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J S Biedermann, A M van den Besselaar, F W Leebeek, M J Kruip
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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
A M H P van den Besselaar, Joseph S Biedermann, Marieke J H A Kruip
Many patients treated with vitamin K antagonists (VKA) determine their INR using point-of-care (POC) whole blood coagulation monitors. The primary aim of the present study was to assess the INR within-subject variation in self-testing patients receiving a constant dose of VKA. The second aim of the study was to derive INR imprecision goals for whole blood coagulation monitors. Analytical performance goals for INR measurement can be derived from the average biological within-subject variation. Fifty-six Thrombosis Centres in the Netherlands were invited to select self-testing patients who were receiving a constant dose of either acenocoumarol or phenprocoumon for at least six consecutive INR measurements...
November 25, 2015: Thrombosis and Haemostasis
Macit Kalçık, Mahmut Yesin, Mustafa Ozan Gürsoy, Sabahattin Gündüz, Süleyman Karakoyun, Mehmet Ali Astarcıoğlu, Emrah Bayam, Sinan Cerşit, Mehmet Özkan
BACKGROUND: Warfarin, which is a widely used oral anticoagulant, has a narrow therapeutic window and requires regular international normalized ratio (INR) monitoring to maintain optimal anticoagulation. Recently, several portable coagulometers have been developed to measure INR levels. OBJECTIVE: To compare the INR results obtained by a portable coagulometer (CoaguChek XS) and a standard laboratory method (STAGO STA-R). METHODS: Overall, 433 consecutive patients (male: 191, median age: 61 [44-86] years) who were admitted to outpatient anticoagulation clinic were enrolled in this study...
July 15, 2015: Clinical and Applied Thrombosis/hemostasis
Joseph S Biedermann, Frank W G Leebeek, Peter N Buhre, Sacha de Lathouder, Jan P F Barends, Moniek P M de Maat, Felix J M van der Meer, Marieke J H A Kruip
INTRODUCTION: Introducing point-of-care (POC) INR measurement to monitor anticoagulant therapy may be beneficial for both patients and anticoagulation clinics. However, agreement between POC and laboratory INR results is still unclear, especially at sub- and supratherapeutic levels. Therefore we investigated the analytical and clinical agreement between POC INR results of the Coaguchek XS and laboratory INR results of the STA-R Evolution. MATERIALS AND METHODS: Paired POC and laboratory INR results were obtained and analyzed in 3257 patients aged 18-104 years between August 2008 and March 2014...
September 2015: Thrombosis Research
Pawana Sharma, Graham Scotland, Moira Cruickshank, Emma Tassie, Cynthia Fraser, Chris Burton, Bernard Croal, Craig R Ramsay, Miriam Brazzelli
BACKGROUND: Self-monitoring (self-testing and self-management) could be a valid option for oral anticoagulation therapy monitoring in the NHS, but current evidence on its clinical effectiveness or cost-effectiveness is limited. OBJECTIVES: We investigated the clinical effectiveness and cost-effectiveness of point-of-care coagulometers for the self-monitoring of coagulation status in people receiving long-term vitamin K antagonist therapy, compared with standard clinic monitoring...
June 2015: Health Technology Assessment: HTA
Keiko Yamamura, Koji Yano, Yoshiki Hirooka, Akihiro Hirashiki, Toyoaki Murohara, Kiyofumi Yamada
  To avoid major bleeding events in warfarin and S-1 combination therapy, PT-INR levels should be monitored frequently to allow for precise adjustments of the warfarin dose and to verify any side effects reported by the patient. We therefore developed a support system where outpatients obtain a home-measured PT-INR value using the CoaguChek(®) system and submit it along with details of any side effects to us via the Internet using their mobile phone. A 59-year-old man was started on warfarin (1.5 mg/d) and S-1 (100 mg/d), a combination preparation of tegafur, gimeracil, and oteracil potassium, to treat cholangiocarcinoma...
2015: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
Mecki Isert, Wolfgang Miesbach, Gundolf Schüttfort, Yvonne Weil, Vanessa Tirneci, Alexander Kasper, Adele Weber, Edelgard Lindhoff-Last, Eva Herrmann, Birgit Linnemann
Because of the possible interference of antiphospholipid antibodies (APL) with the phospholipid component of thromboplastin reagents, concerns have been raised about the validity of international normalized ratio (INR) testing to monitor anticoagulant therapy with vitamin K antagonists in patients with antiphospholipid syndrome (APS). To investigate the reliability of the INR, we determined the INR using various prothrombin time (PT) assays and compared the results with those of a chromogenic factor X (CFX) assay...
August 2015: Annals of Hematology
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