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Sara R Vazquez, Ryan P Fleming, Stacy A Johnson
: A number of factors contribute to interlaboratory variation of international normalized ratio (INR) results. This variability can lead to differences in clinical decision-making. This prospective cohort study evaluated the accuracy, precision, and clinical decision-making variability of two point-of-care (POC) devices (CoaguChek XS and the Coag-Sense) to a clinical laboratory method of INR measurement as the 'reference' and by using the laboratory's accuracy standard (±25% of the reference INR). Study subjects included adults taking warfarin undergoing a POC INR with each device and a laboratory INR on the same day and evaluated differences in clinical decision-making using a warfarin nomogram...
April 4, 2017: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
Pierre Fontana, Lorenzo Alberio, Anne Angelillo-Scherrer, Lars M Asmis, Wolfgang Korte, Adriana Mendez, Pirmin Schmid, Hans Stricker, Jan-Dirk Studt, Dimitrios A Tsakiris, Walter A Wuillemin, Michael Nagler
BACKGROUND: Point-of-care testing (POCT) is regularly used to assess haemostasis in various clinical settings. The impact of rivaroxaban on those POCT is still elusive. We aimed to study the effects of rivaroxaban on most commonly used POCT assays. METHODS: Blood samples were taken before, 3h, and 24h after administration of 20mg rivaroxaban to 20 healthy volunteers as part of a prospective, multicenter validation study (clinicaltrials.govNCT01710267). Blood samples were analysed with thromboelastometry (ROTEM®), two platelet function assays (INNOVANCE® PFA-200 and Multiplate®), and the CoaguChek® XS...
March 21, 2017: Thrombosis Research
C Milleret, C Epiard, S Douchin, G Pernod, T Debillon
Neonatal severe protein C deficiency is a serious disease. There is no uniform approach for long-term preventive treatment of thrombotic events. We report the case of neonatal severe protein C deficiency treated with warfarin oral suspension. An international normalized ratio (INR) from 2.5 to 3.5 was expected. The INR was measured by home monitoring using the Coaguchek XS(®) (Roche Diagnostics, Mannheim, Germany) monitor. During 2years of warfarin treatment, there were only two minor episodes of purpuric access and no bleeding was reported...
April 2017: Archives de Pédiatrie: Organe Officiel de la Sociéte Française de Pédiatrie
Hiromi Kako, Vidya T Raman, Dmitry Tumin, Julie Rice, Joseph D Tobias
PURPOSE: Intraoperative abnormalities of coagulation function may occur for various reasons. In most scenarios, treatment is directed by laboratory parameters. Unfortunately, standard laboratory testing may take 1-2 h. The purpose of the current study was to evaluate a point-of-care testing device (CoaguChek(®) XS System) in pediatric patients. METHODS: Patients ranging in age from 2 to 18 years, undergoing posterior spinal fusion (PSF) or cardiac surgery using cardiopulmonary bypass (CPB) were eligible for inclusion...
February 17, 2017: Journal of Anesthesia
Yu Liu, Yi Zheng, Hulya Karatas, Xiaoying Wang, Christian Foerch, Eng H Lo, Klaus van Leyen
BACKGROUND AND PURPOSE: For stroke prevention, patients with atrial fibrillation typically receive oral anticoagulation. The commonly used anticoagulant warfarin increases the risk of hemorrhagic transformation (HT) when a stroke occurs; tissue-type plasminogen activator treatment is therefore restricted in these patients. This study was designed to test the hypothesis that 12/15-lipoxygenase (12/15-LOX) inhibition would reduce HT in warfarin-treated mice subjected to experimental stroke...
February 2017: Stroke; a Journal of Cerebral Circulation
J S Biedermann, A M H P van den Besselaar, M P M de Maat, F W G Leebeek, M J H A Kruip
Essentials Differences in sensitivity to factor VII (FVII) have been suggested between thromboplastins. FVII-induced International Normalized Ratio (INR) changes differ between commercial reagents. Recombinant human thromboplastins are more sensitive to FVII than tissue-extract thromboplastins. Thromboplastin choice may affect FVII-mediated INR stability. SUMMARY: Background Differences regarding sensitivity to factor VII have been suggested for recombinant human and tissue-extract thromboplastins used for International Normalized Ratio (INR) measurement, but the evidence is scarce...
January 5, 2017: Journal of Thrombosis and Haemostasis: JTH
J S Biedermann, A M van den Besselaar, F W Leebeek, M J Kruip
No abstract text is available yet for this article.
