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https://www.readbyqxmd.com/read/29888855/in-vitro-studies-show-synergistic-effects-of-a-procoagulant-bispecific-antibody-and-bypassing-agents
#1
R Hartmann, T Feenstra, L Valentino, M Dockal, F Scheiflinger
BACKGROUND: Investigational non-factor products such as emicizumab offer a treatment option for patients with hemophilia and inhibitors. However, their mechanism of action raises questions regarding safety when combined with treatments for breakthrough bleeding. OBJECTIVES: Evaluate in vitro thrombin generation (TG) and clot formation for combinations of activated prothrombin complex concentrate (aPCC), recombinant activated clotting factor VII (rFVIIa), and a sequence-identical analog of emicizumab (SIA)...
June 11, 2018: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/29884513/acquired-antibodies-to-%C3%AE-iib%C3%AE-3-in-glanzmann-thrombasthenia-from-transfusion-and-pregnancy-to-bone-marrow-transplants-and-beyond
#2
REVIEW
Alan T Nurden
Patients with the inherited bleeding disorder Glanzmann thrombasthenia (GT) possess platelets that lack αIIbβ3 integrin and fail to aggregate, and have moderate to severe mucocutaneous bleeding. Many become refractory to platelet transfusions due to the formation of isoantibodies to αIIbβ3 with the rapid elimination of donor platelets and/or a block of function. Epitope characterization has shown isoantibodies to be polyclonal and to recognize different epitopes on the integrin with β3 a major site and αvβ3 on endothelial and vascular cells a newly recognized target...
May 23, 2018: Transfusion Medicine Reviews
https://www.readbyqxmd.com/read/29804265/lessons-from-a-systematic-literature-review-of-the-effectiveness-of-recombinant-factor-viia-in-acquired-haemophilia
#3
Andreas Tiede, Andrew Worster
To conduct a systematic review of the literature reporting efficacy and safety of recombinant factor VIIa (rFVIIa) for the treatment of bleeding in acquired haemophilia and, if data permitted, undertake a meta-analysis of the current evidence. MEDLINE® , Embase® , and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched for all studies on rFVIIa treatment in acquired haemophilia. Heterogeneity of included studies was measured using the inconsistency index (I2 ). Of the 2353 publications screened, 290 potentially relevant references were identified: 12 studies published in 32 publications met inclusion criteria...
May 26, 2018: Annals of Hematology
https://www.readbyqxmd.com/read/29766126/factor-viia-administration-in-traumatic-brain-injury-an-aast-mitc-propensity-score-analysis
#4
Sarah Lombardo, D Millar, Gregory J Jurkovich, Raul Coimbra, Ram Nirula
Background: Recombinant factor VIIa (rFVIIa) has been used off-label as an adjunct in the reversal of warfarin therapy and management of hemorrhage after trauma. Only a handful of these reports are rigorous studies, from which results regarding safety and effectiveness have been mixed. There remains no clear consensus as to the role of rFVIIa in traumatic brain injury (TBI). Methods: Eleven level 1 trauma centers provided clinical data and head CT scans of patients with a Glasgow Coma Scale (GCS) score of ≤13 and radiographic evidence of TBI...
2018: Trauma surgery & acute care open
https://www.readbyqxmd.com/read/29765293/recurrent-bleedings-in-newborn-a-factor-vii-deficiency-case-report
#5
Kim Cattivelli, Cristina Distefano, Lorenza Bonetti, Sophie Testa, Simona Maria Siboni, Alessandro Plebani, Carlo Poggiani
Background: Major hemorrhages in newborns can be caused by several conditions, and knowledge of the differential diagnosis is essential in order to ensure prompt recognition and appropriate treatment. Case Report: We describe the case of a male newborn experiencing recurrent hemorrhages from the first days of life. Laboratory findings showed normal platelet count, hepatic function, and C-reactive protein. Coagulation tests detected an isolated prothrombin time (PT) prolongation and severe factor VII (FVII) deficiency...
