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PubMedDate not supplied

The International Normalized Ratio as a measure of anticoagulation: significance for the management of the dental outpatient.

Susceptibility to bleeding in the patient treated with coumarin derivatives poses difficult management issues for the dentist. Classic monitoring for anticoagulation relied on the prothrombin time, but reagent variability issues have caused the emergence of the International Normalized Ratio (INR) as an alternative, and possibly more reliable, laboratory test for the assessment of a patient's anticoagulation status. The literature suggests that an INR range of 1.5 to 2.5 represents the most appropriate level of anticoagulation for the surgical patient. That is, at this INR, some protection is afforded against thrombo-embolic events without significantly sacrificing effective post-operative hemostasis. Since the patient with an INR value within the recommended range is still anticoagulated, he/she is still at risk for post-operative bleeding. Adherence to local hemostatic measures--such as pressure, topical thrombin, alveolar-placed resorbable sponges, and primary wound closure--offers the patient important adjunctive protection against post-operative bleeding.

Ambulatory Care↗
PubMed2002

Variations of prothrombin time and international normalized ratio in patients treated with warfarin.

Prothrombin time is a standard screening test to monitor patients treated with oral anticoagulants. We hypothesize that INR measurements will not vary a lot within a given day in a given patient. The present study was thus conducted to compare the change of the international normalized ratio (INR) of prothrombin time (PT) within 1 day in patients treated with warfarin. Thirty such patients and nineteen healthy controls were enrolled into this study. PT was performed in four time points of a day in all subjects, two in the morning and two in the afternoon. The four INR values obtained were compared with each other to find little change in the series of time either in patients or in healthy controls. Neither were they affected by renal function, liver function, sex, age, hemoglobin, white cell count, platelet, treatment duration of warfarin, or alcoholic drinking. INR could be measured in any time of a day to have values equally valuable in clinical use.

Aged↗
PubMedDate not supplied

Dental management of a child on anticoagulant therapy and the International Normalized Ratio: case report.

A 7-year-old girl with a history of four prosthetic heart valve replacements and daily anticoagulant therapy was treated with modification of the anticoagulant regimen and hospitalization. Coagulation times now are being expressed using the International Normalized Ratio (INR), a move by the international medical community to standardized laboratory values worldwide. This report describes this new measure and its role in patient assessment.

Child↗
PubMed2000

Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis.

PURPOSE: Initial heparinization followed by vitamin K antagonists is the treatment of choice for patients with venous thromboembolism. There is controversy whether known malignancy is a risk factor for recurrences and bleeding complications during this treatment. Furthermore, the incidence of such events in these patients is dependent on the achieved International Normalized Ratio (INR). The aim of this study was to assess the incidence of venous thromboembolic recurrence and major bleeding among patients with venous thromboembolism in relation to both malignancy and the achieved INR. PATIENTS AND METHODS: In a retrospective analysis, the INR-specific incidence of venous thromboembolic and major bleeding events during oral anticoagulant therapy was calculated separately for patients with and without malignancy. Eligible patients participated in two multicenter, randomized clinical trials on the initial treatment of venous thromboembolism. Patients were initially treated with heparin (standard or low-molecular weight). Treatment with vitamin K antagonists was started within 1 day and continued for 3 months, with a target INR of 2.0 to 3.0. RESULTS: In 1,303 eligible patients (264 with malignancy), 35 recurrences and 12 bleeds occurred. Patients with malignancy, compared with nonmalignant patients, had a clinically and statistically significantly increased overall incidence of recurrence (27.1 v 9.0, respectively, per 100 patient-years) as well as bleeding (13.3 v 2.1, respectively, per 100 patient-years). In both groups of patients, the incidence of recurrence was lower when the INR was above 2.0 compared with below 2.0. CONCLUSION: Although adequately dosed vitamin K antagonists are effective in patients with malignant disease, the incidence of thrombotic and bleeding complications remains higher than in patients without malignancy.

Aged↗
PubMed2001

Disagreement between bedside and laboratory activated partial thromboplastin time and international normalized ratio for various novel anticoagulants.