August 27, 2016: Journal of Thrombosis and Haemostasis: JTH
Shigeo Iijima, Toru Baba, Daizo Ueno, Akira Ohishi
INTRODUCTION: Early infants are at risk of vitamin K (VK) deficiency-associated bleeding unless they receive VK prophylaxis. A coagulation screening test might be necessary to detect prophylactic failure, but it is rarely conducted owing to the difficulty of blood sampling. CoaguChek XS is a portable, point-of-care (POC) coagulation analyzer that determines international normalized ratios (INRs) using only small volumes of blood. Although POC tests assessing INR have become widespread for adults, studies have not been performed in early infancy...
September 2016: Thrombosis Research
Shigeo Iijima, Katsuyuki Sekii, Toru Baba, Daizo Ueno, Akira Ohishi
BACKGROUND: The morbidity and mortality rates due to cardiovascular events such as myocardial infarction are known to exhibit seasonal variations. Moreover, changes in the ambient temperature are reportedly associated with an increase in these events, which may potentially involve blood coagulation markers. Bleeding due to vitamin K deficiency in neonates, which is associated with high mortality and a high frequency of neurological sequelae, is more commonly observed during the summer season and in warm regions in Japan...
2016: BMC Pediatrics
J Niederdöckl, C-E Dempfle, H-R Schönherr, A Bartsch, G Miles, A Laggner, A Pathil
INTRODUCTION: There are several clinical settings and patient conditions especially in intensive care units, emergency departments, and operating theaters, where the coagulation status of a patient must be known immediately and point-of-care (POC) systems are beneficial due to low time to result. METHODS: This noninterventional, single-blinded, multicenter study with prospectively collected whole blood samples was performed to evaluate the diagnostic accuracy of the CoaguChek PT Test (POC PT) and CoaguChek aPTT Test (POC aPTT) compared to standard laboratory testing in patients with suspected deficiencies of coagulation factors...
August 2016: International Journal of Laboratory Hematology
Konosuke Sasaki, Kiyoharu Sato, Marina Suzuki, Kiichiro Kumagai, Osamu Adachi, Yoshikatsu Saiki
Point of care devices have been widely applied to outpatients receiving anticoagulation therapy with warfarin for monitoring prothrombin time-international normalized ratio (PT-INR) regularly. However, accuracy in measurement with the device remains undetermined when PT-INR exceeds therapeutic range. We evaluated the performance of a portable CoaguChek XS coagulation analyzer in comparison with a conventional laboratory method according to therapeutic and supra-therapeutic PT-INR values in cardiac outpatients on oral vitamin K antagonists...
May 2016: Kyobu Geka. the Japanese Journal of Thoracic Surgery
Christopher Richter, James Taylor, Joyanna Wright, Bradley Fletcher
BACKGROUND: Despite the emergence of several new oral anticoagulants, warfarin remains a widely used form of anticoagulation that continues to have a role in the treatment of cardiac and thrombotic conditions. OBJECTIVE: The goal of this study was to evaluate whether the R-T estimation, an equation developed in a previous study, was a valid clinical tool in managing patients' warfarin therapy in an anticoagulation clinic in lieu of obtaining a venipuncture international normalized ratio (INR) secondary to a high CoaguChek XS (CXS) INR...
August 2016: Annals of Pharmacotherapy
Christopher Richter, James Taylor, Jonathan Shuster
BACKGROUND: The measurement of international normalization ratio (INR) may be done by venous blood draw and use of a standard lab, or by fingerstick, using a point of care (POC) device such as the CoaguChek XS(®) (Roche Diagnostics), and the CoaguChek XS(®) has been validated to meet the International Organization for Standardization (ISO) performance requirements. OVERVIEW: The goal of this study was to determine a correction factor for Coaguchek XS INR levels to a predicted venipuncture (VP) INR level...
March 2016: Point of Care
Fadiea Al-Aieshy, Rickard E Malmström, Jovan Antovic, Anton Pohanka, Yuko Rönquist-Nii, Maria Berndtsson, Faris Al-Khalili, Mika Skeppholm
PURPOSE: The one-dose daily regime of rivaroxaban could cause a pronounced variability in concentration and effect of which a deeper knowledge is warranted. This study aimed to evaluate the typical exposure range and effect of the direct factor Xa (FXa)-inhibitor rivaroxaban in a cohort of well-characterized patients with atrial fibrillation (AF). METHODS: Seventy-one AF patients (72 ± 8 years, 55 % men) were treated with rivaroxaban 15 mg/20 mg (n = 10/61) OD...