April 2018: Transfusion Medicine and Hemotherapy
https://www.readbyqxmd.com/read/29758126/abrogating-fibrinolysis-does-not-improve-bleeding-or-rfviia-rfviii-treatment-in-a-non-mucosal-venous-injury-model-in-haemophilic-rodents
#6
Rikke Stagaard, Matthew J Flick, Barbara Bojko, Krzysztof Goryński, Paulina Z Goryńska, Carsten D Ley, Lisbeth H Olsen, Tom Knudsen
BACKGROUND: Fibrinolysis may exacerbate bleeding in haemophilia A (HA). Accordingly, antifibrinolytics have been used to help maintain haemostatic control. While antifibrinolytic drugs have been proven effective in the treatment of mucosal bleeds in the oral cavity, their efficacy in non-mucosal tissues remain an open question of significant clinical interest. OBJECTIVE: To determine whether inhibiting fibrinolysis improves the outcome in non-mucosal haemophilic tail vein transection (TVT) bleeding models, and to determine whether a standard ex vivo clotting/fibrinolysis assay can be used as a predictive surrogate for in vivo efficacy...
May 14, 2018: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/29757137/reversal-of-apixaban-induced-alterations-in-haemostasis-by-different-coagulation-factor-concentrates-in-patients-after-hip-or-knee-replacement-surgery
#7
Katrin Schmidt, Kerstin Krüger, Elisabeth Langer, Martin Schmutzler, Elke Johnen, Klaus D Wernecke, Christian Von Heymann, Mareike K Körber
BACKGROUND: Apixaban is a direct oral anticoagulant (DOAC) with a specific inhibition of activated factor X (FXa). In case of bleeding or need of urgent surgery a direct antidote is not yet available. Off-label application of non-specific haemostatic agents, such as prothrombin complex concentrate (PCC) and recombinant FVIIa (rFVIIa), has been reported to reverse the effects of apixaban in in vitro and animal studies. The aim of this study is to measure the reversal potential of PCC and rFVIIa in patients with prophylactic apixaban concentrations...
May 11, 2018: Blood Transfusion, Trasfusione del Sangue
https://www.readbyqxmd.com/read/29750671/successful-treatment-of-severe-menorrhagia-at-menarche-with-recombinant-factor-viia-in-an-adolescent-girl-with-type-iii-von-willebrand-s-disease
#8
Dilek Gurlek Gokcebay, Vildan Culha, Nese Yarali, Namik Yasar Ozbek
: Type III von Willebrand's disease (vWD) is an inherited bleeding disorder, which is frequently associated with menorrhagia in women. Treatment options include antifibrinolytics, desmopressin, von Willebrand factor/factor VIII concentrates and in intractable bleeding circumstances recombinant factor VIIa (rFVIIa). We present an adolescent case with type III vWD who had a menorrhagia at menarche that was refractory to the standard treatment and ultimately was treated with rFVIIa successfully.
May 9, 2018: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
https://www.readbyqxmd.com/read/29741299/methodologies-for-data-collection-in-congenital-haemophilia-with-inhibitors-chwi-critical-assessment-of-the-literature-and-lessons-learned-from-recombinant-factor-viia
#9
REVIEW
C M Kessler, S Benchikh El Fegoun, A Worster
AIMS: To systematically review the effectiveness of on-demand treatment with recombinant coagulation factor VIIa (rFVIIa) in congenital haemophilia with inhibitors and, if feasible, perform a meta-analysis of the data. MATERIALS AND METHODS: Publications from Embase® , MEDLINE® , MEDLINE® In-Process and the Cochrane Central Register of Controlled Trials were searched. Selected publications were reviewed for inclusion by two independent expert reviewers. Discrepancies were reconciled by a third independent reviewer...
