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https://www.readbyqxmd.com/read/29369801/prediction-of-human-pharmacokinetics-of-activated-recombinant-factor-vii-and-b-domain-truncated-factor-viii-from-animal-population-pharmacokinetic-models-of-haemophilia
#1
Malte Selch Larsen, Rasmus Vestergaard Juul, Andreas Velsing Groth, Ulrika S H Simonsson, Annemarie T Kristensen, Tom Knudsen, Henrik Agersø, Mads Kreilgaard
Various experimental animal models are used in haemophilia research, however, little is known about how well the different species predict pharmacokinetic (PK) profiles in haemophilia patients. The aim of the current study was to describe the plasma concentration-time profile of recombinant activated factor VII (rFVIIa) and recombinant factor VIII (rFVIII) in several experimental animal models using population PK modelling, and apply a simulation-based approach to evaluate how well the developed animal population PK models predict human PK...
January 21, 2018: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29366484/discussion-of-protocolized-warfarin-reversal-with-4-factor-prothrombin-complex-concentrate-versus-3-factor-prothrombin-complex-concentrate-with-recombinant-factor-viia
#2
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
https://www.readbyqxmd.com/read/29351237/bioengineering-of-rfviia-biopharmaceutical-and-structure-characterization-for-biosimilarity-assessment
#3
Othman Montacir, Houda Montacir, Murat Eravci, Andreas Springer, Stephan Hinderlich, Fereidoun Mahboudi, Amirhossein Saadati, Maria Kristina Parr
Eptacog alfa (NovoSeven®) is a vitamin K-dependent recombinant Factor VIIa produced by genetic engineering from baby hamster kidney (BHK) cells as a single peptide chain of 406 residues. After activation, it consists of a light chain (LC) of 152 amino and a heavy chain (HC) of 254 amino acids. Recombinant FVIIa undergoes many post-translational modifications (PTMs). The first ten glutamic acids of the N-terminal moiety are γ-carboxylated, Asn145 and Asn322 are N-glycosylated, and Ser52 and Ser60 are O-glycosylated...
January 19, 2018: Bioengineering
https://www.readbyqxmd.com/read/29338845/protocolized-warfarin-reversal-with-4-factor-prothrombin-complex-concentrate-versus-3-factor-prothrombin-complex-concentrate-with-recombinant-factor-viia
#4
Cassie A Barton, Marissa Hom, Nathan B Johnson, Jon Case, Ran Ran, Martin Schreiber
INTRODUCTION: Life-threatening bleeding can complicate warfarin therapy. Rapid anticoagulant reversal via replacement of vitamin-K dependent clotting factors is essential for hemostasis. We compare two methods of rapid factor replacement for warfarin reversal. METHODS: A retrospective cohort study of warfarin-treated patients experiencing life-threatening bleeding who received a reversal protocol comprised of 4F PCC or 3F PCC and rFVIIa was performed. Demographic, clinical and anticoagulant reversal information, and all adverse events attributed to warfarin reversal were recorded...
January 5, 2018: American Journal of Surgery
https://www.readbyqxmd.com/read/29334511/evaluation-of-recombinant-factor-viia-tranexamic-acid-and-desmopressin-to-reduce-prasugrel-related-bleeding-a-randomised-placebo-controlled-study-in-a-rabbit-model
#5
Fanny Bonhomme, Thomas Lecompte, Charles M Samama, Anne Godier, Pierre Fontana
BACKGROUND: Prasugrel is a thienopyridine that inhibits platelet aggregation more rapidly and effectively than clopidogrel, with an increased bleeding risk. OBJECTIVE: The current study aimed to evaluate the efficacy of three nonspecific haemostatic drugs - recombinant activated factor VII (rFVIIa), tranexamic acid and desmopressin (DDAVP) - to limit blood loss after administration of prasugrel in a rabbit model of bleeding while also evaluating any prothrombotic effects...
March 2018: European Journal of Anaesthesiology
https://www.readbyqxmd.com/read/29332420/activated-factor-7-versus-4-factor-prothrombin-complex-concentrate-for-critical-bleeding-post-cardiac-surgery
#6
Sarah L Mehringer, Zachary Klick, Jonathan Bain, Elizabeth B McNeely, Sreekumar Subramanian, Lawrence J Pass, Davis Drinkwater, V Seenu Reddy
BACKGROUND: Recombinant and plasma-derived factor products, such as activated factor seven (rFVIIa) and four-factor prothrombin complex concentrate (4-factor PCC), have been used off-label for bleeding after cardiac surgery, but little evidence has been published regarding their efficacy and safety. OBJECTIVE: To determine whether there is a difference in chest tube output in patients who have received 4-factor PCC or rFVIIa for critical postoperative bleeding associated with cardiovascular surgery...
