Comparison of a chromogenic factor X assay with international normalized ratio for monitoring oral anticoagulation therapy

2008 ◽  
Vol 19 (6) ◽  
pp. 513-517 ◽  
Author(s):  
David L McGlasson ◽  
Benjamin G Romick ◽  
Bernard J Rubal
Keyword(s):  
Oral Anticoagulation ◽  
Anticoagulation Therapy ◽  
International Normalized Ratio ◽  
Factor X ◽  
Oral Anticoagulation Therapy

A Multi-Instrument Evaluation of a Commercial Chromogenic Factor X Assay To Monitor Oral Anticoagulation Therapy.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4059-4059 ◽  
Author(s):  
David L. McGlasson ◽  
Patrick N. Shaklee
Keyword(s):  
Oral Anticoagulation ◽  
Anticoagulation Therapy ◽  
Normal Subjects ◽  
Factor X ◽  
Normal Range ◽  
Precision Data ◽  
Oral Anticoagulation Therapy ◽  
Instrument Evaluation ◽  
Correlation Range ◽  
Precision Testing

Abstract Introduction: A multi-instrument evaluation of the chromogenic DiaPharma Factor X Assay kit (DFX) was undertaken in order to evaluate the utility of the kit for measuring factor X levels in patients receiving oral anticoagulation therapy (OAT). Methods: The DFX microtiter method was compared to a clottable FX (CFX)method in Laboratory 1. All clottable assays were performed on the Diagnostica-Stago STA automated coagulation analyzer using STA Neoplastine CI+ as the thromboplastin reagent with a low ISI. All testing was performed on citrated plasmas. A normal range was established using 30 normal subjects. Clinical sensitivity was tested using 30 specimens from subjects on OAT. The samples were assayed for FX levels by DFX and CFX, and international normalized ratios (INR) were calculated. Thirty-one specimens that were positive for the presence of hemolysis, icteric color, lipemia, heparin and lupus anticoagulants (LA) were analyzed for FX by both methods to check for the influence of interfering substances. Nineteen subjects with the presence of an LA on OAT and an unstable INR with specimens taken at 8 time points were evaluated by both methods. Laboratory 2 used an STA compact and reagents to evaluate both the CFX and DFX methods. A normal range was established using 25 normal subjects on both methods. Fifty-five subjects on OAT were evaluated by both the CFX and the DFX methods. Precision and accuracy testing using different levels of FX were analyzed by all methods at both institutions. Results: The results of both laboratories are as follows: FX Chromogenic vs. Clotting Precision Data: Laboratory 1 performed precision testing using times 10 replicates on 6 specimens, run on the DFX in the range of 10 – 120% FX activity. Using 5 known standards for the DFX, assay accuracy ranged from 99.2 – 100.8% recovery. Laboratory 2 performed precision testing on 3 levels of FX (n = 12). Precision Data Conclusions: The present studies of the DFX kit demonstrated the assays robustness, precision, accuracy and utility for monitoring patients on OAT with and without interfering substances, the presence of an LA or unstable INR. The DiaPharma Factor X Kit recently received 510(k) market clearance from the FDA. This assay should offer health care providers an option for monitoring patients receiving OAT, especially those where INR values may not be reliable when an LA is present, and screening for factor X deficiencies. Laboratory 1 Normals (n=30) OAT (n=30, INR=1.74-5.9) Range Mean Correlation Range Mean Correlation Chromogenic 72.0 – 137.6% 113.8% 0.906 19.3 – 62.5% 31.0% 0.903 Clotting 94.1 – 159.7% 109.5% 7.0 – 48.0% 13.9% OAT with presence of LA (n = 19) Interfering Substances (n=31, INR 1.0 – 1.2) Range Mean Correlation Range Mean Correlation Chromogenic 7.0 – 122.0% 33.1% 0.841 101.2 – 126.4% 113.8% 0.906 Clotting 2.7 – 101.0% 22.8% 97.4 – 120.7% 109.5% Laboratory 2 Normals (n = 25) OAT (n=55) Range Mean Correlation Range Mean Correlation Chromogenic 83.0 – 147.0% 120.4% 0.871 17.0 – 65.0% 32.5% 0.948 Clotting 69.0 – 139.0% 105.7% 2.0 – 41.0% CV (%) Laboratory 1 Laboratory 2 Chromogenic 1.9 – 10.4% 2.5 – 5.1% Clotting N/A 4.6 – 9.2%

