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Recombinant FVIIa

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https://www.readbyqxmd.com/read/28437748/rational-and-timely-haemostatic-interventions-following-cardiac-surgery-coagulation-factor-concentrates-or-blood-bank-products
#1
Mariann Tang, Christian Fenger-Eriksen, Per Wierup, Jacob Greisen, Jørgen Ingerslev, Vibeke Hjortdal, Benny Sørensen
BACKGROUND: Cardiac surgery may cause a serious coagulopathy leading to increased risk of bleeding and transfusion demands. Blood bank products are commonly first line haemostatic intervention, but has been associated with hazardous side effect. Coagulation factor concentrates may be a more efficient, predictable, and potentially a safer treatment, although prospective clinical trials are needed to further explore these hypotheses. This study investigated the haemostatic potential of ex vivo supplementation of coagulation factor concentrates versus blood bank products on blood samples drawn from patients undergoing cardiac surgery...
April 5, 2017: Thrombosis Research
https://www.readbyqxmd.com/read/28420729/factor-v-anticoagulant-cofactor-activity-that-targets-the-early-phase-of-coagulation
#2
Salvatore Santamaria, Natalia Reglińska-Matveyev, Magdalena Gierula, Rodney M Camire, James T B Crawley, David A Lane, Josefin Ahnström
Tissue factor pathway inhibitor (TFPI), the main inhibitor of initiation of coagulation, exerts an important anticoagulant role through the factor Xa (FXa)-dependent inhibition of tissue factor/factor VIIa (FVIIa). Protein S is a TFPI cofactor, enhancing the efficiency of FXa inhibition. TFPI can also inhibit prothrombinase assembly by directly interacting with coagulation factor V (FV) which has been activated by FXa. Since full-length TFPI associates with FV in plasma, we hypothesized that FV may influence TFPI inhibitory function...
April 18, 2017: Journal of Biological Chemistry
https://www.readbyqxmd.com/read/28381691/autoimmune-bullous-disease-and-hashimoto-s-disease-complicated-by-acquired-hemophilia-a
#3
Nobuko Nishiura, Daisuke Ujimoto, Jiro Fujita, Tetsuo Maeda, Yukinobu Nakagawa, Hirokazu Kashiwagi, Kenji Oritani, Yoshiaki Tomiyama, Yuzuru Kanakura
A 67-year-old man was admitted with a 1-month history of spontaneous hematoma in his right back and severe anemia. He had suffered from rashes with blisters involving both legs for 10 years, which had shown worsening and extended to his entire body concurrently with the hematoma. APTT was markedly prolonged to 119 seconds, and Factor VIII:C and FVIII inhibitor levels were less than 1% and 153.1 BU/ml, respectively, confirming the diagnosis of acquired hemophilia A (AHA). Skin biopsy revealed his rashes to be caused by autoimmune bullous disease (ABD), and laboratory and physical findings showed that he also had autoimmune hypothyroidism (Hashimoto's disease)...
2017: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
https://www.readbyqxmd.com/read/28360881/hemostasis-in-intracranial-hemorrhage
#4
REVIEW
Deepak Gulati, Dharti Dua, Michel T Torbey
Spontaneous non-traumatic intracerebral hemorrhage (ICH) is associated with high morbidity and mortality throughout the world with no proven effective treatment. Majority of hematoma expansion occur within 4 h after symptom onset and is associated with early deterioration and poor clinical outcome. There is a vital role of ultra-early hemostatic therapy in ICH to limit hematoma expansion. Patients at risk for hematoma expansion are with underlying hemostatic abnormalities. Treatment strategy should include appropriate intervention based on the history of use of antithrombotic use or an underlying coagulopathy in patients with ICH...
2017: Frontiers in Neurology
https://www.readbyqxmd.com/read/28223242/fviia-prevents-the-progressive-hemorrhaging-of-a-brain-contusion-by-protecting-microvessels-via-formation-of-the-tf-fviia-fxa-complex
#5
Qiang Yuan, Dalong Zhang, Sirong Wu, Jian Yu, Lei Yu, Yirui Sun, Zhuoying Du, Zhiqi Li, Liangfu Zhou, Xing Wu, Jin Hu
Factor VII (FVII) plays a key role in the initiation of the coagulation cascade and, in clinical situations, recombinant human activated FVII (rFVIIa) effectively prevents progressive hemorrhaging after a brain contusion. However, it remains unclear whether decreases in FVII activity directly lead to progressive hemorrhaging and, moreover, the precise mechanisms underlying this process are not yet known. The present study demonstrated that decreased FVII activity directly led to progressive hemorrhaging of the cerebral contusions...