During studies on warfarin, heparin and various anticoagulants with novel mechanisms of action, the activated partial thromboplastin time (aPTT) and the (apparent) international normalized ratio (INR) from a bedside monitor (Coagucheck Plus(R)) were compared with laboratory assay results. Data were compared using the Bland and Altman method of comparison where systematic differences result in significant slopes of the regression line. During heparin treatment, the bedside monitor largely underestimated the aPTT (slope = -0.80). During treatment with the direct thrombin inhibitor napsagatran (slope = 0.99), the pentasaccharides Org31540/SR90107A (slope = 0.77) and SanOrg34006 (slope = 0.35), and warfarin (slope = 0.60), the bedside monitor underestimated the aPTT at lower aPTT levels, while at higher aPTT levels it overestimated the laboratory values. The bedside monitor slightly overestimated the INR during treatment with warfarin (slope = 0.33). Apparent INR was largely overestimated during treatment with Org31540/SR90107A (slope = 1.38), SanOrg34006 (slope = 0.97), Napsagatran (slope = 1.23), and recombinant tissue factor pathway inhibitor (slope = 1.48, P < 0.001 for all regression lines). These results indicate that a substantial disagreement in aPTT or (apparent) INR exists between the bedside monitor and laboratory assay during treatment with the studied 'classic' and novel anticoagulants. The amount of disagreement depended on the anticoagulant given.

Anticoagulants↗
PubMed2005

Increase in international normalized ratio after smoking cessation in a patient receiving warfarin.

A 58-year-old man who was taking warfarin at a stable dosage was admitted to the hospital with a diagnosis of bacterial meningitis. Although he had previously been a smoker, after this admission, he decided to give up smoking. He was continued on his previous warfarin maintenance dosage when discharged, and his international normalized ratio (INR) soon began to climb substantially. When questioned, the patient reported no diet or lifestyle changes other than his smoking cessation. The patient's INR was stabilized at a warfarin dosage 23% lower than the maintenance dosage before he stopped smoking. This case report illustrates the potential for an interaction between warfarin and cigarette smoking and further suggests that the effect could be significant if a patient starts or stops smoking during warfarin therapy.

Anticoagulants↗
PubMed1997

Medical liability risk avoidance: a case for adopting the International Normalized Ratio (INR) system.

Since bleeding is a common adverse effect associated with the oral anticoagulant warfarin, maximizing the therapeutic potential of this drug requires close laboratory monitoring. The International Normalized Ratio (INR) is a system that has been developed to improve and standardize the assessment of the intensity of oral anticoagulation therapy. Clinical information and medicolegal arguments supporting the adoption of this system are reviewed. The potential for improvement in patient outcomes and minimization of medical liability favors the adoption of the INR system.

Anticoagulants↗
PubMed1994

The correction of coagulometer effects on international normalized ratios: a multicentre evaluation.

One hundred and twenty-nine centres in the U.K. participated in a study to test the reliability of the three methods of correction for coagulometer effects on international normalized ratios (INR). Results from 37 centres which tested three warfarinized plasmas by the manual method were taken as the 'true' INR for the assessment of coagulometers. 63 centres (11 manual and 52 using coagulometers) determined their local International Sensitivity Index (ISI) in a calibration exercise. This was performed with a set of 20 lyophilized plasma calibrants with certified manual prothrombin times for the thromboplastin used in the study. The following methods of INR derivation were compared by assessing the percentage deviation from the three INR values established by 37 manual users: I. No coagulometer correction, i.e. (local PT/reference manual normal PT)manual ISI II. Coagulometer ratio correction, i.e. (local coagulometer PT/local coagulometer MNPT)manual ISI III. Local system ISI, i.e. (local coagulometer PT/local coagulometer MNPT)local system ISI IV. System ISI, i.e. (local coagulometer PT/local coagulometer MNPT)system ISI The local system ISI with the plasma calibrants (method III) gave the most reliable correction (mean deviation from 'true' INR 4.87%). The method which gave the least was with the coagulometer ratio correction, i.e. the manual ISI and local coagulometer MNPT (mean 11.25%). The system ISI tested with ACL coagulometers gave less correction than the local ISI calibration. The local system calibration with lyophilized plasmas also avoids some of the constraints on conventional thromboplastin calibrations.

Calibration↗
PubMed2004

Quality assurance program for whole blood prothrombin time-international normalized ratio point-of-care monitors used for patient self-testing to control oral anticoagulation.