Implementation of SintromacWeb®, a new internet-based tool for oral anticoagulation therapy telecontrol: Study on system consistency and patient satisfaction

2010 ◽  
Vol 103 (05) ◽  
pp. 1091-1101 ◽  
Author(s):  
Yolanda Mira ◽  
María Teresa Contreras ◽  
Cristina Aguado ◽  
José Antonio Aznar ◽  
Fernando Ferrando
Keyword(s):  
Patient Satisfaction ◽  
Oral Anticoagulation ◽  
Point Of Care ◽  
Anticoagulation Therapy ◽  
International Normalized Ratio ◽  
Final Visit ◽  
Normal Range ◽  
Oral Anticoagulation Therapy ◽  
Self Testing ◽  
Anticoagulated Patients

SummaryMost computer- or internet-assisted systems for oral anticoagulation therapy (OAT) telemanagement have limitations when it comes to implementation within a healthcare center. It was the objective of this study to evaluate convenience and patient satisfaction with the use of SintromacWeb→, a new OAT telecontrol system, compared with the conventional control. SintromacWeb® consists of a point-of-care device for patient international normalized ratio (INR) self-testing and software that allows internet mediated interaction with physicians. Patients initiated the use of SintromacWeb→ and were followed up during a three-month period. A score-based questionnaire was completed in three controlled visits, and data were subsequently analysed. A total of 102 patients were enrolled. At first visit, 55.7% of the patients had their INR within normal range, and 64.9% at the final visit. Internal consistency of the questionnaire was good (Cronbach‘s α: 0.79). Scores in the questionnaire were independent of patient’s age, education level, working status and INR value. The most valued features of SintromacWeb® were: fewer visits to the hospital, simplicity and convenience of the system, and time administration for control tasks (86.7%, 82.7% and 77.6% of very satisfied patients, respectively). Also, patients showed indifference or were dissatisfied with the conventional system. At the final visit, 99% of patients declared that they were satisfied with their OAT control. Moreover, all patients continued using Sintrom -acWeb→ after completion of the study. In conclusion, SintromacWeb→ telecontrol is a new model for management of anticoagulated patients. It was highly accepted and can be used by all patients regardless of their sociodemographic characteristics.

scholarly journals IMPACT OF PHARMACIST LED ANTICOAGULATION MONITORING AND PATIENT EDUCATION ON ORAL ANTICOAGULATION THERAPY WITH ACENOCOUMAROL

2017 ◽  
Vol 10 (10) ◽  
pp. 314
Author(s):  
Poojitha Reddy Reddy ◽  
Omsri Mounika ◽  
Gaddam Chandrika ◽  
Aldrich Franklin ◽  
Ramesh M ◽  
...  
Keyword(s):  
Patient Education ◽  
Drug Interactions ◽  
Oral Anticoagulation ◽  
Anticoagulation Therapy ◽  
Therapeutic Index ◽  
International Normalized Ratio ◽  
Rank Test ◽  
Oral Anticoagulation Therapy ◽  
Before And After ◽  
The Impact

  Objective: Acenocoumarol is anoral anticoagulant with narrow therapeutic index, and the ideal dose of anticoagulation lies between International normalized ratio (INR) values of 2.0 and 3.5. Lack of monitoring and knowledge on acenocoumarol therapy may compromise patient’s safety resulting in under- or over-anticoagulation. A study was conducted to monitor for the safety of anticoagulation therapy, achievement of goal INR levels and to assess the impact of pharmacist led anticoagulation monitoring and patient education on the rational use of acenocoumarol in patients admitted in cardiology wards with thromboembolic disorders.Methods: The study was conducted in 70 patients; data collection was done, prescriptions were analyzed for drug-drug interactions and adverse drug reactions (ADRs). Patients’ knowledge on acenocoumarol therapy was assessed using a self-developed questionnaire at the baseline, then were subjected to a detailed patient education and on an average each patient received three sessions of education. They were again made to answer the same questionnaire on the day of discharge. The mean score of the responses before and after education was compared statistically using Wilcoxon signed rank test and McNemar test.Results: There were 60% patients under anticoagulated with the INR range of >2.0. 123 drug interactions were observed in 58 patients, on an average of 2 interactions per prescription, but no ADRs were observed. 59 patients (84.3%) showed significant overall improvement in knowledge on anticoagulation therapy following education.Conclusion: This study implies the role of clinical pharmacists in achieving better clinical outcomes in patients receiving oral anticoagulation therapy with acenocoumarol.