May 9, 2018: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/29724628/the-rare-coexistence-of-high-titer-inhibitor-development-and-gastrointestinal-stromal-tumor-in-a-patient-with-severe-hemophilia-a-case-report
#10
Abdulkerim Yıldız, Osman Şahin, Okan Yayar, Çiğdem Pala Öztürk, Hacer Berna Afacan Öztürk, Senem Maral, Harika Okutan, Murat Albayrak
Hemophilia is a hereditary disease with impaired blood coagulation due to a genetic deficiency of blood coagulation factors. The development of inhibitors further complicates the course of the disease and management. The case is here reported of a haemophilia patient who presented with coexisting development of high titer inhibitor with Gastrointestinal Stromal Tumor (GIST) diagnosis and was admitted with upper gastrointestinal system bleeding. The patient had no prior history of inhibitor presence. During all procedures including surgery, excellent hemostasis was achieved with rFVIIa treatment and no hemorrhagic complication was observed...
April 26, 2018: Transfusion and Apheresis Science
https://www.readbyqxmd.com/read/29723892/treatment-regimens-with-bypassing-agents-in-patients-with-hemophilia-a-and-inhibitors-a-survey-from-the-italian-association-of-hemophilia-centers-aice
#11
Antonio Coppola, Massimo Franchini, Giancarlo Castaman, Elena Santagostino, Cristina Santoro, Rita Carlotta Santoro, Massimo Morfini, Giovanni Di Minno, Angiola Rocino
The development of neutralizing antibodies (inhibitors) against infused factor VIII currently represents the main complication of replacement therapy in patients with severe hemophilia A. Inhibitors, indeed, particularly high-titer inhibitors (>5 BU/mL), greatly complicate the management of bleeding, exposing patients to an increased morbidity and mortality risk, thus representing a significant burden for physicians of Hemophilia Treatment Centers (HTCs). Although bypassing agents (i.e., activated prothrombin complex concentrate [APCC] and recombinant activated factor VII [rFVIIa]) are available for the treatment and prevention of bleeding in inhibitor patients, their efficacy, safety, and cost-benefit outcomes are poorly known in the long term and should be further improved...
May 3, 2018: Seminars in Thrombosis and Hemostasis
https://www.readbyqxmd.com/read/29703489/mechanisms-and-management-of-coagulopathy-in-acute-promyelocytic-leukemia
#12
Sachin David, Vikram Mathews
Acute promyelocytic leukemia (APL) is a subtype of leukemia which is associated with unique and distinctive coagulopathy. In the absence of treatment it is rapidly fatal and even after initiation of therapy the major cause of early mortality is related to hemorrhagic complications. The coagulopathy can be exacerbated with the start of treatment. In the absence of early hemorrhage related deaths the probability of cure exceeds 90% in low and intermediate risk patients and 80% even in high risk patients, highlighting the importance of understanding the pathophysiology of this complication and instituting prompt and appropriate management strategies...
April 2018: Thrombosis Research
https://www.readbyqxmd.com/read/29669438/standardized-management-protocol-in-severe-postpartum-hemorrhage-a-single-center-study
#13
Giuseppe Colucci, Karin Helsing, Franziska Demarmels Biasiutti, Luigi Raio, Pirmin Schmid, Dimitrios A Tsakiris, Balthasar Eberle, Daniel Surbek, Bernhard Lämmle, Lorenzo Alberio
Severe postpartum hemorrhage (sPPH) is an obstetric emergency that needs prompt and effective therapy to reduce the risk of complications. In this study, women who developed sPPH (study cohort, n = 27) were treated according to a standardized management protocol prescribing sequential administration of uterotonic drugs, crystalloids, tranexamic acid, labile blood products, low-dose fibrinogen, and recombinant activated factor VII (rFVIIa). This group was compared to patients treated with different strategies during 2 preceding periods: an in-house guideline regulating the administration of rFVIIa (historical cohort 1, n = 20) and no specific guideline (historical cohort 2, n = 27)...
