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Bleeding reversal

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https://www.readbyqxmd.com/read/29346838/first-in-human-study-to-assess-safety-pharmacokinetics-and-pharmacodynamics-of-bms-962212-a-direct-reversible-small-molecule-factor-xia-inhibitor-in-non-japanese-and-japanese-healthy-subjects
#1
Vidya Perera, Joseph M Luettgen, Zhaoqing Wang, Charles E Frost, Cynthia Yones, Cesare Russo, John Lee, Yue Zhao, Frank P LaCreta, Xuewen Ma, Robert M Knabb, Dietmar Seiffert, Mary DeSouza, Pierre Mugnier, Brenda Cirincione, Takayo Ueno, Robert J A Frost
AIMS: To assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-962212, a first-in-class Factor XIa inhibitor, in Japanese and non-Japanese healthy subjects. METHODS: This was a randomized, placebo-controlled, double-blind, sequential, ascending dose study of 2 hour (Part A) and 5 day (Part B) intravenous (IV) infusions of BMS-962212. Part A used 4 doses (1.5, 4, 10, and 25 mg h-1 ) assigned to BMS-962212 or placebo in a 3:1 ratio per dose. Part B used 4 doses (1, 3, 9, and 20 mg h-1 ) enrolling Japanese (n = 4 active, n = 1 placebo) and non-Japanese subjects (n = 4 active, n = 1 placebo) per dose...
January 18, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29345686/reversal-agents-for-non-vitamin-k-antagonist-oral-anticoagulants
#2
REVIEW
Jerrold H Levy, James Douketis, Jeffrey I Weitz
The non-vitamin K antagonist oral anticoagulants (NOACs) include dabigatran, which inhibits thrombin, and apixaban, betrixaban, edoxaban, and rivaroxaban, which inhibit coagulation factor Xa. Although clinical studies of NOACs were conducted without antidotes, patient outcomes with major bleeding when receiving NOACs were no worse than those in patients treated with a vitamin K antagonist. Nonetheless, in patients with life-threatening bleeding or requiring urgent surgery, the capacity for rapid NOAC reversal is likely to increase patient safety...
January 18, 2018: Nature Reviews. Cardiology
https://www.readbyqxmd.com/read/29345592/prolonging-ticagrelor-beyond-a-year-of-acute-coronary-syndrome-worth-or-harmful
#3
Daniel Aradi, Dome Dezsi, Gabor Veress, Bela Merkely
Platelet activation plays a central role in triggering and complicating acute coronary syndromes, especially in case of stent thrombosis and myocardial infarction. On top of aspirin, P2Y12-inhibitors are successfully used to treat and prevent these events for a duration of one year after an acute coronary episode or 6 months after drug-eluting stent implantation. However, patients with acute coronary syndromes remain at heightened risk for recurrent ischemic events after the recommended durations of P2Y12-inhibitors and therefore, prolonging treatment is often considered in clinical practice...
January 16, 2018: Current Vascular Pharmacology
https://www.readbyqxmd.com/read/29344007/four-factor-prothrombin-complex-concentrate-improves-thrombin-generation-and-prothrombin-time-in-patients-with-bleeding-complications-related-to-rivaroxaban-a-single-center-pilot-trial
#4
Bettina Schenk, Stephanie Goerke, Ronny Beer, Raimund Helbok, Dietmar Fries, Mirjam Bachler
Background: Direct oral anticoagulants (DOACs) pose a great challenge for physicians in life-threatening bleeding events. The aim of this study was to test the efficacy of reversing the DOAC rivaroxaban using four-factor PCC (prothrombin complex concentrate), a non-specific reversing agent. Methods: Patients with life-threatening bleeding events during rivaroxaban treatment were included and administered 25 U kg-1 of PCC. Blood samples were collected immediately prior to as well as after PCC treatment at predefined time intervals...