scholarly journals Poor Agreement among Prothrombin Time International Normalized Ratio Methods: Comparison of Seven Commercial Reagents

2005 ◽  
Vol 51 (3) ◽  
pp. 553-560 ◽  
Author(s):  
Juha Horsti ◽  
Helena Uppa ◽  
Juhani A Vilpo
Keyword(s):  
Clinical Practice ◽  
Patient Care ◽  
Prothrombin Time ◽  
Oral Anticoagulation ◽  
Anticoagulation Therapy ◽  
International Normalized Ratio ◽  
Poor Agreement ◽  
Oral Anticoagulation Therapy ◽  
The Mean ◽  
The Difference

Abstract Background: Prothrombin time (PT) has long been the most popular test for monitoring oral anticoagulation therapy. The International Normalized Ratio (INR) was introduced to overcome the problem of marked variation in PT results among laboratories and the various recommendations for patient care. According to this principle, all reagents should be calibrated to give identical results and the same patient care globally. This is necessary for monitoring of single patients and for application of the results of anticoagulation trials and guidelines to clinical practice. Methods: We took blood samples from 150 patients for whom oral anticoagulation had been prescribed. Plasmas were separated and PTs determined by use of seven commercial reagents and four calibrator sets. The differences in results were assessed by plotting, for each possible pair of methods, the differences in INR values for each sample against the mean INR value (Bland-Altman difference plots). Results: Mean results differed significantly (P <0.001) for 17 of 21 possible paired comparisons of methods. Only two pairs of methods produced very similar results when assessed for problems of substantial differences in INR values; a significant, systematic increase in the difference with INR; and a significant systematic increase in the variation in difference with increasing INR values. Conclusions: The agreement among several (and perhaps most) commercial INR methods is poor. The failure of current calibration strategies may severely compromise both the monitoring of individual patients and the application of oral anticoagulation guidelines and trial results to clinical practice.

Ervaringen tijdens de "Belgian Improvement Study on Oral Anticoagulation Therapy" (BISOAT)

2005 ◽  
Vol 61 (11) ◽  
pp. 841-847 ◽  
Author(s):  
CLAES N ◽  
BUNTINX F ◽  
VIJGEN J ◽  
ARNOUT J ◽  
VERMYLEN J ◽  
...  
Keyword(s):  
Oral Anticoagulation ◽  
Anticoagulation Therapy ◽  
Oral Anticoagulation Therapy

Depression and Uptake of Oral Anticoagulation Therapy in Patients With Atrial Fibrillation

Medical Care ◽  
2020 ◽  
Vol 58 (3) ◽  
pp. 216-224 ◽  
Author(s):  
Morten Fenger-Grøn ◽  
Claus H. Vestergaard ◽  
Lars Frost ◽  
Dimitry S. Davydow ◽  
Erik T. Parner ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulation ◽  
Anticoagulation Therapy ◽  
Oral Anticoagulation Therapy

Consideration of non-valvular atrial fibrillation with left atrial appendage thrombus formation despite under appropriate oral anticoagulation therapy

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Shiraki ◽  
H Tanaka ◽  
K Yamashita ◽  
Y Tanaka ◽  
K Sumimoto ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Oral Anticoagulation ◽  
Left Atrial ◽  
Thrombus Formation ◽  
Anticoagulation Therapy ◽  
Left Ventricular ◽  
Volume Index ◽  
Oral Anticoagulation Therapy