January 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29217234/outcomes-following-three-factor-inactive-prothrombin-complex-concentrate-versus-recombinant-activated-factor-vii-administration-during-cardiac-surgery
#7
Patrick C Harper, Mark M Smith, Nathan J Brinkman, Melissa A Passe, Darrell R Schroeder, Sameh M Said, Gregory A Nuttall, William C Oliver, David W Barbara
OBJECTIVE: To compare outcomes following inactive prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa) administration during cardiac surgery. DESIGN: Retrospective propensity-matched analysis. SETTING: Academic tertiary-care center. PARTICIPANTS: Patients undergoing cardiac surgery requiring cardiopulmonary bypass who received either rFVIIa or the inactive 3-factor PCC. INTERVENTIONS: Outcomes following intraoperative administration of rFVIIa (263) or factor IX complex (72) as rescue therapy to treat bleeding...
July 12, 2017: Journal of Cardiothoracic and Vascular Anesthesia
https://www.readbyqxmd.com/read/29204261/recombinant-human-factor-viia-rfviia-in-hemophilia-mode-of-action-and-evidence-to-date
#8
REVIEW
Muriel Giansily-Blaizot, Jean-François Schved
Recombinant activated factor VII (rFVIIa) is a bypassing agent widely used both in the treatment and prevention of hemorrhagic complications due to hemophilia with inhibitor. In such cases, antihemophilic factors cannot be used. The normal physiology of factor VII/ factor VIIa (FVII/FVIIa) in the hemostatic process requires the presence of tissue factor (TF) that links to FVII leading to a FVIIa-TF complex which activates both factor X and factor IX. The therapeutic use of rFVIIa requires high amount of FVIIa...
December 2017: Therapeutic Advances in Hematology
https://www.readbyqxmd.com/read/29080548/efficacy-of-recombinant-factor-viia-for-severe-bleeding-complicated-by-platelet-transfusion-refractoriness-in-patients-with-hematologic-malignancies
#9
Tiantian Chu, Yaqiong Tang, Hong Wang, Jiaqian Qi, Ying Zhao, Tingting Pan, Xiaowen Tang, Huiying Qiu, Chengcheng Fu, Changgeng Ruan, De-Pei Wu, Yue Han
INTRODUCTION: Severe bleeding with platelet transfusion refractoriness (PTR) is a common complication associated with reduced survival in patients with hematologic malignancies. The present study aimed to evaluate the efficacy of recombinant factor VIIa (rFVIIa) for severe bleeding complicated by PTR. MATERIALS AND METHODS: Sixty-four patients suffering from severe bleeding with PTR hospitalized in our center between September 2012 and December 2016 were enrolled in this study...
December 2017: Thrombosis Research
https://www.readbyqxmd.com/read/29080382/factor-xiii-cotreatment-with-hemostatic-agents-in-hemophilia-a-increases-fibrin-%C3%AE-chain-crosslinking
#10
J D Beckman, L A Holle, A S Wolberg
Essentials Factor XIII (FXIII)-mediated fibrin crosslinking is delayed in hemophilia. We determined effects of FXIII cotreatment with hemostatic agents on clot parameters. FXIII cotreatment accelerated FXIII activation and crosslinking of fibrin and α2 -antiplasmin. These data provide biochemical rationale for FXIII cotreatment in hemophilia. SUMMARY: Background Hemophilia A results from the absence, deficiency or inhibition of factor VIII. Bleeding is treated with hemostatic agents (FVIII, recombinant activated FVII [rFVIIa], anti-inhibitor coagulation complex [FEIBA], or recombinant porcine FVIII [rpFVIII])...
October 28, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/29078928/antithrombotic-reversal-agents
#11
REVIEW
Matthew D Wilson, Jonathan E Davis
The actively bleeding anticoagulated patient presenting to the emergency department requires rapid evaluation and treatment, which is made increasingly complicated by the ever-evolving antithrombotic treatment options used in medicine. Even with excellent supportive care, the timeliness with which reversal decisions need to be made continues to demand of the emergency practitioner a familiarity with the properties and general characteristics of a variety of antithrombotic agents. Reversal options vary and may include vitamin K, FFP, PCC, rFVIIa, platelets, and desmopressin, among others...