February 20, 2017: Neuroscience
https://www.readbyqxmd.com/read/28219621/topical-application-of-recombinant-activated-factor-vii-during-cesarean-delivery-for-placenta-previa
#6
Birgit T B G Schjoldager, Emmeli Mikkelsen, Malene R Lykke, Jørgen Præst, Anne-Mette Hvas, Lars Heslet, Niels J Secher, Jannie D Salvig, Niels Uldbjerg
BACKGROUND: During cesarean delivery in patients with placenta previa, hemorrhaging after removal of the placenta is often challenging. In this condition, the extraordinarily high concentration of tissue factor at the placenta site may constitute a principle of treatment as it activates coagulation very effectively. The presumption, however, is that tissue factor is bound to activated factor VII. OBJECTIVE: We hypothesized that topical application of recombinant activated factor VII at the placenta site reduces bleeding without affecting intravascular coagulation...
February 20, 2017: American Journal of Obstetrics and Gynecology
https://www.readbyqxmd.com/read/27646211/the-tipping-point-the-critical-role-of-therapeutic-apheresis-in-a-case-of-refractory-acquired-hemophilia
#7
Michael Losos, Scott Scrape, Sarita Joshi, Aaron Shmookler, Jian Chen
Acquired hemophilia A (AHA) is a rare autoimmune disorder that leads to factor VIII (FVIII) deficiency via autoantibody formation. Standard treatment options include FVIII bypassing factors and immunosuppression. However, the role of therapeutic plasma exchange (TPE) is not clear in the treatment of AHA. We present a case of idiopathic AHA in a 66 year old female with severe bleeding and a FVIII inhibitor of 17.6 Bethesda units (BU). She failed to respond to standard treatment including maximum dose of recombinant FVIIa (rFVIIa), rituximab, and other immunosuppressive agents...
September 20, 2016: Journal of Clinical Apheresis
https://www.readbyqxmd.com/read/27501279/trust-trial-bay-86-6150-use-in-haemophilia-with-inhibitors-and-assessment-for-immunogenicity
#8
J Mahlangu, P Paz, M Hardtke, F Aswad, J Schroeder
INTRODUCTION: The most serious and challenging complication of haemophilia treatment is development of inhibitors to replacement factors VIII or IX. Innovative therapies currently being explored for patients with haemophilia and inhibitors include BAY 86-6150, a modified recombinant activated factor VII (FVIIa). Immunogenicity remains a substantial barrier in this endeavour. AIM: To present safety and efficacy results of the BAY 86-6150 study in patients with inhibitors and report detailed analysis of epitope mapping in a patient who developed anti-BAY 86-6150 antibodies...
November 2016: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/27423005/tissue-factor-expressed-by-adherent-cells-contributes-to-hemodialysis-membrane-thrombogenicity
#9
Souad Lakbakbi, Alexandre Debrumetz, Christine Terryn, Jean Szymezak, Philippe Rieu, Philippe Nguyen
End-stage renal patients present a high risk of thrombosis and bleeding. Consequently, it is challenging to prevent clotting during hemodialysis. If a contact system induces thrombin generation in the extra corporeal circuit, recent data suggest a role of tissue factor (TF) in hemodialysis-associated thrombosis. Using a method of elution, we collected adhering cells to an acrylonitrile membrane layered by polythyleneimine (AN69-ST). Using optic microscopy and flow cytometry, we observed that adherent cells were mainly constituted by activated polymorphonuclear neutrophils (PMNs)...
August 2016: Thrombosis Research
https://www.readbyqxmd.com/read/27248165/a-plasma-proteolysis-pathway-comprising-blood-coagulation-proteases
#10
Lu Yang, Yun Li, Arup Bhattacharya, Yuesheng Zhang
Coagulation factors are essential for hemostasis. Here, we show that these factors also team up to degrade plasma proteins that are unrelated to hemostasis. Prolidase, SRC and amyloid β1-42 (Aβ1-42) are used as probes. Each probe, upon entering the blood circulation, binds and activates factor XII (FXII), triggering the intrinsic and common coagulation cascades, which in turn activate factor VII, a component of the extrinsic coagulation cascade. Activated factor VII (FVIIa) rapidly degrades the circulating probes...