Whole blood coagulation monitors are increasingly used for patient self-testing to control oral anticoagulation, but there are no comprehensive quality assurance (QA) programs to check their performance. We report on the experience with one of such programs applied in a field study where patients on prothrombin time (PT)-international normalized ratio (INR) self-testing were asked to bring their monitors to the anticoagulation clinic for checking. PT-INR testing was performed three times over 3 months with 14 patient's monitors and test strips on three recalcified QA plasmas by an experienced laboratory operator. Each patient was also asked to perform PT-INR self-testing (his/her own capillary blood) which was then compared to the laboratory PT-INR (plasma). Overall, the comparison between the observed and the consensus PT-INR on QA plasmas was acceptable with the majority of measurements lying within +/-15% or 20% of the consensus values. The comparison between the PT-INR self-testing and the laboratory method was also acceptable: overall, there was no statistical significant difference between the mean PT-INR values and the majority of paired measurements were less than 15% or 20% apart. In conclusion, our results show that the proposed QA scheme is feasible and may be implemented on a larger scale. Monitors should be recalled periodically to the clinic where they have been prescribed to the patient. During each visit, the clinic may check the monitors and patient self-testing performance as described. Such comprehensive QA system would make monitoring of oral anticoagulant treatment by self-testing safer and more effective.

Administration, Oral↗
PubMed1997

Warfarin monitoring independent of the international normalized ratio (INR): a pilot study.

Warfarin monitoring is extended to include an anticoagulant therapy factor (ATF). ATF is shown, using four different thromboplastins (Tps), to be comparable with the International Normalized Ratio (INR) mathematically; but ATF is less cumbersome and does not have the INR's poor precision with up to 13.5% error. ATF is formulated from the prothrombin time (PT), fibrinogen transformation rate (FTR) (a representation of thrombin activity), and a consideration of the fibrinogen (FBG) content of blood plasma. Each of these three components is derived from the optical density (O.D.) changes during both the monitoring of the PT and the following FBG-fibrin conversion by a potentiophotometer (PTPH), a linear-reading spectrophotometric device. Comparison of the ATF with the INR shows correlation coefficients of 0.9474, 0.9248, 0.8116 and 0.8603 using the four respective Tps, and the difference against the mean for Bland-Altman plots averages only 0.2 units more for the ATF than the INR. The ATF is independent of the Tp used, and, although Tp affects the PTs, Tp essentially only initiates the tissue factor pathway (TFP) (extrinsic clotting system) to then obtain the PT. It has no rapid direct effect on thrombin activity. For these reasons, in ATF determination, the kind of Tp used is of no consequence. The ATF is independent of the INR, and numerically almost equal to it. The ATF is, therefore, proposed as a replacement for the INR.

Anticoagulants↗
PubMed2005

Transitioning from argatroban to warfarin in heparin-induced thrombocytopenia: an analysis of outcomes in patients with elevated international normalized ratio (INR).

BACKGROUND: Heparin-induced thrombocytopenia (HIT) can lead to catastrophic thromboembolic complications and requires treatment with an alternative, rapidly active anticoagulant, such as a direct thrombin inhibitor (DTI), either to prevent or treat these complications. Switching to oral warfarin after initial treatment with a DTI is necessary in most patients. Most references related to warfarin suggest that an increased risk for bleeding will occur with elevated international normalized ratios (INRs) > 4.6. In patients receiving argatroban, it is not uncommon to achieve an INR > 4 during this transition. Because the clinical outcomes in patients achieving an INR > 4 during combined argatroban/warfarin therapies for HIT are not well described, we evaluated the clinical outcomes of 111 patients with this phenomenon. METHODS: We identified patients from the prospective studies of argatroban anticoagulation, Argatroban-911 and Argatroban-915. Data collected from these studies included death from all causes, amputation, new thrombosis, major bleeding, INR values, argatroban doses, aPTT values, platelet counts, and duration of therapy. RESULTS: Patients were on argatroban monotherapy for a median of 2.8 (0.1-8.1) days, and on cotherapy for a median of 3.7 (0.9-12.8) days. The median platelet count was 70.9 (18-325) x 10(9)/L at the time of HIT diagnosis and increased to 94 (30-324) x 10(9)/L by the time warfarin was initiated. At a median argatroban dose of 1.4 (0.2-2.0) mcg/kg/min, the maximum INR ranged from 4.1 to 21.2 (median 6.4, n = 111) and the corresponding aPTT ranged from 48.1 to 105 (median 71, n = 93) seconds. After argatroban cessation, the first recorded INR within 4 to 24 hours ranged from 1.5 to 12.5 (median 2.9, n = 58). Adverse clinical outcomes occurred in 9 (8.1%) patients during cotherapy and in 12 (10.8%) patients after argatroban anticoagulation was discontinued. Adverse clinical outcomes included 7 cases of new thrombosis, 3 amputations, 12 deaths and 1 major bleed. Eleven of 12 (91.7%) patients died due to causes other than thrombosis, and most deaths (83%) occurred following cotherapy. Five (4.5%) patients developed new thrombosis during argatroban/warfarin cotherapy despite an INR > 4. In contrast only 1 (0.9%) patient experienced major bleeding. CONCLUSION: In patients receiving argatroban/warfarin cotherapy and with an elevated INR > 4, the risk for thrombosis exceeds the risk of bleeding. Traditional paradigms concerning elevated INRs and warfarin may need to be redesigned for the patient population on cotherapy with direct thrombin inhibitors.Abbreviated Abstract. The clinical outcomes of 111 patients with INRs > 4 while on combined argatroban (dose < or = 2 mcg/kg/min) and warfarin were evaluated. Adverse clinical outcomes (7 new thrombosis, 3 amputations, 12 deaths and 1 major bleed) occurred in 21 patients. Eleven deaths were due to causes other than thrombosis. Five patients developed new thrombosis while only 1 had major bleeding. The risk for thrombosis exceeds the risk of bleeding in patients with HIT despite an INR > 4.

