A Modified Viscoelastic Point-of-Care Method for Rapid Quantitative Detection of Enoxaparin: A Single-Centre Observational Study

TL;DR

This study introduces a quick and reliable point-of-care method to measure enoxaparin levels in patients, helping guide clinical decisions in urgent situations.

Contribution

A modified viscoelastic method using RVV clotting time ratios for rapid enoxaparin detection is proposed and validated.

Findings

The RVV CT ratio showed strong correlation with anti-Xa activity (r = 0.774, p < 0.001).

Cut-off values of 1.02, 1.23, and 1.6 for RVV CT ratios effectively distinguish anti-Xa activity levels.

The method provides semi-quantitative results within 10 minutes in real clinical settings.

Abstract

Background: Laboratory monitoring of the effect of low-molecular-weight heparins (LMWHs) is generally not necessary. However, prompt evaluation of heparin inhibitory effects (i.e., anti-Xa activity) is important in cases of life-threatening bleeding, need for urgent surgery or acute thromboembolism under LMWH treatment. We aimed to establish a simple and reliable point-of-care method for the detection of enoxaparin. Methods: Eighty patients under enoxaparin therapy and ten healthy volunteers without any anticoagulant treatment were enrolled. Simultaneous measurements of anti-Xa activity using the chromogenic method and clotting times in the absence and presence of polybrene using viscoelastometric assays containing Russell’s viper venom (RVV-test) were performed on the ClotPro device. Results: Among the measured and derived RVV-test parameters, the ratio of the RVV clotting times (RVV CT) detected in the absence and presence of polybrene showed the best statistically significant correlation with anti-Xa activity (r = 0.774, p < 0.001). Based on ROC analysis, we designated RVV CT ratios of 1.02, 1.23 and 1.6 as the best cut-off values for separating anti-Xa ranges below and above 0.3 and 0.6 IU/mL, respectively. If the RVV CT ratio is below or above 1.23, the anti-Xa activity is suggested to be below 0.6 IU/mL or above 0.3 IU/mL with high certainty, respectively. Further differentiation is possible if the RVV CT ratio is measured below 1.02 or above 1.6. In these cases, the measured anti-Xa values are below 0.3 IU/mL or above 0.6 IU/mL, respectively, with high probability and good predictive values. Conclusions: Our method can provide semiquantitative information on the effect of enoxaparin and the expected anti-Xa activity within 10 min in real clinical situations.

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