Abstract Background Atrial fibrillation (AF) is the most frequently sustained cardiac arrhythmia, with a prevalence of about 2–3% in the general population. In accordance with CHADS2 or CHA2DS2-VASc score, appropriate oral anticoagulation therapy such as warfarin or direct oral anticoagulants (DOAC) significantly reduced the risk of thromboembolic events. However, left atrial (LA) thrombus can be detected in the LA appendage (LAA) in AF patients despite appropriate oral anticoagulation therapy. Purpose Our purpose was to investigate the associated factors of LAA thrombus formation in non-valvular atrial fibrillation (NVAF) patients despite under appropriate oral anticoagulation therapy. Methods We retrospectively studied consecutive 286 NVAF patients for scheduled catheter ablation or electrical cardioversion for AF in our institution between February 2017 and September 2019. Mean age was 67.1±9.4 years, 79 patients (29.5%) were female, and 140 (52.2%) were paroxysmal AF. All patients underwent transthoracic and transesophageal echocardiography before catheter ablation or electrical cardioversion. All patients received appropriate oral anticoagulation therapy including warfarin or DOAC for at least 3 weeks prior to transesophageal echocardiography based on the current guidelines. LAA thrombus was defined as an echodense intracavitary mass distinct from the underlying endocardium and not caused by pectinate muscles by at least three senior echocardiologists. Results Of 286 NVAF patients with under appropriate oral anticoagulation therapy, LAA thrombus was observed in 9 patients (3.3%). Univariate logistic regression analysis showed that age, paroxysmal AF, CHADS2 score ≥3, left ventricular end-diastolic volume index (LVEDVI), left ventricular ejection fraction (LVEF), left ventricular mass index (LVMI), LA volume index (LAVI), mitral inflow E and mitral e' annular velocities ratio (E/e'), and LAA flow were associated with LAA thrombus formation. It was noteworthy that multivariate logistic regression analysis showed that LAA flow was independent predictor of LAA thrombus (OR: 0.72, 95% CI: 0.59–0.89, p<0.005) as well as LVEF. Furthermore, receiver operating characteristic (ROC) curve analysis identified the optimal cutoff value of LAA flow for predicting LAA thrombus as ≤15cm/s, with a sensitivity of 88%, specificity of 93%, and area under the curve (AUC) of 0.95. Conclusions LAA flow was strongly associated with LAA thrombus formation even in NVAF patients with appropriate oral anticoagulation therapy. According to our findings, further strengthen of oral anticoagulation therapy or percutaneous transcatheter closure of the LAA may be considered in NVAF patients with appropriate oral anticoagulation therapy but low LAA flow, especially <15cm/s. Funding Acknowledgement Type of funding source: None

Management of Oral Anticoagulation Therapy After Gastrointestinal Bleeding: Whether to, When to, and How to Restart an Anticoagulation Therapy

2017 ◽  
Vol 51 (11) ◽  
pp. 1000-1007 ◽  
Author(s):  
Kazuhiko Kido ◽  
Michael J. Scalese
Keyword(s):  
Gastrointestinal Bleeding ◽  
Cohort Studies ◽  
Oral Anticoagulation ◽  
Retrospective Cohort ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Cochrane Library ◽  
Oral Anticoagulation Therapy ◽  
Retrospective Cohort Studies

Objective: To evaluate current clinical evidence for management of oral anticoagulation therapy after gastrointestinal bleeding (GIB) with an emphasis on whether to, when to, and how to resume an anticoagulation therapy. Data Sources: Relevant articles from MEDLINE, Cochrane Library, and EMBASE databases were identified from 1946 through May 20, 2017, using the keywords: gastrointestinal hemorrhage or gastrointestinal bleeding and antithrombotic therapy or anticoagulation therapy or warfarin or dabigatran or rivaroxaban or apixaban or edoxaban.Study Selection and Data Extraction: All English-language studies assessing management of oral anticoagulation therapy after GIB were evaluated. Data Synthesis: A total of 9 studies were identified. Four retrospective cohort studies showed that resuming anticoagulation therapy was associated with significantly lower rate of thromboembolism (TE) in the general population. Meta-analyses and prospective cohort studies also supported this finding. Two retrospective cohort studies indicated an increase in GIB when anticoagulation reinitiation occurred in less than 7 days without a decrease in TE. Resuming therapy between 7 and 15 days did not demonstrate a significant increase in GIB or TE. A large retrospective study showed that apixaban was associated with the significantly lowest risk of GIB compared with both rivaroxaban and dabigatran. Conclusion: Anticoagulation therapy resumption is recommended, with resumption being considered between 7 and 14 days following GIB regardless of the therapy chosen. Data for warfarin management after GIB should be applied with caution to direct oral anticoagulants (DOACs) because of the quicker onset and experimental nature of reversal agents. Apixaban may be a preferred option when restarting a DOAC therapy.

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