2018: Thrombosis Journal
https://www.readbyqxmd.com/read/29343478/treatment-of-gastrointestinal-bleeding-with-idarucizumab-in-a-patient-receiving-dabigatran
#5
Jennifer Mourafetis, Norman Doctor, Simon Leung
PURPOSE: A case report describing use of idarucizumab for dabigatran reversal without the use of hemostatic agents in a patient who developed acute upper gastrointestinal (GI) bleeding while receiving triple antithrombotic therapy is presented. SUMMARY: A 77-year-old man with a complex cardiac history presented to the emergency room with chief complaints of black tarry stools and low blood pressures for 4 days. His past medical history included recent percutaneous coronary intervention (PCI) and drug-eluting stent (DES) placement, atrial fibrillation, hypertension, hyperlipidemia, coronary artery disease, coronary artery bypass graft surgery, stage 3 chronic kidney disease, and cholecystectomy...
January 17, 2018: American Journal of Health-system Pharmacy: AJHP
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
#6
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/29336885/structural-basis-for-activity-and-specificity-of-an-anticoagulant-anti-fxia-monoclonal-antibody-and-a-reversal-agent
#7
Lauren K Ely, Marco Lolicato, Tovo David, Kate Lowe, Yun Cheol Kim, Dharmaraj Samuel, Paul Bessette, Jorge L Garcia, Thomas Mikita, Daniel L Minor, Shaun R Coughlin
Coagulation factor XIa is a candidate target for anticoagulants that better separate antithrombotic efficacy from bleeding risk. We report a co-crystal structure of the FXIa protease domain with DEF, a human monoclonal antibody that blocks FXIa function and prevents thrombosis in animal models without detectable increased bleeding. The light chain of DEF occludes the FXIa S1 subsite and active site, while the heavy chain provides electrostatic interactions with the surface of FXIa. The structure accounts for the specificity of DEF for FXIa over its zymogen and related proteases, its active-site-dependent binding, and its ability to inhibit substrate cleavage...
January 2, 2018: Structure
https://www.readbyqxmd.com/read/29330279/rare-cause-of-isolated-severe-coagulation-failure-in-cirrhosis-traditional-healing-with-fenugreek
#8
Cyriac A Philips, Philip Augustine
Patients with cirrhosis develop decompensation events during the natural history of the disease that encompass ascites, variceal bleeding, hepatic encephalopathy and jaundice. Coagulation failure, defined using the international normalised ratio, even though not a decompensation event, is important in patients with stratifying cirrhosis into those who require liver transplantation for long-term survival. Isolated coagulation failure in cirrhosis is rare and usually occurs with use of anticoagulants in the setting of vascular diseases...
January 12, 2018: BMJ Case Reports
https://www.readbyqxmd.com/read/29310450/feasibility-of-a-collaborative-prospective-interdisciplinary-review-and-pharmacy-based-dispensing-process-for-prothrombin-complex-concentrate
#9
Maria Stratton, Philip Grgurich, Kurt Heim, Sandra Mackey, Joseph D Burns
BACKGROUND: Therapeutic options for rapid reversal of vitamin K antagonist therapy include 4-factor prothrombin complex concentrate (PCC4) and fresh frozen plasma (FFP). These agents have unique requirements for preparation, potential adverse effects, and cost-effectiveness considerations. OBJECTIVE: To retrospectively assess whether our process for collaborative prospective review and pharmacy preparation facilitates timely and safe warfarin reversal with PCC4 as compared with FFP and to compare effectiveness and safety of the agents in practice...
January 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29296829/safety-pharmacokinetics-and-reversal-of-apixaban-anticoagulation-with-andexanet-alfa
#10
Deborah Siegal, Genmin Lu, Janet M Leeds, Mark Karbarz, Janice Castillo, Vandana Mathur, Athiwat Hutchaleelaha, Uma Sinha, Michael Kitt, Matt McClure, Stanley J Hollenbach, John T Curnutte, Pamela B Conley, Mark Crowther
Direct factor Xa (FXa) inhibitors lack a specific reversal agent for emergencies such as major bleeding or urgent surgery. Andexanet alfa, a modified, catalytically inactive, recombinant human FXa derivative, reverses anticoagulant effect by binding and sequestering FXa inhibitors. This original report of safety and dose-finding, phase 1 and 2 randomized, double-blind, placebo-controlled studies, investigated various doses of andexanet in healthy volunteers. Phase 1 evaluated the safety and pharmacokinetics of andexanet (n = 24) or placebo (n = 8)...
