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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 3, 2016: Seminars in Thrombosis and Hemostasis
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
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
Aly Makram Habib
AIM OF THE STUDY: A retrospective observational study to compare safety and efficacy of high and low doses of recombinant activated factor VIIa (rFVIIa) in severe postcardiac surgical bleeding. PATIENTS AND METHODS: From 2004 to 2014, all patients who received rFVIIa for bleeding after cardiac surgery were included and arranged in two groups; Group 1: Low dose (40-50 mcg/kg) (n = 98) and Group 2: High dose (90-120 mcg/kg) (n = 156). RESULTS: There was no significant difference in demographic and surgical characteristics of both groups on admission to Cardiac Surgical Intensive Care Unit (CSICU)...
September 2016: Indian Journal of Critical Care Medicine
D Lee, S Nayak, S W Martin, A C Heatherington, P Vicini, F Hua
BACKGROUND: Prothrombin fragment 1.2 (PF12), thrombin-anti-thrombin III complex (TAT) and D-dimer can be detected in plasma from non-bleeding hemostatic normal or hemophilia subjects. They are often used as safety or pharmacodynamic biomarkers for hemostatic modulating therapies in clinic and provide insights into in vivo coagulation activity. OBJECTIVES: To develop a Quantitative Systems Pharmacology (QSP) model of blood coagulation network to describe in vivo biomarkers including PF12, TAT and D-dimer under non-bleeding condition...
September 26, 2016: Journal of Thrombosis and Haemostasis: JTH
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
Mina Golestani, Peyman Eshghi, Hamid Reza Rasekh, Abdoll Majid Cheraghali, Jamshid Salamzadeh, Majid Naderi, Mohammad Reza Managhchi, Hamid Hoorfar, Gholam Reza Toogeh, Ali Imani, Mohammad Taghi Khodayari, Behnaz Habibpanah, Razieh Hantooshzadeh
Nowadays, bypassing agents such as recombinant activated factor VII (rFVIIa) and activated prothrombin complex concentrates (aPCC) are used to treat bleeding episodes in the Hemophilia patients with inhibitors. AryoSeven® is an Iranian biogeneric rFVIIa with homogeneity of efficacy and the nature to NovoSeven in a comparative trial. The current clinical trial aimed to evaluate the cost-effectiveness of FEIBA and AryoSeven® by Decision Analytic Model according to the Iranian healthcare system. An open label, multi-center, cross-over clinical trial was designed...
2016: Iranian Journal of Pharmaceutical Research: IJPR
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...
September 13, 2016: British Journal of Anaesthesia
Pv-H Botianu, R Chirtes, C Marcu, H Kosza, M Stoian, O Brusnic, Amv Botianu, A Dobre
We report a 60 years old patient who was admitted for a local recurrence after a right nephrectomy performed 2 years ago (papillary renal carcinoma with areas of sarcomatoid differentiation - pT3a). CT scan showed a retroperitoneal mass with invasion of the inferior vena cava. We performed a complete en-bloque excision of the tumor with the infrarenal portion of the inferior vena cava and lympha-denectomy. The vascular reconstruction was performed by the interposition of a 20 mm diameter Dacron prosthesis. The postoperative course was complicated due to an episode of digestive bleeding (duodenal ulcer) which stopped after conservative treatment (antisecretory and hemostatics, including rFVIIa), but eventually favourable...
July 2016: Chirurgia
Y E Chee, S E Liu, M G Irwin
Management of acute coagulopathy and blood loss during major vascular procedures poses a significant haemostatic challenge to anaesthetists. The acute coagulopathy is multifactorial in origin with tissue injury and hypotension as the precipitating factors, followed by dilution, hypothermia, acidemia, hyperfibrinolysis and systemic inflammatory response, all acting as a self-perpetuating spiral of events. The problem is confounded by the high prevalence of antithrombotic agent use in these patients and intraoperative heparin administration...
September 2016: British Journal of Anaesthesia
Nasiredin Sadeghi, Massimo Iacobelli, Behroz Vaziri, Daniel Kahn, Debra Hoppensteadt, Nil Guler, Jawed Fareed
Recombinant factor VIIa (rFVIIa) is used in the management of bleeding in patients with hemophilia. A generic biosimilar version of NovoSeven is also developed (AryoSeven). To compare the activation profile of NovoSeven and AryoSeven, 2 commercially available protein complex concentrates (PCCs) were used. Profilnine activated by RecombiPlasTin 2G resulted in conversions of prothrombin to prethrombin and thrombin at 5 to 30 minutes. However, addition of rFVIIa at final concentration range of 0.25 to 0.5 µg/mL to the same mixture resulted in total conversion of prothrombin to thrombin with a doublet at 36 kDa...
August 23, 2016: Clinical and Applied Thrombosis/hemostasis
Jennifer O Kwon, Robert MacLaren
STUDY OBJECTIVE: To evaluate fresh-frozen plasma (FFP), four-factor prothrombin complex concentrates (PCCs), and recombinant factor VIIa (rFVIIa) for lowering international normalized ratio (INR) and facilitating procedures in critically ill patients with hepatic impairment. DESIGN: Retrospective cohort study. SETTING: Intensive care units at a large university-affiliated teaching hospital. PATIENTS: Forty-five adults with hepatic impairment who were admitted between September 1, 2011, and December 31, 2015, and had an admission INR of 1...