Adult↗
PubMed2004

[International normalized ratio in the prothrombin test: clinical significance and use].

The safety and efficiency of therapy by peroral anticoagulants (PA) depend on a laboratory monitoring based on the prothrombin test (PT). The test is distinguished through its variability conditioned by different means of results' presentation as well as through the sensitivity of thromboplastin and a type of a device used in coagulation detection. WHO recommended, 1983, to standardize the thromboplastin preparations through adjusting their sensitivity (the so-called International Sensitivity Index--ISI) to blood coagulation defects induced by PA versus the primary international reference thromboplastin. Thromboplastin ISI as well as the mean normal prothrombin time (MNPT) of blood plasma are used to calculate the international normalized ratio (INR). The presentation of PT results as INR is justified exclusively for the PA-therapy stabilized patients. The INR system makes it possible to optimize the PA therapy only if the laboratory expert and clinician can clearly understand the PT standardization essence and observe the key WHO recommendations, i.e. definition of a coagulometer-specific ISI by manufacturing companies, estimation of MNPT by laboratories and use of the correct anticoagulant concentration.

Humans↗
PubMed2002

Oral vitamin K lowers the international normalized ratio more rapidly than subcutaneous vitamin K in the treatment of warfarin-associated coagulopathy. A randomized, controlled trial.

BACKGROUND: Excessive anticoagulation due to warfarin use is associated with hemorrhage. Subcutaneously administered vitamin K has not been evaluated for the treatment of warfarin-associated coagulopathy, yet it is widely used. OBJECTIVE: To show that oral vitamin K is more effective than subcutaneous vitamin K in the treatment of warfarin-associated coagulopathy. DESIGN: Randomized, controlled trial. SETTING: Two teaching hospitals. PATIENTS: Patients with an international normalized ratio (INR) between 4.5 and 10.0. INTERVENTION: Warfarin therapy was withheld, and 1 mg of vitamin K was given orally or subcutaneously. MEASUREMENTS: The primary outcome measure was the INR on the day after administration of vitamin K. Secondary outcome measures were hemorrhage and thrombosis during a 1-month follow-up period. RESULTS: 15 of 26 patients receiving oral vitamin K and 6 of 25 patients receiving subcutaneous vitamin K had therapeutic INRs on the day after study drug administration (P = 0.015; odds ratio, 4.32 [95% CI, 1.13 to 17.44]). CONCLUSION: Oral vitamin K lowers INR more rapidly than subcutaneous vitamin K in asymptomatic patients who have supratherapeutic INR values while receiving warfarin.

Administration, Oral↗
PubMed2004

Significance of consecutive international normalized ratio (INR) outcomes using statistical control rules in long-term anticoagulated patients. Optimization of laboratory monitoring and interpretation of borderline measurements.