September 26, 2017: Blood Advances
https://www.readbyqxmd.com/read/29280403/ticagrelor-in-modern-cardiology-an-up-to-date-review-of-most-important-aspects-of-ticagrelor-pharmacotherapy
#11
Dorota Danielak, Marta Karaźniewicz-Łada, Franciszek Główka
Ticagrelor is a first drug of a new chemical class cyclopentyltriazolopyrimidines. It is an antiplatelet agent with a unique mechanism of action, allowing a direct and reversible competitive inhibition of P2Y12 receptor. According to newest guidelines, it is recommended for prevention of thrombotic events in patients with acute coronary syndromes. Moreover, it is preferred over clopidogrel, an older generation antiplatelet drug, and therefore gains more interest in modern cardiology and vascular medicine. Areas covered: This review is a comprehensive and thorough summary of the most important findings on ticagrelor...
December 27, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29278982/the-use-of-kcentra%C3%A2-in-the-reversal-of-coagulopathy-of-chronic-liver-disease
#12
Deepika Pereira, Eric Liotta, Ahmed A Mahmoud
We aim to describe our experience with the four-factor prothrombin complex concentrates (4F-PCC) Kcentra® at differing doses in patients with liver cirrhosis requiring emergent hemostasis in the setting of major or life-threatening bleeding. An automated query of patients who received Kcentra between January 2014 and March 2016 was performed. Patients who had clinically significant bleeding and received Kcentra for treatment of coagulopathy of chronic liver disease (CCLD) were included in the study. Baseline patient demographics, administration indication, pertinent laboratory values, and other reversal therapies were collected...
January 1, 2017: Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/29276174/routine-use-of-anticoagulation-after-transcatheter-aortic-valve-replacement-initial-safety-outcomes-from-a-single-center-experience
#13
Sergey Gurevich, Brett Oestreich, Rosemary F Kelly, Mackenzie Mbai, Stefan Bertog, Demetris Yannopoulos, Santiago Garcia
BACKGROUND: Subclinical leaflet thrombosis (SCLT) can be seen in up to 12% of patients after transcatheter aortic valve replacement (TAVR). Anticoagulation appears to prevent and reverse SCLT but concerns exist about bleeding risk. METHODS: Our program adopted a strategy of routine anticoagulation after TAVR, starting warfarin on post-procedure day 0 and continuing for 3months in 10/2015. We report the initial safety and efficacy outcomes of this approach. Bleeding events were assessed using Valve Academic Research Consortium (VARC) and Bleeding Academic Research Consortium (BARC) definitions...
December 6, 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/29262430/reversal-of-oral-anticoagulants-for-intracerebral-hemorrhage-patients-best-strategies
#14
Lanting Fuh, Jonathan H Sin, Joshua N Goldstein, Bryan D Hayes
In patients with acute intracerebral hemorrhage (ICH), one of the major concerns is ongoing bleeding or ICH expansion. Anticoagulated patients are at higher risk of ongoing expansion and worse outcome. It may be that rapid anticoagulation reversal can reduce the risk of expansion and improve clinical outcome. For those taking coumarins, the best available evidence suggests that intravenous vitamin K combined with four-factor prothrombin complex concentrate (4F-PCC) is the most rapid and effective regimen to restore hemostasis...
December 2017: Seminars in Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29259514/dabigatran-induced-spontaneous-hemopericardium-and-cardiac-tamponade
#15
Qurat-Ul-Ain Jelani, Ram Gordon, Adam Schussheim
Four novel oral anticoagulant agents are currently available for the prevention and treatment of thromboembolic events in patients with nonvalvular atrial fibrillation. We present an unusual case of spontaneous hemopericardium and tamponade in an 87-year-old man with atrial fibrillation who was taking one such agent, dabigatran, as thromboprophylaxis. Our case highlights both a rare bleeding complication of dabigatran use and the effectiveness of idarucizumab, its newly approved reversal agent. Especially in elderly patients, we recommend that clinicians evaluate risk factors, closely monitor patient status, and consider alternatives to the newer anticoagulants when the risk of bleeding is high...