October 2016: Pharmacotherapy
Aya Imafuku, Naoki Sawa, Yoshifumi Ubara, Kenmei Takaichi
Acquired hemophilia A (AHA) is a rare bleeding disorder caused by autoantibodies to coagulation factor VIII (FVIII). AHA onset during the induction of dialysis is extremely rare, and the management of blood access is difficult. We present a case of AHA that developed during induction of dialysis and treatment with double filtration plasmapheresis (DFPP). An 86-year-old man with chronic kidney disease was admitted to our hospital with multiple subcutaneous hemorrhages. Because of his prolonged activated partial thromboplastin time (aPTT) and high titer of inhibitors to FVIII, he was diagnosed with AHA, and prednisolone treatment was started...
August 22, 2016: Clinical Nephrology
Alexander Y Mitrophanov, Fania Szlam, Roman M Sniecinski, Jerrold H Levy, Jaques Reifman
BACKGROUND: The use of prothrombin complex concentrates in trauma- and surgery-induced coagulopathy is complicated by the possibility of thromboembolic events. To explore the effects of these agents on thrombin generation (TG), we investigated combinations of coagulation factors equivalent to 3- and 4-factor prothrombin complex concentrates with and without added antithrombin (AT), as well as recombinant factor VIIa (rFVIIa), in a dilutional model. These data were then used to develop a computational model to test whether such a model could predict the TG profiles of these agents used to treat dilutional coagulopathy...
September 2016: Anesthesia and Analgesia
Raymond Devlin, Laura Bonanno, Jennifer Badeaux
BACKGROUND: Rapid replacement of blood loss is critical in patients suffering from traumatic hemorrhage. When the availability of blood products is limited, certain interventions have shown promise in conserving blood supplies. Recombinant factor (rF) VIIa has been administered, as an off-label use, to assist in controlling hemorrhage in trauma patients. Although rFVIIa has a tendency to remain localized to areas of vascular insult, there may be an increase in thromboembolism formation when patients suffer multiple sites of injury as seen in blunt force trauma...
March 2016: JBI Database of Systematic Reviews and Implementation Reports
W-S Q See, K-O Chang, D K-L Cheuk, Y-Y R Leung, G C-F Chan, S-C Chan, S-Y Ha
Congenital factor VII (FVII) deficiency is the commonest type of the rare bleeding disorders. Very few cases of congenital FVII deficiency developed inhibitor and liver transplant is considered as definitive treatment. In the literature, twelve patients with congenital FVII deficiency developed inhibitors. Two had spontaneous resolution of inhibitors and one did not respond to high dose recombinant factor VIIa (rFVIIa) and died. Regarding liver transplant in congenital FVII patients, seven patients underwent liver transplant with good prognosis...
September 2016: Haemophilia: the Official Journal of the World Federation of Hemophilia
Patrick Schoettker, Carlos E Marcucci, Gabriele Casso, Catherine Heim
Transfusion of blood products can be life saving when used appropriately. It carries however at the same time a potential for morbidity and mortality, depending on the patient, the product or the setting. Numerous strategies have been elaborated to minimize these risks, and in recent years, transfusion has no longer been regarded as essential for the management of a wide range of diseases. Uncomplicated surgeries in well-prepared patients can now be conducted without the use of transfusions. Questions about transfusion safety and shortage have led to extensive research on alternatives to blood transfusion, ranging from non-pharmacological to pharmacological solutions...
July 2016: La Presse Médicale
K Amano, I Seita, S Higasa, A Sawada, M Kuwahara, M Shima
INTRODUCTION: Patients with acquired haemophilia A (AHA) have autoantibodies against factor VIII (FVIII), and may develop spontaneous bleeding that requires treatment with FVIII inhibitor bypassing agents such as recombinant activated FVII (rFVIIa, NovoSeven(®) ). However, data regarding the use of rFVIIa are limited. AIM: To investigate the use, efficacy and safety of rFVIIa for the treatment of AHA by analysis of 10-year multicentre Japanese postmarketing surveillance data...
July 25, 2016: Haemophilia: the Official Journal of the World Federation of Hemophilia
Kate Burley, Claire S Whyte, Sarah K Westbury, Mary Walker, Kathleen E Stirrups, Ernest Turro, Nihr BioResource, Oliver G Chapman, Christopher Reilly-Stitt, Nicola J Mutch, Andrew D Mumford
Thrombomodulin-associated coagulopathy (TM-AC) is a newly recognised dominant bleeding disorder in which a p.Cys537Stop variant in the thrombomodulin (TM) gene THBD, results in high plasma TM levels and protein C-mediated suppression of thrombin generation. Thrombin in complex with TM also activates thrombin activatable fibrinolysis inhibitor (TAFI). However, the effect of the high plasma TM on fibrinolysis in TM-AC is unknown. Plasma from TM-AC cases and high-TM model control samples spiked with recombinant soluble TM showed reduced tissue factor-induced thrombin generation...
July 19, 2016: Blood
Steven R Lentz, Savita Rangarajan, Faraizah A Karim, Philip D Andersen, Per Arkhammar, Gabriela Rosu, Johnny Mahlangu
Haemophilia treatment guidelines advocate early home-based treatment of acute bleeds. In the ADEPT2 trial, data were collected on the home treatment of bleeds with recombinant activated factor VII (rFVIIa) in haemophilia patients with inhibitors and self-reported bleeding-related symptoms. A total of 93% of all bleeds, and 91.5% of joint bleeds, were treated successfully with one to three doses of 90 μg/kg rFVIIa. However, some patients self-administered additional haemostatic medication (AHM) up to 48 h after the first rFVIIa treatment...
July 13, 2016: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
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