January 1, 2018: Clinical and Applied Thrombosis/hemostasis
https://www.readbyqxmd.com/read/29611182/factor-f-viii-viia-enhances-global-haemostatic-function-in-the-co-presence-of-bypassing-agents-and-fviii-among-patients-with-haemophilia-a-with-inhibitor
#14
Keiji Nogami, Tomoko Matsumoto, Koji Yada, Kenichi Ogiwara, Shoko Furukawa, Yasuaki Shida, Masahiro Takeyama, Midori Shima
Bypassing therapy is essential for the haemostatic management of patients with haemophilia A with inhibitor (PWHA-inh), but the therapeutic effects are inconsistent. We previously reported that activated prothrombin complex concentrates (aPCC) activated factor (F)VIIIin vitro, and was mediated mainly by the activated FVII (FVIIa) contained in aPCC. We have extended those studies to assess global coagulation in whole blood from 18 PWHA-inh in the co-presence of aPCC and FVIII using Ca2+ -triggered rotational thromboelastometry...
May 2018: British Journal of Haematology
https://www.readbyqxmd.com/read/29566162/recombinant-activated-factor-vii-is-associated-with-postoperative-thromboembolic-adverse-events-in-bleeding-after-coronary-surgery
#15
Aly Makram Habib, Antonio Maria Calafiore, Marco Cargoni, Massimiliano Foschi, Michele Di Mauro
OBJECTIVES: To evaluate the impact of recombinant activated factor VII (rFVIIa) administration on thromboembolic adverse events (TAEs) in coronary artery bypass grafting (CABG) surgery patients showing postoperative bleeding. METHODS: From January 2004 to May 2015, 180 CABG surgery patients with postoperative bleeding were included in the study. All patients were managed conservatively and 81 (45%) also received rFVIIa. RESULTS: Ten patients developed new TAEs (5...
March 16, 2018: Interactive Cardiovascular and Thoracic Surgery
https://www.readbyqxmd.com/read/29537116/in-vitro-characterization-of-mod-5014-a-novel-long-acting-carboxy-terminal-peptide-ctp-modified-activated-fvii
#16
A Bar-Ilan, T Livnat, M Hoffmann, L Binder, M Zakar, R Guy, Y Felikman, L Moschcovich, B Shenkman, D Monroe, O Hershkovitz, G Kenet, G Hart
INTRODUCTION: Recombinant FVIIa (rFVIIa) is an effective treatment for haemophilia through frequent administration. However, the short half-life of rFVIIa decreases its prophylactic ability to reduce bleeding. Carboxy-terminal peptide (CTP)-modified FVIIa (MOD-5014) is a long-acting rFVIIa developed for on-demand treatment of haemophilia using either an intravenous or subcutaneous injection with the aim of less frequent administrations, as well as for prophylactic use. AIM: The comprehensive evaluation of the activity MOD-5014 vs commercially available rhFVIIa, as well as their interaction with cofactors and inhibitors...
March 14, 2018: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/29508176/factor-viia-administration-in-orthotopic-heart-transplant-recipients-and-its-impact-on-thromboembolic-events-and-post-transplant-outcomes
#17
Ryan J Winstead, Komal Pandya, Jeremy Flynn, George A Davis, Adam Sieg, Maya Guglin, Aric Schadler, Rickey A Evans
Recombinant, activated factor VIIa (rFVIIa) is used during cardiac surgeries to mitigate refractory coagulopathic bleeding. The purpose of this study was to examine whether rFVIIa use in orthotopic heart transplant (OHT) recipients was associated with a higher incidence of thromboembolic (TE) events compared to patients who did not. A single-center, retrospective, cohort study was performed on OHT recipients who received rFVIIa for refractory coagulopathic bleeding from January 2013 to December 2015. Patients were evaluated for up to 6 months after transplantation and assessed for TE events, rejection, readmissions, graft survival, and patient survival...
April 2018: Journal of Thrombosis and Thrombolysis
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
#18
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...
March 30, 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
#19
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...
May 2018: American Journal of Surgery
https://www.readbyqxmd.com/read/29351237/bioengineering-of-rfviia-biopharmaceutical-and-structure-characterization-for-biosimilarity-assessment
#20
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
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