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PubMed1995

International Normalized Ratio (INR): an improved way to monitor oral anticoagulant therapy.

Oral anticoagulant therapy may be inappropriately managed and thus potentially place the warfarin-treated patient at an increased and unnecessary risk of bleeding or thromboembolic complications. This management issue is largely due to variations in measuring the pro-thrombin time. These variations may lead to an inaccurate and inconsistent assessment of the patient's true level of anticoagulation. The adoption of the International Normalized Ratio (INR) is recommended because it provides a mathematical correction for one of these variations--specifically, the thromboplastin reagents currently used. This article focuses on the appropriate use of the INR to monitor patients' responses to warfarin sodium therapy. It is vitally important for health care providers to be aware of the INR, to use it in clinical practice, and to interpret it correctly.

Administration, Oral↗
PubMed1995

International normalized ratio for prothrombin times in patients taking oral anticoagulants: critical difference and probability of significant change in consecutive measurements.

To determine when a change in serial measurements of prothrombin time in patients receiving oral anticoagulant therapy (ACT) is a statistically significant biological change necessitating dose adjustment, one must know the size of the "critical difference" in statistical terms (i.e., probabilities). In a cohort of 32 ACT patients at pharmacological steady-state, we studied the within-subject total variation of prothrombin time, expressed as International Normalized Ratio (INR), over 6 months. The total within-subject variation (CV) of INR was 10.1%. The corresponding critical differences required for significance of change in serial INR results was 0.7 at a therapeutic target of 2.5 INR and 1.0 at a therapeutic target of 3.5 INR. The data presented allow generation of objective criteria for monitoring ACT patients and deciding dose adjustments. We recommend that estimations of critical differences for significant change of INR in ACT patients should be based on results obtained in the specific clinic investigated to mirror the routine total variation of INR measurements they obtain.

Aged↗
PubMed1995

A partial factor V deficiency in anticoagulated lyophilized plasmas has been identified as a cause of the international normalized ratio discrepancy in the external quality assessment scheme.

Lyophilized normal and anticoagulated plasmas are increasingly used in External Quality Assessment schemes (EQAS) to assess the quality of performance of laboratories engaged in the control of oral anticoagulant therapy by means of the International Normalized Ratio (INR) system and for the standardization of the prothrombin time (PT). The main feature of the INR system is that the value measured for an individual plasma should be independent of the reagent used. This holds true only if the variable factors influencing the responsiveness of the reagents are the vitamin K-dependent clotting factors, the other factors being constant and within normal limits. We provide evidence that even a partial factor V (FV) deficiency (FV activity < 60 U/dl) in anticoagulated plasmas can be responsible for discrepancies between INR values as measured for a single lyophilized or fresh plasma by different reagents and that the discrepancy is proportional to and magnified by the International Sensitivity Index (ISI) of the reagent used. The greater the difference between ISI values, the wider the gap between INR values. Since FV is one of the most labile plasma clotting factors, its activity is likely to be lost during freeze-drying. Hence, we recommend a thorough control of the FV activity in commercial and home-made lyophilized plasmas before their use in EQAS and in the standardization of the PT.

Blood Banks↗
PubMed1994

Monitoring warfarin therapy with the international normalized ratio.

OBJECTIVE: To report a case of suboptimal warfarin monitoring. CASE SUMMARY: A patient with a history of rheumatic heart disease and a mechanical mitral valve was admitted to the local hospital complaining of left-sided weakness. At the time, she was receiving warfarin 5 mg/d. Upon admission her prothrombin time (PT) was 15 s. An initial computed tomography (CT) scan of the head was negative. On the basis of the initial findings, it was unclear whether the symptoms were caused by a cerebrovascular accident (CVA). The patient was transferred to the University Medical Center for a more thorough evaluation. The diagnosis of CVA was confirmed by a repeat CT scan seven days after the event. On the basis of the information obtained from the local hospital, it was determined that the initial PT of 15 s converted to an International Normalized Ratio (INR) of 1.5, which is below the recommended range for patients with mechanical heart valves. Prior to discharge, the warfarin dosage was increased to obtain an INR in the recommended range of 2.5-3.5. DISCUSSION: This case illustrates the problems that exist with the current system of PT reporting and the potential advantages of using the INR. Variations in the sensitivity of the thromboplastin reagents used to perform the PT may result in misinterpretation of the level of anticoagulation and errors in warfarin dosage adjustments. The potential for suboptimal anticoagulation is greatly increased in patients, such as the one reported here, who are having PTs performed by multiple laboratories. CONCLUSIONS: To maximize efficacy and minimized the risk of bleeding complications, warfarin therapy must be individualized and closely monitored. Standardization of PT monitoring through the use of the INR would significantly reduce the potential for suboptimal anticoagulation associated with the traditional system of reporting.

Cerebrovascular Disorders↗
PubMed1997

Plasma levels of factors II, VII and X and their relationship to the international normalized ratio during chronic warfarin therapy.

Monitoring of oral anticoagulant therapy is usually undertaken with the prothrombin time (PT), which is influenced by factors II, X, and VII. A number of studies have suggested that the prothrombin (factor II) level may be the most important determinant of the therapeutic efficacy of these drugs. Although some studies suggest that oral anticoagulants induce a similar residual level of plasma vitamin K-dependent proteins, others have called this into question. We therefore measured plasma levels of factors II, X, and VII in 50 patients undergoing chronic Warfarin therapy. The plasma levels of factors II, X, and VII were significantly different. Although the factor X levels of all plasmas were < 30%, levels of factors II and VII were > 30% in 14% and 50% of the samples, respectively. Multivariable analysis showed factor II levels to be the least significant of the three factors measured in determining the international normalized ratio of plasma or whole blood. Thus, plasma levels of the vitamin K-dependent coagulation factors are not equal in patients on chronic Warfarin therapy. If factor II (prothrombin) levels are indeed the major determinants of the therapeutic efficacy of Warfarin, alternative means of monitoring that more accurately reflects prothrombin levels should be evaluated.

Administration, Oral↗
PubMed2002

European Concerted Action on Anticoagulation (ECAA): International Normalized Ratio variability of CoaguChek and TAS point-of-care testing whole blood prothrombin time monitors.

The object was to assess the variability in displayed International Normalised Ratio (INR) between monitors of the same manufacture using whole blood samples from the same subjects. Two brands of monitor, CoaguChek Mini and the TAS PT-NC were tested. 14 instruments of each brand were tested on the same day at the same laboratory by the same operator using identical blood samples to avoid between-centre differences in samples and operator technique. Whole blood samples from two normal donors and four coumarin-treated patients were tested to assess between-instrument variability of INR. Results have been coded. There was a much wider dispersion of INR on Brand B than on Brand A. One Brand A instrument failed to give a result with one of the two whole blood samples from one patient. One Brand B monitor gave an aberrant result with one of the samples from a normal subject. On both brands of monitor, INR variability appeared to be due mainly to duplication differences rather than between-instrument variability on both normal and coumarin whole blood samples.

Analysis of Variance↗