October 2017: Texas Heart Institute Journal
https://www.readbyqxmd.com/read/29250278/the-nonvitamin-k-antagonist-oral-anticoagulants-and-atrial-fibrillation-challenges-and-considerations
#16
REVIEW
Anna Plitt, Sameer Bansilal
The nonvitamin K antagonist oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban, and edoxaban are used for the reduction of the risk of stroke or systemic embolism (SEE) in patients with nonvalvular atrial fibrillation (NVAF). The purpose of this review is to highlight the safety and efficacy results of the pivotal NOAC clinical trials for use in NVAF, discuss some of the unique management challenges in the use of NOACs in special populations, summarize data on emerging and novel indications, and address potential future directions...
February 2017: Journal of Atrial Fibrillation
https://www.readbyqxmd.com/read/29247809/diclofenac-for-reversal-of-right-ventricular-dysfunction-in-acute-normotensive-pulmonary-embolism-a-pilot-study
#17
David Jimenez, Rosa Nieto, Jesús Corres, Covadonga Fernández-Golfín, Deisy Barrios, Raquel Morillo, Carlos Andres Quezada, Menno Huisman, Roger D Yusen, Jeffrey Kline
BACKGROUND: The inflammatory response associated with acute pulmonary embolism (PE) contributes to the development of right ventricular (RV) dysfunction. Nonsteroidal anti-inflammatory drugs (NSAIDs) may facilitate the reversal of PE-associated RV dysfunction. METHODS: We randomly assigned normotensive patients who had acute PE associated with echocardiographic RV dysfunction and normal systemic blood pressure to receive intravenous (IV) diclofenac (two doses of 75mg in the first 24h after diagnosis) or IV placebo...
December 5, 2017: Thrombosis Research
https://www.readbyqxmd.com/read/29245268/posterior-reversible-encephalopathy-syndrome-after-postpartum-hemorrhage-and-uterine-artery-embolization-a-case-report
#18
Fangfang Shi, Liwei Shen, Yonghui Shi, Lei Shi, Xiaoli Yang, Zhi Jin, Wenpeng Liu, Danhong Wu
RATIONALE: Posterior reversible encephalopathy syndrome (PRES) is characterized by clinical and radiological features, including headache, disturbed consciousness, seizures, and cortical blindness associated with findings indicating posterior leukoencephalopathy on imaging studies. Ours is the first case of PRES developing after postpartum hemorrhage and uterine artery embolization. PATIENT CONCERNS: An 18-year-old patient had postpartum hemorrhage after a normal delivery...
December 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29236888/convexity-subarachnoid-hemorrhage-clinical-features-and-etiology-of-an-argentinian-cohort
#19
Aníbal Chertcoff, Lucrecia Bandeo, Fátima Pantiu, Luciana León Cejas, Sol Pacha, Claudia Uribe Roca, Manuel Fernández Pardal, Ricardo Reisin, Pablo Bonardo
Nontraumatic convexity subarachnoid hemorrhage is an increasingly recognized subtype of subarachnoid bleeding. OBJECTIVE: Our aim was to describe the etiology and clinical features of a cohort of patients with convexity subarachnoid hemorrhage. METHODS: We retrospectively analyzed all cases of convexity subarachnoid hemorrhage admitted to our hospital between January 2012 and April 2017. Demographic features, clinical characteristics, complementary investigations, etiology and mortality were assessed...
December 2017: Arquivos de Neuro-psiquiatria
https://www.readbyqxmd.com/read/29234200/nutrition-and-muscle-in-cirrhosis
#20
REVIEW
Anil C Anand
As the cirrhosis progresses, development of complication like ascites, hepatic encephalopathy, variceal bleeding, kidney dysfunction, and hepatocellular carcinoma signify increasing risk of short term mortality. Malnutrition and muscle wasting (sarcopenia) is yet other complications that negatively impact survival, quality of life, and response to stressors, such as infection and surgery in patients with cirrhosis. Conventionally, these are not routinely looked for, because nutritional assessment can be a difficult especially if there is associated fluid retention and/or obesity...
December 2017: Journal of Clinical and Experimental Hepatology
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