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https://www.readbyqxmd.com/read/28319507/recombinant-factor-viia-is-associated-with-increased-thrombotic-complications-in-pediatric-cardiac-surgery-patients
#1
Laura Downey, Morgan L Brown, David Faraoni, David Zurakowski, James A DiNardo
BACKGROUND: Recombinant factor VIIa (rFVIIa) is routinely used as an off-label hemostatic agent in children undergoing cardiac surgery. Despite evidence that rFVIIa use is associated with an increased incidence of thrombotic complications in adult cardiac surgery, the safety of rFVIIa as a rescue hemostatic agent in the pediatric cardiac surgical population is less definitively delineated. In this retrospective study, we used propensity score matching to compare the incidence of thrombotic complications between children treated with rFVIIa and their matched controls...
March 17, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28255432/response-to-treatment-and-adverse-events-associated-with-use-of-recombinant-activated-factor-vii-in-children-a-retrospective-cohort-study
#2
James D Cooper, Arthur K Ritchey
BACKGROUND: Recombinant activated factor VII (rFVIIa) is United States (US) Food and Drug Administration (FDA)-approved for patients with hemophilia with inhibitors or congenital factor VII deficiency. Initial reports of off-label use highlighted its efficacy, though newer reports have not repeated these findings. In both types of publication, though, secondary thromboses have been seen in adult patients. The data in children are less clear. METHODS: This study analyzed all rFVIIa use at a large children's hospital for characteristics and outcomes...
February 2017: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/28239301/the-reversal-effect-of-prothrombin-complex-concentrate-pcc-activated-pcc-and-recombinant-activated-factor-vii-against-anticoagulation-of-xa-inhibitor
#3
Nina Haagenrud Schultz, Hoa Thi Tuyet Tran, Stine Bjørnsen, Carola Elisabeth Henriksson, Per Morten Sandset, Pål Andre Holme
BACKGROUND: An increasing number of patients are treated with direct-acting oral anticoagulants (DOACs), but the optimal way to reverse the anticoagulant effect is not known. Specific antidotes are not available and prothrombin complex concentrate (PCC), activated PCC (aPCC) and recombinant factor VIIa (rFVIIa) are variously used as reversal agents in case of a major bleeding. We aimed to determine the most effective haemostatic agent and dose to reverse the effect of rivaroxaban in blood samples from patients taking rivaroxaban for therapeutic reasons...
2017: Thrombosis Journal
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
#4
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-section-for-placenta-previa
#5
Birgit Tbg 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 principal of treatment as it activates coagulation very effectively. The presumption, however, is that tissue factor is bound to activated factor VII (FVIIa). OBJECTIVE: We hypothesized that topical application of recombinant FVIIa (rFVIIa) at the placenta site reduces the bleeding without affecting the intravascular coagulation...
February 17, 2017: American Journal of Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28159767/ticagrelor-reversal-in-vitro-assessment-of-four-haemostatic-agents
#6
Leyla Calmette, Anne-Céline Martin, Bernard Le Bonniec, Diane Zlotnik, Isabelle Gouin-Thibault, Christilla Bachelot-Loza, Pascale Gaussem, Anne Godier
AIM: Management of ticagrelor-induced bleeding is challenging as platelet transfusion is ineffective. An effective strategy is needed. This study aimed to investigate in vitro the efficacy of four haemostatic drugs (HDs), namely recombinant activated factor VII (rFVIIa), fibrinogen concentrate (Fib), tranexamic acid (TXA) and factor XIII concentrate (FXIII) to improve the haemostatic capacity in the presence of ticagrelor. METHODS: Blood was spiked with ticagrelor then supplemented by either HD or control...
