Interlaboratory variation in heparin monitoring: Lessons from the Quality Management Program of Ontario coagulation surveys

Cuker, Adam; Raby, Anne; Moffat, Karen A.; Flynn, Greg; Crowther, Mark

doi:10.1160/th10-02-0099

Cited by 24 publications

(14 citation statements)

References 24 publications

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“…Studies evaluating inter-laboratory agreement in the context of heparin monitoring have failed to show that aPTT results correlate with anti-Xa results between different hospital laboratories. Moreover, greater variation was generally observed in the anti-Xa assay compared with the aPTT test [ 10 11 ]. Variations in anti-Xa measurements are observed when sample processing is delayed, as PF4 neutralizes heparin [ 12 ].…”

Section: Discussionmentioning

confidence: 99%

Establishing the heparin therapeutic range using aPTT and anti-Xa measurements for monitoring unfractionated heparin therapy

et al. 2016

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BackgroundUnfractionated heparin (UFH) has unstable pharmacokinetics and requires close monitoring. The activated partial thromboplastin time (aPTT) test has been used to monitor UFH therapy for decades in Korea, but its results can be affected by numerous variables. We established an aPTT heparin therapeutic range (HTR) corresponding to therapeutic anti-Xa levels for continuous intravenous UFH administration, and used appropriate monitoring to determine if an adequate dose of UFH was applied.MethodsA total of 134 ex vivo samples were obtained from 71 patients with a variety of thromboembolisms. All patients received intravenous UFH therapy and were enrolled from June to September 2015 at Gyeongsang National University Hospital. All laboratory protocols were in accordance with the Clinical and Laboratory Standards Institute guidelines and the College of American Pathologist requirements for aPTT HTR.ResultsAn aPTT range of 87.1 sec to 128.7 sec corresponded to anti-Xa levels of 0.3 IU/mL to 0.7 IU/mL for HTR under our laboratory conditions. Based on their anti-Xa levels, blood specimen distribution were as follows: less than 0.3 IU/mL, 65.7%; 0.3–0.7 IU/mL (therapeutic range), 33.6%; and more than 0.7 IU/mL, 0.7%. No evidence of recurring thromboembolism was observed.ConclusionUsing the conventional aPTT target range may lead to inappropriate dosing of UFH. Transitioning from the aPTT test to the anti-Xa assay is required to avoid the laborious validation of the aPTT HTR test, even though the anti-Xa assay is more expensive.

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Section: Discussionmentioning

confidence: 99%

Establishing the heparin therapeutic range using aPTT and anti-Xa measurements for monitoring unfractionated heparin therapy

et al. 2016

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“…In response to the numerous limitations of the aPTT, researchers have evaluated direct heparin concentration monitoring using heparin anti-Xa levels. Compared to the aPTT, the heparin anti-Xa level is less impacted by biologic variables, but pre-analytic and analytic variability remain and can be considerable [ 19 ]. The anti-Xa is also more expensive than the aPTT, and is both less available and less familiar to clinicians.…”

Section: Guidancementioning

confidence: 99%

Guidance for the practical management of the heparin anticoagulants in the treatment of venous thromboembolism

Smythe

Priziola

Dobesh

et al. 2016

J Thromb Thrombolysis

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188

183

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Venous thromboembolism (VTE) is a serious and often fatal medical condition with an increasing incidence. Despite the changing landscape of VTE treatment with the introduction of the new direct oral anticoagulants many uncertainties remain regarding the optimal use of traditional parenteral agents. This manuscript, initiated by the Anticoagulation Forum, provides clinical guidance based on existing guidelines and consensus expert opinion where guidelines are lacking. This specific chapter addresses the practical management of heparins including low molecular weight heparins and fondaparinux. For each anticoagulant a list of the most common practice related questions were created. Each question was addressed using a brief focused literature review followed by a multidisciplinary consensus guidance recommendation. Issues addressed included initial anticoagulant dosing recommendations, recommended baseline laboratory monitoring, managing dose adjustments, evidence to support a relationship between laboratory tests and meaningful clinical outcomes, special patient populations including extremes of weight and renal impairment, duration of necessary parenteral therapy during the transition to oral therapy, candidates for outpatient treatment where appropriate and management of over-anticoagulation and adverse effects including bleeding and heparin induced thrombocytopenia. This article concludes with a concise table of clinical management questions and guidance recommendations to provide a quick reference for the practical management of heparin, low molecular weight heparin and fondaparinux.

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“…A French study has recently shown a 3 to 8 fold aPTT increase for an anti-Xa activity of 0.7 IU/mL (Table 1 ) [ 80 ]. Too sensitive reagents do not allow a precise chronometric measurement and therefore should not be used for UFH monitoring [ 81 , 82 ]. In addition, mechanical end point coagulometers showed greater sensitivity than optical ones [ 83 ].…”

Section: Biological Monitoring Of Anticoagulant Treatmentsmentioning

confidence: 99%

“…Similar reagent/instrument combinations showed less variation in aPTT results than unlike combinations [ 82 ]. Using the same instrument model and same reagent lot but performed in different laboratories, significant statistical and clinical differences in the heparin therapeutic range values are found, owing to variation in the individual plasma samples as well as pre-analytical and analytical variables that can vary greatly between hospitals.…”

Section: Biological Monitoring Of Anticoagulant Treatmentsmentioning

confidence: 99%

Measurement of non-VKA oral anticoagulants versus classic ones: the appropriate use of hemostasis assays

et al. 2014

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Traditional anticoagulant agents such as vitamin K antagonists (VKAs), unfractionated heparin (UFH), low molecular weight heparins (LMWHs) and fondaparinux have been widely used in the prevention and treatment of thromboembolic diseases. However, these agents are associated with limitations, such as the need for regular coagulation monitoring (VKAs and UFH) or a parenteral route of administration (UFH, LMWHs and fondaparinux).Several non-VKA oral anticoagulants (NOACs) are now widely used in the prevention and treatment of thromboembolic diseases and in stroke prevention in non-valvular atrial fibrillation. Unlike VKAs, NOACs exhibit predictable pharmacokinetics and pharmacodynamics. They are therefore usually given at fixed doses without routine coagulation monitoring. However, in certain patient populations or special clinical circumstances, measurement of drug exposure may be useful, such as in suspected overdose, in patients experiencing a hemorrhagic or thromboembolic event during the treatment’s period, in those with acute renal failure, in patients who require urgent surgery or in case of an invasive procedure. This article aims at providing guidance on laboratory testing of classic anticoagulants and NOACs.Electronic supplementary materialThe online version of this article (doi:10.1186/1477-9560-12-24) contains supplementary material, which is available to authorized users.

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Interlaboratory variation in heparin monitoring: Lessons from the Quality Management Program of Ontario coagulation surveys

Cited by 24 publications

References 24 publications

Establishing the heparin therapeutic range using aPTT and anti-Xa measurements for monitoring unfractionated heparin therapy

Establishing the heparin therapeutic range using aPTT and anti-Xa measurements for monitoring unfractionated heparin therapy

Guidance for the practical management of the heparin anticoagulants in the treatment of venous thromboembolism

Measurement of non-VKA oral anticoagulants versus classic ones: the appropriate use of hemostasis assays

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