Evaluation of the analytical performances of FibWave, a new sensitive tool assessing the fibrin clot formation, to measure the effects of anticoagulants

Abstract

Several in vitro and ex vivo studies have demonstrated the potential of thrombin generation assay (TGA) for the assessment of the effects of direct oral anticoagulants (DOACs) and the monitoring of reversal therapies [ [1] Rigano J. Ng C. Nandurkar H. Ho P. Thrombin generation estimates the anticoagulation effect of direct oral anticoagulants with significant interindividual variability observed. Blood Coagul. Fibrinolysis. 2018; 29: 148-154 Crossref PubMed Scopus (21) Google Scholar ]. Although TGA is a sensitive and global assay, the turn-around time (TAT) and the lack of standardization between the different technologies on the market limit its routine clinical use in patients on anticoagulant therapy [ [2] Tripodi A. Thrombin generation assay and its application in the clinical laboratory. Clin. Chem. 2016; 62: 699-707 Crossref PubMed Scopus (178) Google Scholar ]. TGA estimates the thrombin concentration over-time which is not the final endpoint of the coagulation process. The assessment of fibrin formation by assays and analysers able to visualise the kinetic formation of fibrin clot is therefore of interest to detect coagulation abnormalities beyond thrombin. Usually, traditional clotting assays only report clotting time but many other relevant kinetics parameters have already demonstrated their usefulness in the diagnosis and the prognosis of different coagulation abnormalities [ [3] Lance M.D. A general review of major global coagulation assays: thrombelastography, thrombin generation test and clot waveform analysis. Thromb. J. 2015; 13: 1 Crossref PubMed Scopus (130) Google Scholar ]. The FibWave, a newly developed coagulation assay based on the analysis of the clot formation kinetics, assesses the global coagulation process by measuring changes in turbidity created during the clot formation process. The proof of concept of FibWave has already been demonstrated in procoagulant effects with combined oral contraceptives (COCs) [ [4] Evrard J. Morimont L. Siriez R. Dogne J.-M. Douxfils J. Assessment of the APC Resistance Measured by Thrombin Generation and Clot Waveform Analysis: A Pilot Study. International Society on Thrombosis and Hemostasis (ISTH), Melbourne2019 Google Scholar ]. Nevertheless, the performance of the FibWave has not been tested to assess a haemorrhagic or an anticoagulant tendency, as observed during treatments with DOACs.