February 3, 2017: Journal of Clinical Pathology
https://www.readbyqxmd.com/read/28077675/post-hoc-assessment-of-the-immunogenicity-of-bioengineered-factor-viia-demonstrates-the-use-of-preclinical-tools
#7
Kasper Lamberth, Stine Louise Reedtz-Runge, Jonathan Simon, Ksenia Klementyeva, Gouri Shankar Pandey, Søren Berg Padkjær, Véronique Pascal, Ileana R León, Charlotte Nini Gudme, Søren Buus, Zuben E Sauna
Immunogenicity is an important consideration in the licensure of a therapeutic protein because the development of neutralizing anti-drug antibodies (ADAs) can affect both safety and efficacy. Neoantigens introduced by bioengineering of a protein drug are a particular cause for concern. The development of a bioengineered recombinant factor VIIa (rFVIIa) analog was discontinued after phase 3 trials because of the development of ADAs. The unmodified parent molecule (rFVIIa), on the other hand, has been successfully used as a drug for more than two decades with no reports of immunogenicity in congenital hemophilia patients with inhibitors...
January 11, 2017: Science Translational Medicine
https://www.readbyqxmd.com/read/28077534/reduced-mortality-by-meeting-guideline-criteria-before-using-recombinant-activated-factor-vii-in-severe-trauma-patients-with-massive-bleeding
#8
J-F Payen, M Berthet, C Genty, P Declety, D Garrigue-Huet, N Morel, P Bouzat, B Riou, J-L Bosson
BACKGROUND: Management of trauma patients with severe bleeding has led to criteria before considering use of recombinant activated factor VII (rFVIIa), including haemoglobin >8 g dl(-1), serum fibrinogen ≥1.0 g l(-1), platelets >50,000 x 10(9) l(-1), arterial pH ≥ 7.20, and body temperature ≥34 °C. We hypothesized that meeting these criteria is associated with improved outcomes. METHODS: In this prospective cohort study of 26 French trauma centres, subjects were included if they received rFVIIa for persistent massive bleeding despite appropriate care after severe blunt and/or penetrating trauma...
October 2016: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/28038846/primary-prophylaxis-for-children-with-severe-congenital-factor-vii-deficiency-clinical-and-laboratory-assessment
#9
A A Kuperman, A A Barg, Y Fruchtman, E Shaoul, N Rosenberg, G Kenet, T Livnat
Severe congenital factor VII (FVII) deficiency is a rare bleeding disorder. Prophylaxis with replacement therapy has been suggested to patients, yet the most beneficial dosing regimens and therapy intervals are still to be defined. Due to the lack of evidence-based data, we hereby present our experience with long-term administration and monitoring primary prophylaxis in children with severe FVII deficiency and an extremely high bleeding risk. Four children with familial FVII deficiency, treated by prophylactic recombinant activated factor VII (rFVIIa), 15-30μg/kg/dose, given 2-3 times weekly since infancy, are discussed...
December 19, 2016: Blood Cells, Molecules & Diseases
https://www.readbyqxmd.com/read/28034354/recombinant-activated-factor-vii-eptacog-alfa-activated-novoseven-%C3%A2-in-patients-with-rare-congenital-bleeding-disorders-a-systematic-review-on-its-use-in-surgical-procedures
#10
Matteo Nicola Dario Di Minno, Pasquale Ambrosino, Veronika A Myasoedova, Manuela Amato, Itala Ventre, Elena Tremoli, Alessandro Di Minno
In the absence of definite guidelines in the area, we have carried a systemic review to provide a thorough overview concerning the efficacy and safety of recombinant activated factor VII (rFVIIa, NovoSeven®, Novo Nordisk A/S, Bagsværd, Denmark) in patients with Glanzmann's thrombasthenia (GT) and FVII deficiency, undergoing surgical procedures. PubMed, Web of Science, Scopus and EMBASE databases was employed for the search. Three multicenter registries were identified: the Glanzmann's Thrombasthenia Registry (GTR), the Seven Treatment Evaluation Registry (STER), and a German post-marketing surveillance registry (the WIRK study)...
December 30, 2016: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28026073/use-of-the-ukhcdo-database-for-a-postmarketing-surveillance-study-of-different-doses-of-recombinant-factor-viia-in-haemophilia
#11
C R M Hay, T Sharpe, G Dolan
INTRODUCTION: Recombinant factor VIIa (rFVIIa) is recommended in Europe at standard (3 × 90 μg kg(-1) ) or high (1 × 270 μg kg(-1) ) doses. When granting the license for the high dose, the European Medicines Agency (EMA) requested postmarketing surveillance for thrombosis. This was conducted by the United Kingdom National Haemophilia Database (NHD) on behalf of Novo Nordisk and the EMA. AIM: To assess the use and safety of rFVIIa utilizing prospective data collected by the NHD (1 January 2008 to 30 June 2011)...