July 5, 2016: Oncotarget
https://www.readbyqxmd.com/read/27232114/safety-and-efficacy-of-recombinant-factor-viia-by-pediatric-age-cohort-reassessment-of-compassionate-use-and-trial-data-supporting-us-label
#11
Stacy E Croteau, Charles Nakar, Ellis J Neufeld, Amy Shapiro, David L Cooper
BACKGROUND: The relative safety and efficacy of recombinant activated coagulation factor VII (rFVIIa, NovoSeven® RT) across pediatric age cohorts is poorly defined. The objective of this analysis was to assess the safety and efficacy of rFVIIa in pediatric patients with congenital hemophilia with inhibitors (CHwI) in the clinical studies supporting the U.S. labeling. PROCEDURE: Pediatric data were derived from seven studies (five acute and two perioperative treatments) and pooled...
October 2016: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/27032741/management-of-labour-and-delivery-in-a-patient-with-acquired-factor-vii-deficiency-with-inhibitor-a-case-report
#12
Anca Matei, Sean Dolan, James Andrews, Georges-Étienne Rivard
BACKGROUND: Acquired factor VII (FVII) deficiency with inhibitor increases the risk of hemorrhage during pregnancy. However, there are no published reports guiding its management in the peripartum period. CASE: A 24-year-old woman with inhibitory antibodies to FVII delivered at 34 weeks of gestation. The patient was administered recombinant factor VIIa (rFVIIa) and tranexamic acid. There were no bleeding-related complications; however, the FVII level was supratherapeutic...
February 2016: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
https://www.readbyqxmd.com/read/26952654/an-activated-factor-vii-variant-with-enhanced-tissue-factor-independent-activity-speeds-wound-healing-in-a-mouse-hemophilia-b-model
#13
M Hoffman, J-Y Chang, M Ezban, D M Monroe
UNLABELLED: Essentials Disorders of hemostasis can lead to delayed and defective wound healing. In hemophilia B (HB) mice, 7 days of Factor (F)IX or VIIa are needed to normalize wound healing. One dose of a highly active FVIIa variant (DVQ) restored normal wound closure time in HB mice. Coagulation factors with enhanced activity may acquire biological effects not due to hemostasis. SUMMARY: Introduction We have previously reported that hemophilia B (HB) mice have delayed healing of cutaneous wounds and alterations in wound histology...
June 2016: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/26852649/heterozygous-congenital-factor-vii-deficiency-with-the-9729del4-mutation-associated-with-severe-spontaneous-intracranial-bleeding-in-an-adolescent-male
#14
Thomas J Cramer, Kristin Anderson, Karanjia Navaz, Justin M Brown, Laurent O Mosnier, Annette von Drygalski
BACKGROUND: In congenital Factor (F) VII deficiency bleeding phenotype and intrinsic FVII activity levels don't always correlate. Patients with FVII activity levels <30% appear to have a higher bleeding propensity, but bleeding can also occur at higher FVII activity levels. Reasons for bleeding at higher FVII activity levels are unknown, and it remains challenging to manage such patients clinically. CASE: A 19year old male with spontaneous intracranial hemorrhage and FVII activity levels of 44%, requiring emergent surgical intervention and a strategy for FVII replacement...
March 2016: Blood Cells, Molecules & Diseases
https://www.readbyqxmd.com/read/26797521/the-m358r-variant-of-%C3%AE-1-proteinase-inhibitor-inhibits-coagulation-factor-viia
#15
William P Sheffield, Varsha Bhakta
The naturally occurring M358R mutation of the plasma serpin α1-proteinase inhibitor (API) changes both its cleavable reactive centre bond to Arg-Ser and the efficacy with which it inhibits different proteases, reducing the rate of inhibition of neutrophil elastase, and enhancing that of thrombin, factor XIa, and kallikrein, by several orders of magnitude. Although another plasma serpin with an Arg-Ser reactive centre, antithrombin (AT), has been shown to inhibit factor VIIa (FVIIa), no published data are available with respect to FVIIa inhibition by API M358R...
