or lower incidence of stroke and systemic embolism and a much lower incidence of intracranial hemorrhage and hemorrhagic stroke than warfarin is, without the need for routine laboratory monitoring. However, reversal strategies are not currently established in the case of NOAC-related hemorrhagic stroke. In emergency situations, well-defined management for NOAC-related hemorrhagic stroke may improve clinical outcomes...
2015: Frontiers of Neurology and Neuroscience
Stefan Cordes, Morie A Gertz, Francis K Buadi, Yi Lin, Martha Q Lacy, Prashant Kapoor, Shaji K Kumar, Arleigh McCurdy, Angela Dispenzieri, David Dingli, Suzanne R Hayman, William J Hogan, Rajiv K Pruthi
Acquired factor X deficiency and associated haemorrhage can be consequences of immunoglobulin light chain amyloidosis. There are limited data on the safety and efficacy of autologous stem cell transplant (ASCT) on factor X deficiency. We retrospectively reviewed immunoglobulin light chain amyloidosis patients with factor X levels below 50%, not on chronic anticoagulation who underwent ASCT at the Mayo Clinic, Rochester, Minnesota, USA, between April 1995 and December 2011. Twenty-seven of 358 patients (7.5%) met study criteria...
January 2016: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
Rachel Curtis, Alexandra Schweitzer, Janet van Vlymen
PURPOSE: Patients treated with warfarin for therapeutic anticoagulation present a challenge for the perioperative management of urgent and emergent surgery. Anticoagulation must be reversed prior to most surgical procedures to prevent intraoperative bleeding. The purpose of this module is to review the options for urgent reversal of warfarin anticoagulation and the indications for each reversal agent. Selection of the appropriate agent is important to reduce unnecessary complications of treatment and to achieve optimal reversal of anticoagulation...
June 2015: Canadian Journal of Anaesthesia, Journal Canadien D'anesthésie
M C A Müller, M Straat, J C M Meijers, J H Klinkspoor, E de Jonge, M S Arbous, M J Schultz, M B Vroom, N P Juffermans
BACKGROUND: Coagulopathy has a high prevalence in critically ill patients. An increased International Normalized Ratio (INR) is a common trigger to transfuse fresh frozen plasma (FFP), even in the absence of bleeding. Therefore, FFP is frequently administered to these patients. However, the efficacy of FFP in correcting hemostatic disorders in non-bleeding recipients has been questioned. OBJECTIVES: To assess whether INR prolongation parallels changes in the results of other tests investigating hemostasis, and to evaluate the coagulant effects of a fixed dose of FFP in non-bleeding critically ill patients with a coagulopathy...
June 2015: Journal of Thrombosis and Haemostasis: JTH
F Hidalgo, A Gómez-Luque, R Ferrandis, J V Llau, J de Andrés, C Gomar, P Sierra, J Castillo, L M Torres
There is an almost unanimous consensus on the management of the direct new oral anticoagulants, dabigatran, rivaroxaban, and apixaban in elective surgery. However, this general consensus does not exist in relation with the direct new oral anticoagulants use in emergency surgery, especially in the bleeding patient. For this reason, a literature review was performed using the MEDLINE-PubMed. An analysis was made of the journal articles, reviews, systematic reviews, and practices guidelines published between 2000 and 2014 using the terms "monitoring" and "reversal"...
October 2015: Revista Española de Anestesiología y Reanimación
Áron Altorjay, Éva Szabó, Zoltán Boda, Ludwig Kramer, Leock Y Ngo, Werner Engl, Clair L Firth, Erik R Ahlstrom, David M Gelmont, Ingrid Pabinger
INTRODUCTION: Prothrombin complex concentrates (PCCs) are a common treatment option for the reversal of oral anticoagulation with vitamin K antagonists (VKAs). This study assessed efficacy and safety of Prothromplex Total®. MATERIALS AND METHODS: Patients (≥18 years) with acquired prothrombin complex coagulation factor deficiency (international normalized ratio [INR] ≥ 2 at screening) due to oral VKAs, requiring reversal of anticoagulation, were treated with 25, 35, or 50 IU/kg BW PCC...
March 2015: Thrombosis Research
T F Lüscher, J Steffel
UNLABELLED: Clot formation in the circulation is a physiological mechanism preventing bleeding at sites of loss of vascular integrity. Clot formation may also occur intravascularly under pathological conditions, e.g. leading to myocardial infarction, stroke, and critical limb ischaemia. Clot formation involves activation of the coagulation cascade and of platelets eventually leading to an occlusive clot. In the venous circulation, clots are rich in erythrocytes and fibrin, while in the arterial circulation platelets predominate...
2016: Hämostaseologie
Tomas L Lindahl, Maria Wallstedt, Kerstin M Gustafsson, Egon Persson, Andreas Hillarp
The number of patients on antithrombotic treatment due to atrial fibrillation and venous thromboembolism is increasing fast due to an aging population. A growing proportion will be treated with novel oral anticoagulants, the first in clinical use was the direct oral thrombin inhibitor dabigatran (Pradaxa®). A small percentage of the patients on dabigatran will experience serious bleeding or be in need of urgent surgery. The aim of this study was to test the effects of different hemostatic agents in potentially reversing the anticoagulant effects in vitro in blood or platelet-rich plasma (PRP) spiked with dabigatran...
March 2015: Thrombosis Research
Deborah M Siegal
Target-specific oral anticoagulants (TSOACs) dabigatran, rivaroxaban and apixaban are approved for the prevention and treatment of thromboembolism in several clinical settings. Bleeding is the major complication of anticoagulant therapy, including TSOACs, and anticoagulant reversal strategies are highly desired for the management of anticoagulant-associated major bleeding in addition to maximum supportive care and procedural/surgical intervention. Unlike VKAs for which vitamin K and coagulation factor replacement with prothrombin complex concentrate (PCC) can restore hemostasis, there are no clinically available agents proven to reverse TSOAC anticoagulant effect and ameliorate TSOAC-related major bleeding...
April 2015: Journal of Thrombosis and Thrombolysis
Scott W Yates
Three target-specific oral anticoagulants (TSOACs)-dabigatran, rivaroxaban, and apixaban-have been approved by the FDA to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; however, no agents are currently approved to reverse the anticoagulant effects of these TSOACs in cases of active bleeding. This review discusses the benefits and risks of these TSOACs from a clinician's perspective, with a focus on the interruption of treatment for either elective or emergent surgery, monitoring, and reversal of anticoagulation...
December 2014: P & T: a Peer-reviewed Journal for Formulary Management
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