December 27, 2016: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28018685/coexistence-of-factor-vii-deficiency-and-hereditary-spastic-paraplegia-in-two-siblings
#12
Hortensia De la Corte-Rodriguez, E Carlos Rodriguez-Merchan, M Teresa Alvarez-Roman, Ana L Hernandez-Moreno
We present the case of two patients aged 12 years and 7 years who were referred to our hospital for factor VII deficiency inherited in an autosomal recessive pattern, who had suffered from previous multiple joint haemarthroses. They presented with fine motor symptoms and difficulty in walking. During physical examination we observed neurological symptoms (general hypotonia, muscular hypotrophy, exaggerated tendon reflexes, pes cavus, and spastic gait). Given that the symptoms were not justified by the deficiency of coagulation factor VII and on suspicion of hereditary spastic paraplegia (HSP), tests were carried out...
2016: Case Reports in Hematology
https://www.readbyqxmd.com/read/27885231/two-elderly-patients-with-difficult-to-treat-acquired-hemophilia-a
#13
Makoto Saito, Masanobu Morioka
We herein report the cases of two elderly patients with acquired hemophilia A (AHA) for whom treatment was difficult.An 89-year-old woman (Case 1) was admitted to our department with subcutaneous hemorrhage and melena. Her activated partial thromboplastin time (APTT), factor VIII activity, and factor VIII inhibitor level were 127.7 seconds, 1.0%, and 48 BU/mL, respectively, which was suggestive of AHA. The administration of prednisolone (PSL 0.5 mg/kg) was initiated. After 3 weeks, PSL was combined with cyclophosphamide (CPA 50 mg)...
2016: Nihon Ronen Igakkai Zasshi. Japanese Journal of Geriatrics
https://www.readbyqxmd.com/read/27843336/treatment-of-bleeding-in-acquired-hemophilia-a-with-the-proper-administration-of-recombinant-activated-factor-vii-single-center-study-of-7-cases
#14
Makoto Saito, Minoru Kanaya, Koh Izumiyama, Akio Mori, Tatsuro Irie, Masanori Tanaka, Masanobu Morioka, Masahiro Ieko
Recombinant activated factor VII (rFVIIa) is the bypassing agent used in the first-line hemostatic therapy for acquired hemophilia A (AHA); however, the occurrence of thrombotic complications in rFVIIa-treated AHA patients was recently reported to be 2.9-6.5%. Therefore, the investigation of the proper administration of rFVIIa for AHA is needed. In the present study, we retrospectively investigated the clinical features of AHA with regards to the use of rFVIIa (presence or absence of use and total amount) in 7 AHA patients encountered in our department for 7 years between January 2008 and December 2014...
2016: International Journal of General Medicine
https://www.readbyqxmd.com/read/27826851/recombinant-activated-factor-viia-rfviia-treatment-in-very-low-birth-weight-vlbw-premature-infants-with-acute-pulmonary-hemorrhage-a-single-center-retrospective-study
#15
Hese Cosar, Halil Isik, Salih Cagrı Cakır, Nese Yar, Bulent Goksen, Hakan Tokbay, Hasan Kertmen, Nihal Erdoğan, Ikbal Durak
AIM: We aimed to evaluate the efficacy of intravenous administration of recombinant activated factor VIIa (rFVIIa) for acute pulmonary hemorrhage treatment in very-low-birth-weight (VLBW) premature infants. PATIENTS AND METHODS: This study was carried out retrospectively in premature infants with pulmonary hemorrhage that were ≤30 weeks gestational age or <1250 g birth weight. The data of all VLBW premature infants with pulmonary hemorrhage who were hospitalized in our neonatal intensive care unit between 01 January 2013 and 31 December 2015 were evaluated...