February 12, 2016: Biochemical and Biophysical Research Communications
https://www.readbyqxmd.com/read/26637729/coagulopathy-in-liver-disease-a-balancing-act
#16
Jody L Kujovich
Liver disease results in complex alterations of all 3 phases of hemostasis. It is now recognized that hemostasis is rebalanced in chronic liver disease. The fall in clotting factor levels is accompanied by a parallel fall in anticoagulant proteins. High von Willebrand factor levels counteract defects in primary hemostasis. Conventional coagulation tests do not fully reflect the derangement in hemostasis and do not accurately predict the risk of bleeding. Global coagulation assays (thrombin generation, thromboelastography) reflect the interaction between procoagulant factors, anticoagulant factors, platelets, and the fibrinolytic system and show promise for assessing bleeding risk and guiding therapy...
2015: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/26362483/changes-in-the-amino-acid-sequence-of-the-recombinant-human-factor-viia-analog-vatreptacog-alfa-are-associated-with-clinical-immunogenicity
#17
RANDOMIZED CONTROLLED TRIAL
J N Mahlangu, K N Weldingh, S R Lentz, S Kaicker, F A Karim, T Matsushita, M Recht, W Tomczak, J Windyga, S Ehrenforth, K Knobe
BACKGROUND: Vatreptacog alfa, a recombinant human factor VIIa (rFVIIa) analog developed to improve the treatment of bleeds in hemophilia patients with inhibitors, differs from native FVIIa by three amino acid substitutions. In a randomized, double-blind, crossover, confirmatory phase III trial (adept(™) 2), 8/72 (11%) hemophilia A or B patients with inhibitors treated for acute bleeds developed anti-drug antibodies (ADAs) to vatreptacog alfa. OBJECTIVES: To characterize the formation of anti-vatreptacog alfa ADAs in hemophilia patients with inhibitors...
November 2015: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/26312163/using-a-systems-pharmacology-model-of-the-blood-coagulation-network-to-predict-the-effects-of-various-therapies-on-biomarkers
#18
S Nayak, D Lee, S Patel-Hett, D D Pittman, S W Martin, A C Heatherington, P Vicini, F Hua
A number of therapeutics have been developed or are under development aiming to modulate the coagulation network to treat various diseases. We used a systems model to better understand the effect of modulating various components on blood coagulation. A computational model of the coagulation network was built to match in-house in vitro thrombin generation and activated Partial Thromboplastin Time (aPTT) data with various concentrations of recombinant factor VIIa (FVIIa) or factor Xa added to normal human plasma or factor VIII-deficient plasma...
July 2015: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/26073369/recombinant-activated-factor-vii-in-the-treatment-of-bleeds-and-for-the-prevention-of-surgery-related-bleeding-in-congenital-haemophilia-with-inhibitors
#19
REVIEW
Elena Santagostino, Miguel Escobar, Margareth Ozelo, Luigi Solimeno, Per Arkhammar, Hye Youn Lee, Gabriela Rosu, Paul Giangrande
The availability of recombinant activated factor VII (rFVIIa, eptacog alfa activated) has greatly advanced the care of patients with haemophilia A or B who have developed inhibitors against the infused replacement factor. Recombinant FVIIa is licensed for the on-demand treatment of bleeding episodes and the prevention of bleeding in surgery or invasive procedures in patients with congenital haemophilia with inhibitors. This article attempts to review in detail the extensive evidence of rFVIIa in congenital haemophilia patients with inhibitors...
June 2015: Blood Reviews
https://www.readbyqxmd.com/read/26073368/recombinant-activated-factor-vii-30-years-of-research-and-innovation
#20
REVIEW
Ulla Hedner
Recombinant activated factor VII (rFVIIa) was initially developed to treat bleeding episodes in patients with congenital haemophilia and inhibitors. The story of its development began in the 1970s, when FVIIa was identified as one of the activated coagulation factors that has minimal potential for inducing thromboembolic side-effects. Extensive research over the last 30 years has greatly increased our knowledge of the characteristics of FVII, its activation, and the mechanisms by which rFVIIa restores haemostasis...
June 2015: Blood Reviews
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