December 2017: Hematology/oncology Clinics of North America
https://www.readbyqxmd.com/read/29051804/review-of-recombinant-anti-haemophilic-porcine-sequence-factor-viii-in-adults-with-acquired-haemophilia-a
#12
REVIEW
Emma Fosbury, Anja Drebes, Anne Riddell, Pratima Chowdary
Acquired haemophilia A (AHA) is a rare, serious bleeding disorder most often encountered in elderly patients. The mainstay of haemostatic management is with bypassing agents (BPAs) including recombinant activated factor VII (rFVIIa) and activated prothrombin complex concentrates (aPCCs). Their major limitation is incomplete efficacy, potential risk for thrombosis and the lack of routine laboratory assays for monitoring treatment response. Plasma-derived porcine FVIII (pd-pFVIII, Hyate C(®)), first used in the 1950s for the management of congenital haemophilia, has sufficient sequence homology to be haemostatic in humans, but the lack of complete homology facilitates efficacy even in the presence of human allo- and autoantibodies against human FVIII (hFVIII)...
September 2017: Therapeutic Advances in Hematology
https://www.readbyqxmd.com/read/28967418/recombinant-factor-viia-use-in-acute-type-a-aortic-dissection-repair-a-multicenter-propensity-score-matched-report-from-the-nordic-consortium-for-acute-type-a-aortic-dissection
#13
Igor Zindovic, Johan Sjögren, Anders Ahlsson, Henrik Bjursten, Simon Fuglsang, Arnar Geirsson, Richard Ingemansson, Emma C Hansson, Ari Mennander, Christian Olsson, Emily Pan, Susann Ullén, Tomas Gudbjartsson, Shahab Nozohoor
BACKGROUND: Surgery for acute type A aortic dissection (ATAAD) is often complicated by excessive bleeding. Recombinant factor VIIa (rFVIIa) effectively treats refractory bleeding associated with ATAAD surgery; however, adverse effects of rFVIIa in these patients have not been fully assessed. Here we evaluated rFVIIa treatment in ATAAD surgery using the Nordic Consortium for Acute Type A Aortic Dissection (NORCAAD) database. METHODS: This was a multicenter, propensity score-matched, retrospective study...
August 24, 2017: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/28944952/bypassing-agent-prophylaxis-in-people-with-hemophilia-a-or-b-with-inhibitors
#14
REVIEW
Chatree Chai-Adisaksopha, Sarah J Nevitt, Mindy L Simpson, Maissaa Janbain, Barbara A Konkle
BACKGROUND: People with hemophilia A or B with inhibitors are at high risk of bleeding complications. Infusion of bypassing agents, such as recombinant activated FVII (rFVIIa) and plasma-derived activated prothrombin complex concentrate, are suggested as alternative therapies to factor VIII (haemophilia A) or IX (haemophilia B) for individuals who no longer respond to these treatments because they develop inhibitory antibodies. The ultimate goal of treatment is to preserve the individual's joints, otherwise destroyed by recurrent bleeds...
September 25, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28934519/intra-pericardial-use-of-recombinant-factor-viia-in-a-patient-with-acute-hemorrhagic-pericardial-effusion-following-transcutaneous-aortic-valve-replacement-a-case-report
#15
Vanya Jaitly, Kimberly Klein, Hlaing Tint, Alice Chen, Paul Allison, Bindu Akkanti, Pranav Loyalka, Brian Castillo
Perioperative bleeding can be a serious life-threatening complication in adult patients undergoing cardiac surgery, given the older age and additional comorbidities present in this patient population. The standard treatment options include transfusion of blood components and surgical re-exploration. We report the first case of an elderly female patient treated with local administration of recombinant factor VIIa (rFVIIa) for intractable hemorrhagic pericardial effusion, which developed following a transcutaneous aortic valve replacement (TAVR) procedure for severe aortic stenosis...