February 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/27819553/pt-vwd-posing-diagnostic-and-therapeutic-challenges-small-case-series
#16
Analía Sánchez-Luceros, Adriana I Woods, Emilse Bermejo, Shilpa Shukla, Suchitra Acharya, Michelle Lavin, Natalia Rydz, Maha Othman
Despite the increased worldwide awareness, over the last decade, of the platelet-type von Willebrand Disease (PT-VWD), many uncertainties remain around this rare platelet bleeding disorder. This report aims to correctly identify and study the phenotype of new patients and highlights the diagnostic and therapeutic challenges this disease remains to pose. We describe four PT-VWD cases confirmed by genetic analysis in which either the diagnosis and/or the treatment posed challenge. We provide the details of the clinical presentation, laboratory analysis, and the treatment and the responses in each case...
November 7, 2016: Platelets
https://www.readbyqxmd.com/read/27797129/alternative-agents-to-prophylactic-platelet-transfusion-for-preventing-bleeding-in-people-with-thrombocytopenia-due-to-chronic-bone-marrow-failure-a-meta-analysis-and-systematic-review
#17
REVIEW
Michael Desborough, Andreas V Hadjinicolaou, Anna Chaimani, Marialena Trivella, Paresh Vyas, Carolyn Doree, Sally Hopewell, Simon J Stanworth, Lise J Estcourt
BACKGROUND: People with thrombocytopenia due to bone marrow failure are vulnerable to bleeding. Platelet transfusions have limited efficacy in this setting and alternative agents that could replace, or reduce platelet transfusion, and are effective at reducing bleeding are needed. OBJECTIVES: To compare the relative efficacy of different interventions for patients with thrombocytopenia due to chronic bone marrow failure and to derive a hierarchy of potential alternative treatments to platelet transfusions...
October 31, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27699729/the-management-of-factor-xi-deficiency-in-pregnancy
#18
REVIEW
Joanna Davies, Rezan Kadir
Management of factor XI (FXI) deficiency in pregnancy is complicated by lack of correlation between FXI level and bleeding risk. Clinicians should be vigilant about the potential for prolonged or excessive bleeding following miscarriage or termination of pregnancy, or postpartum hemorrhage (PPH). A multidisciplinary approach along with an individual care plan is recommended to prevent bleeding complications. Assessment of bleeding history, FXI level, and global tests of hemostasis can aid management decisions regarding hemostatic prophylaxis...
October 2016: Seminars in Thrombosis and Hemostasis
https://www.readbyqxmd.com/read/27696190/successful-management-of-perioperative-hemostasis-in-a-patient-with-glanzmann-thrombasthenia-who-underwent-a-right-total-mastectomy
#19
Yoshiyuki Ogawa, Shinji Kunishima, Kunio Yanagisawa, Yohei Osaki, Yuri Uchiyama, Naomichi Matsumoto, Hideaki Tokiniwa, Jun Horiguchi, Yoshihisa Nojima, Hiroshi Handa
Perioperative hemostatic management is a challenge in patients with Glanzmann thrombasthenia (GT). The standard means of preventing surgical bleeding in GT patients is platelet transfusion. However, GT patients often possess alloantibodies against GPIIb/IIIa and/or HLA, which cause resistance to platelet transfusion. HLA-matched platelet transfusion, plasmapheresis, or recombinant human-activated factor VII (rFVIIa) are alternative interventions in such cases. Monitoring of hemostasis is also critical in the management of GT patients who undergo surgery...
October 1, 2016: International Journal of Hematology
https://www.readbyqxmd.com/read/27688669/recombinant-activated-factor-vii-for-uncontrolled-bleeding-postcardiac-surgery
#20
Aly Makram Habib, Ahmed Yehia Mousa, Zohair Al-Halees
UNLABELLED: A retrospective observational study to review the safety and efficacy of rFVIIa in persistent hemorrhage in post cardiac surgical patients. METHODS: Patients who had bleeding of 3 ml/kg/h or more for 2 consecutive hours after cardiac surgery were arranged into two groups; control group, who received conventional treatment and rFVIIa group, who received conventional treatment and rFVIIa. RESULTS: There was no significant difference in demographic and surgical characteristics of both groups...
October 2016: Journal of the Saudi Heart Association
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