Analysis of serial measurements is needed to elaborate observations in all fields of medical research. In the present study, retrospective data of anticoagulated patients were used to calculate a mean of observations and control limits, X+/-1sigma and X+/-2sigma (mean+/-standard deviation). During 18 months of coagulation monitoring, 45 patients without major oral anticoagulant therapy complications, with more international normalized ratio (INR) determinations in the therapeutic range and with a normal distribution of INR values according to the Kurtosis coefficient, were selected. The cumulative distribution functions allowed us to obtain critical limits of INR with a cumulative probability (p). Control limits, calculated for a therapeutic control chart, indicated through different control rules, 1S2 or 2S1, an alarm signal to analyze the cause of INR outside the therapeutic range. Our investigation suggested that for results at the level of the therapeutic control limits, we needed at least two consecutive INR results to detect a significant over- or under-anticoagulation. The therapeutic control chart method should be a useful means in clinical practice for evaluating the statistical significance of consecutive and borderline INR outcomes. Analytical improvements and control rules applied to laboratory monitoring may help optimize drug dose administration.

Algorithms↗
PubMed1998

[Inter-institute variations in International Normalized Ratio and thrombotest].

Oral anticoagulant therapy is effective for reducing the risk of thromboembolic events in patients with atrial fibrillation or other heart diseases. However, the intensity of oral anticoagulation therapy required in high risk patients, especially in Japanese patients, to achieve the best balance between the prevention of thromboembolic events and bleeding complications remains unclear. The multicenter study of Toyama Warfarin Rational Dosage (TOWARD) was started in 1996 to determine the optimal level of anticoagulant therapy. This study investigated the relationship between values of thrombotest (TT) and International Normalized Ratio (INR) measured from the same samples to clarify inter-institute variations. The relationship between TT and INR was not linear but hyperbolic. Changes of INR to TT are relatively small in the TT range of more than 20% as compared with the range of 20% or less. There were considerable inter-institute variations of TT, and the coefficient of variation (CV) was 0.16 and 0.24 in the low level and high level anticoagulation samples, respectively. However, the variations became significantly small when the same reference was used. The CV of INR was 0.12 and 0.08 in the high level and low level anticoagulation samples, respectively, and very similar with the control samples without anticoagulation (0.11). The variation was small when INR was obtained from the international sensitivity index (ISI) of thromboplastin less than 1.5. TT is widely used for monitoring oral anticoagulant therapy in Japan, and is an excellent system with little inter-institute variation when a standard reference is offered. Since INR has been established as an international monitoring system, the use of INR measured with thromboplastin of small ISI is recommended for monitoring.

Anticoagulants↗
PubMed2003

Increased warfarin doses and decreased international normalized ratio response after nationwide generic switching.

OBJECTIVE: Our objective was to examine possible changes in the effectiveness of warfarin after a nationwide generic substitution of formulations in 1998. METHODS: In the computerized records of a health maintenance organization database, we identified 975 patients who took warfarin continuously over two 6-month periods, before (period 1) and after (period 2) the generic switch. In this sample we performed a retrospective, between-period paired comparison of warfarin doses dispensed and international normalized ratio (INR) levels maintained, as well as of the apparent warfarin sensitivity index (calculated as INR/Warfarin dose [in milligrams per day]). RESULTS: Overall, for period 2, doses were 26.5% higher and INR 4.2% lower, with a 14.7% reduction in warfarin sensitivity index (P <.001). The findings were strongest in the 61 of 975 patients (6.3%) dispensed the lowest maintenance doses (<1.0 mg/d), with minimal change at greater than 3 mg/d. In 94 other patients (9.6%) in whom doses were unchanged, INR (median with 5th and 95th percentiles) dropped to subtherapeutic levels, from 2.2 (1.8, 3.0) to 1.7 (1.3, 1.8) (P <.001). There were no adverse events, expressed as no change in hospital admissions. Apparent warfarin sensitivity was reduced in period 2 by 15% to 20% (P <.001) across all period 1 INR levels. CONCLUSION: Because a general unidirectional change in INR response per unit warfarin dose cannot be explained by biologic mechanisms or confounding, we conclude that slightly reduced bioavailability (within the acceptable bioequivalence range) of the new formulation led to overestimated period 2 doses and reduced apparent warfarin sensitivity in all patient subgroups (by period 1 dose or INR), which was most prominent in those individuals with the lowest maintenance dose requirements.

Anticoagulants↗