Utilization of international normalized ratio-derived formula to predict plasma rivaroxaban level—Validation study and real-world experience

IF 2.2 4区医学 Q3 HEMATOLOGY

International Journal of Laboratory Hematology Pub Date : 2024-07-17 DOI:10.1111/ijlh.14347

Chun-fun Sin, Ka-ping Wong, Chun Wah Siu, Tsz-fu Wong, Hoi-man Wong

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引用次数: 0

Abstract

Introduction

Specific assays of plasma rivaroxaban level are not always readily available with short turnaround time, which hamper the management of urgent clinical situations. In this study, we aimed to build a predictive formula of plasma rivaroxaban levels from international normalized ratio (INR) value and validated in real world clinical situations.

Methods

Ninety-four patients who were taking rivaroxaban participated in the study. Patients were randomized into testing cohort and validation cohorts. The prediction formula was built from the testing cohort and then validated in validation cohort. The predictive performance was further validated on real-world clinical requests.

Results

The root mean square error (RMSE) of the predictive formula for the testing and validation cohorts were 61.81 and 69.32 ng/mL, respectively. The sensitivity and specificity for the formula to predict the threshold plasma rivaroxaban level of 75 ng/mL were 95% (95% CI: 85.4%–100%) and 87.5% (95% CI: 71.3%–100%), respectively, in real-world clinical situations.

Conclusion

Plasma rivaroxaban level of threshold level of 75 ng/mL can be calculated from prediction formula by INR value with satisfactory accuracy and it can be used to guide the decision for reversal.

Abstract Image

查看原文本刊更多论文

利用国际正常化比率公式预测血浆利伐沙班水平--验证研究和实际经验。

简介：血浆利伐沙班水平的特异性检测方法并非总能在短时间内获得，这妨碍了对紧急临床情况的处理。本研究旨在根据国际正常化比值（INR）建立血浆利伐沙班水平的预测公式，并在实际临床情况中进行验证：94名服用利伐沙班的患者参与了研究。患者被随机分为测试组和验证组。根据测试组群建立预测公式，然后在验证组群中进行验证。在真实世界的临床要求中进一步验证了预测性能：结果：测试组和验证组预测公式的均方根误差（RMSE）分别为 61.81 和 69.32 纳克/毫升。在实际临床情况下，该公式预测血浆利伐沙班阈值水平为75纳克/毫升的灵敏度和特异度分别为95%（95% CI：85.4%-100%）和87.5%（95% CI：71.3%-100%）：结论：血浆利伐沙班水平的阈值为75纳克/毫升，可以通过INR值的预测公式计算出，准确性令人满意，可用于指导逆转的决策。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Laboratory Hematology 医学-血液学

CiteScore

4.50

自引率

6.70%

发文量

211

审稿时长

6-12 weeks

期刊介绍： The International Journal of Laboratory Hematology provides a forum for the communication of new developments, research topics and the practice of laboratory haematology. The journal publishes invited reviews, full length original articles, and correspondence. The International Journal of Laboratory Hematology is the official journal of the International Society for Laboratory Hematology, which addresses the following sub-disciplines: cellular analysis, flow cytometry, haemostasis and thrombosis, molecular diagnostics, haematology informatics, haemoglobinopathies, point of care testing, standards and guidelines. The journal was launched in 2006 as the successor to Clinical and Laboratory Hematology, which was first published in 1979. An active and positive editorial policy ensures that work of a high scientific standard is reported, in order to bridge the gap between practical and academic aspects of laboratory haematology.