August 1, 2017: Laboratory Medicine
https://www.readbyqxmd.com/read/28932824/factor-viia-interaction-with-epcr-modulates-the-hemostatic-effect-of-rfviia-in-hemophilia-therapy-mode-of-its-action
#16
Shiva Keshava, Jagan Sundaram, Anuradha Rajulapati, Charles Esmon, Usha Pendurthi, L Vijaya Mohan Rao
Recent studies established that clotting factor VIIa (FVIIa) binds endothelial cell protein C receptor (EPCR). It has been speculated that FVIIa interaction with EPCR might augment the hemostatic effect of rFVIIa in therapeutic conditions. The present study is carried out to investigate the mechanism by which FVIIa interaction with EPCR contributes to the hemostatic effect of rFVIIa in hemophilia therapy. Active-site inhibited FVIIa, which is capable of binding to EPCR but has no ability to activate factor X, reduced the concentration of rFVIIa required to correct the bleeding following the saphenous vein injury in mouse hemophilia model systems...
June 27, 2017: Blood Advances
https://www.readbyqxmd.com/read/28889826/recombinant-factor-viia-as-a-rescue-therapy-in-severe-haemoptysis-in-a-patient-with-a-fontan-circulation
#17
Thomas W Mason, Andrew Retter, Gareth J Morgan
We describe the successful use of recombinant factor VIIa (rFVIIa) in the control of massive haemoptysis in a 17-year-old patient with a Fontan circulation. The patient was intubated and ventilated in the ICU with deteriorating gas exchange. Conventional methods to control the haemoptysis were ineffective, and rFVIIa was successfully administered as a rescue therapy. rFVIIa is a powerful pro-thrombotic agent, which is only licensed in haemophiliacs with acquired inhibitors to anticoagulation. It has been used off-license in the treatment of massive haemorrhage, although a Cochrane review did not show any significant benefit; however, it may have a role as a rescue therapy where alternatives options have been exhausted after careful risk-benefit analysis...
September 11, 2017: Cardiology in the Young
https://www.readbyqxmd.com/read/28726538/marked-bleeding-diathesis-in-patients-with-platelet-dysfunction-due-to-a-novel-mutation-in-rasgrp2-encoding-caldag-gefi-p-gly305asp
#18
Emilse Bermejo, Maria F Alberto, David S Paul, Aaron A Cook, Paquita Nurden, Analia Sanchez Luceros, Alan T Nurden, Wolfgang Bergmeier
Congenital platelet function disorders are often the result of defects in critical signal transduction pathways required for platelet adhesion and clot formation. Mutations affecting RASGRP2, the gene encoding the Rap GTPase activator, CalDAG-GEFI, give rise to a novel, and rare, group of platelet signal transduction abnormalities. We here report platelet function studies for two brothers (P1 and P2) expressing a novel variant of RASGRP2, CalDAG-GEFI(p.Gly305Asp). P1 and P2 have a lifelong history of bleeding with severe epistaxis successfully treated with platelet transfusions or rFVIIa...
July 20, 2017: Platelets
https://www.readbyqxmd.com/read/28693567/protocol-based-invasive-intracranial-pressure-monitoring-in-acute-liver-failure-feasibility-safety-and-impact-on-management
#19
Venkatakrishna Rajajee, Robert J Fontana, Anthony J Courey, Parag G Patil
BACKGROUND: Acute liver failure (ALF) may result in elevated intracranial pressure (ICP). While invasive ICP monitoring (IICPM) may have a role in ALF management, these patients are typically coagulopathic and at risk for intracranial hemorrhage (ICH). Contemporary ICP monitoring techniques and coagulopathy reversal strategies may be associated with a lower risk of hemorrhage. Our objective was to evaluate the safety, feasibility, impact on clinical management and outcomes associated with protocol-directed use of IICPM in ALF...
July 11, 2017: Critical Care: the Official Journal of the Critical Care Forum
https://www.readbyqxmd.com/read/28689155/combination-of-hemostatic-therapies-for-treatment-of-patients-with-hemophilia-a-and-inhibitors
#20
Tami Livnat, Ivan Budnik, Sarina Levy-Mendelovich, Einat Avishai, Mudi Misgav, Assaf Arie Barg, Aharon Lubetsky, Tami Brutman-Barazani, Gili Kenet
BACKGROUND: Therapy application and monitoring of patients with hemophilia A (HA) and inhibitors are challenging. In the current study, combined FVIII - bypass therapy was implemented for a cohort of severe HA patients with inhibitors. METHODS: Plasma of 15 HA patients with inhibitors was spiked ex vivo with FVIII, rFVIIa, FEIBA and their combinations and thrombin generation (TG) was studied. Some patients who experienced hemarthroses or required minor surgeries were treated by a combined concomitant administration of FVIII+FEIBA as IV bolus doses...
June 27, 2017: Blood Cells, Molecules & Diseases
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