June 2016: European Journal of Clinical Pharmacology
Anne Stavelin, Berit Oddny Riksheim, Nina Gade Christensen, Sverre Sandberg
BACKGROUND: Providers of external quality assurance (EQA)/proficiency testing schemes have traditionally focused on evaluation of measurement procedures and participant performance and little attention has been given to reagent lot variation. The aim of the present study was to show the importance of reagent lot registration and evaluation in EQA schemes. METHODS: Results from the Noklus (Norwegian Quality Improvement of Primary Care Laboratories) urine albumin/creatinine ratio (ACR) and prothrombin time international normalized ratio (INR) point-of-care EQA schemes from 2009-2015 were used as examples in this study...
May 2016: Clinical Chemistry
E L Benade, B F Jacobson, S Louw, E Schapkaitz
BACKGROUND: Measurement of the international normalised ratio (INR) is essential in the management of patients on long-term warfarin therapy. The CoaguChek XS portable coagulometer is a point-of-care test for INR measurement. It offers the advantage of improved patient accessibility, particularly in peripheral clinics. OBJECTIVES: To evaluate the clinical utility of the CoaguChek XS for monitoring of patients on standard warfarin therapy (INR 2 - 3) as well as those with mechanical heart valve replacements (INR 2...
March 2016: South African Medical Journal, Suid-Afrikaanse Tydskrif Vir Geneeskunde
Jean-Guillaume Dillinger, Thiziri Si Moussi, Natacha Berge, Claire Bal Dit Sollier, Patrick Henry, Ludovic Drouet
BACKGROUND: Vitamin K antagonists (VKA) are widely prescribed throughout the world. Patients on VKA therapy require international normalized ratio (INR) monitoring of venous blood to ensure the response remains within the therapeutic window. Point-of-care devices (POC-INR) can safely and easily monitor VKA efficacy but need to be evaluated in practice. The aim of this study was to assess the precision and accuracy of a new POC-INR (Qlab) compared to the laboratory plasma technique and the CoaguChek-XS system...
April 2016: Thrombosis Research
Sabrina da Silva Saraiva, Fernanda Andrade Orsi, Marcos Pereira Santos, Tania Machado, Silmara Montalvão, Carolina Costa-Lima, Erich Vinícius de Paula, Marina Pereira Colella, Joyce Annichino-Bizzacchi
The home prothrombin time/international normalized ratio (PT/INR) self-management could be convenient for patients, enhancing treatment compliance and improving the quality of the oral anticoagulation. However, patient self-management (PSM) of oral anticoagulation may not be feasible for up to half of the patients due to cognitive or educational issues. In the present study, we aimed to evaluate the feasibility of a PSM program in a public health medical center that provides care for low-income patients. We also aimed to determine the accuracy of individual point-of-care devices (CoaguChek XS(®)) during long-term of home manipulation...
July 2016: Journal of Thrombosis and Thrombolysis
Matthias Ebner, Andreas Peter, Charlotte Spencer, Florian Härtig, Ingvild Birschmann, Joachim Kuhn, Martin Wolf, Natalie Winter, Francesca Russo, Christine S Zuern, Gunnar Blumenstock, Ulf Ziemann, Sven Poli
BACKGROUND AND PURPOSE: Specific coagulation assays for non-vitamin K antagonist oral anticoagulants (NOAC) are relatively slow and often lack availability. Although specific point-of-care tests (POCT) are currently not available, NOAC are known to affect established coagulation POCT. This study aimed at determining the diagnostic accuracy of the CoaguChek POCT to rule out relevant concentrations of rivaroxaban, apixaban, and dabigatran in real-life patients. METHODS: We consecutively enrolled 60 ischemic stroke patients newly started on NOAC treatment and obtained blood samples at 6 prespecified time points...
October 2015: Stroke; a Journal of Cerebral Circulation
Christopher Beynon, Angelina G Erk, Anna Potzy, Stefan Mohr, Erik Popp
BACKGROUND: Haemostatic impairment can have a crucial impact on the outcome of emergency patients, especially in cases of concomitant antithrombotic drug treatment. In this prospective observational study we used a point of care (POC) coagulometer in a prehospital physician-based emergency medical system in order to test its validity and potential value in the treatment of emergency patients. METHODS: During a study period of 12 months, patients could be included if venous access was mandatory for further treatment...
2015: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
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