Falsely Elevated International Normalized Ratio Values in Patients Undergoing Anticoagulation Therapy

Delate, Thomas; Witt, Daniel M.; Jones, Jared R.; Bhardwaja, Bharati; Senser, Martin

doi:10.1378/chest.06-2200

Cited by 18 publications

(11 citation statements)

References 8 publications

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“…Prior studies have demonstrated the ability of CFX to remain unaffected by the presence of lupus anticoagulant and other variables that affect clottable assays [1][2][3][4][5][6][7]. Furthermore, CFX has proven useful in monitoring for therapeutic anticoagulation when converting from argatroban to warfarin.…”

Section: Discussionmentioning

confidence: 99%

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

McGlasson¹,

Romick²,

Rubal³

2008

Blood Coagulation & Fibrinolysis

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The purpose of the present study was to compare the international normalized ratio with a chromogenic factor X (CFX) assay for monitoring patients on oral anticoagulant therapy using the DiaPharma CFX method on a STA-R Evolution coagulation analyzer. International normalized ratio values were correlated with the CFX for determining normal, subtherapeutic, therapeutic and supratherapeutic ranges for these patients. Specimens were analyzed and grouped as normal or patients on oral anticoagulant therapy with international normalized ratios of less than 2.0, 2.0-3.0, and more than 3.0. Three hundred and nine randomly selected oral anticoagulant therapy patients were tested. The range of international normalized ratio and CFX in oral anticoagulant therapy patients was 0.92-12.76 and 9-132%, respectively. CFX was inversely related to international normalized ratio; R = 0.964 (P < 0.0001) (CFX = 13.2 + (5.3/international normalized ratio) + (81.3/international normalized ratio). Results by group were as follows: normal (n = 30), CFX range 72-131%, mean CFX 96%; international normalized ratio less than 2.0 (n = 70), CFX range 32-132%, mean CFX 53%; international normalized ratio 2.0-3.0 (n = 135), CFX range 18-48%, mean CFX 28%; international normalized ratio more than 3.0 (n = 104), CFX range 9-46%, mean CFX 21%. Sensitivity and specificity crossed at a CFX of 35.5%, which yielded a sensitivity of 91.7% and a specificity of 91.9% for discriminating international normalized ratio of at least 2.0. Area under the curve on receiver-operator curve using international normalized ratio was 0.984 (P < 0.001). In this randomly selected group of oral anticoagulant therapy patients and normal individuals at varying levels of anticoagulation, CFX correlated well with international normalized ratio as determined by R = 0.964. The data suggests that the CFX can be a useful tool for monitoring oral anticoagulation in patient populations in which confounders to international normalized ratio may be present. Further investigation with the use of CFX for monitoring is warranted in large patient populations on oral anticoagulant therapy, including follow-up for clinical outcomes.

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Section: Discussionmentioning

confidence: 99%

“…However, INR values may be affected by the presence of lupus anticoagulant and other clinical and preanalytical variables [1,2]. This is especially true when the international sensitivity indices (ISI) of the thromboplastins have not been locally calibrated with the specific instrument combinations used in the testing facility [3][4][5].…”

Section: Introductionmentioning

confidence: 99%

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

McGlasson¹,

Romick²,

Rubal³

2008

Blood Coagulation & Fibrinolysis

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“…Until then, warfarin must be used carefully in dialysis patients with AF. False elevations of the PT‐INR are observed frequently during dialysis, and they are reportedly caused by inappropriate blood sampling using an indwelling catheter (20). We recommend that blood used for the determination of PT‐INR be collected directly from a blood vessel.…”

Section: Sudden Cardiac Death and Arrhythmiasmentioning

confidence: 99%

Japanese Society for Dialysis Therapy Guidelines for Management of Cardiovascular Diseases in Patients on Chronic Hemodialysis

et al. 2012

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“…In addition to their known uremic platelet dysfunction, many patients have cardiovascular risk factors or indications for antiplatelet medications, both of which may increase their risk for bleeding with anticoagulation therapy . International Normalized Ratio (INR) results may be fluctuant and unpredictable in ESRD on hemodialysis and time in therapeutic range is poor . The aforementioned dilemmas underscore a need for additional anticoagulation options in ESRD patients on hemodialysis.…”

Section: Introductionmentioning

confidence: 99%

Safety and effectiveness of apixaban compared to warfarin in dialysis patients

Reed

Palkimas

Hockman

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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Essentials The safety of apixaban in patients on dialysis is currently debated.Bleeding events were retrospectively compared for dialysis patients on warfarin vs apixaban.Overall bleeding events were significantly less frequent in apixaban group compared to warfarin group.Apixaban appears to be a safe and effective choice for anticoagulation in patients on dialysis. BackgroundThe use of apixaban for stroke prophylaxis or for the treatment of venous thromboembolism in end stage renal disease (ESRD) patients maintained on dialysis is based on one single‐dose pharmacokinetic study. There is a deficiency of clinical evidence supporting safety in this population.ObjectiveThe purpose of this study was to determine the safety and efficacy of apixaban compared with warfarin in dialysis patients.Patients/methodsThis is a retrospective cohort study conducted at the University of Virginia Medical Center. A total of 124 ESRD patients maintained on dialysis who either received apixaban (n = 74) or warfarin (n = 50) between January 1, 2014 and October 31, 2016 were included in the study. We used multivariable logistic regression to compare the likelihood of patients experiencing a bleeding event based on anticoagulant therapy.ResultsThe apixaban group experienced fewer overall bleeding events than the warfarin group (18.9% vs 42.0%; P = .01); this significant difference persisted in adjusted analysis (OR = 0.15; 95% CI = 0.05‐0.46; P = .001). Major bleeding events were less frequent in the apixaban group compared with patients on warfarin (5.4% vs 22.0%; P = .01). There were no recurrent ischemic strokes in either groups. A lower, non‐significant, incidence of recurrent VTE was found in patients on apixaban compared with warfarin (4.4% vs 28.6%; P = .99).ConclusionCompared to warfarin, our findings suggest that apixaban is a safe and effective alternative in patients with ESRD maintained on dialysis, with apixaban patients experiencing fewer bleeding events than warfarin patients.

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Falsely Elevated International Normalized Ratio Values in Patients Undergoing Anticoagulation Therapy

Cited by 18 publications

References 8 publications

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

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

Japanese Society for Dialysis Therapy Guidelines for Management of Cardiovascular Diseases in Patients on Chronic Hemodialysis

Safety and effectiveness of apixaban compared to warfarin in dialysis patients

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