Development of the FibWave, an improved clot waveform analysis for the assessment of hemostasis

Résumé

Thromboembolic and hemorrhagic disorders are a global public health problem. Over the last 50 years, research has focused on developing strategies to reduce the mortality and morbidity associated with these diseases. Many studies have been conducted on the assessment of thromboembolic and hemorrhagic risks and the adaptation of patient treatment. In this context, the accessibility of clinical tests is essential to improve the prevention of these disorders.
Currently, many assays, reagents and coagulation analyzers are on the market. Although reagents and assays are readily available, they display various sensitivities. The sensitivity of the reagents depends on the composition of the reagent including the type of activator, the origin and composition of the phospholipids. For coagulation tests, turbidimetry or mechanical detection, viscoelastometry, resonance, visual or fluorometric monitoring are part of the methods available in the laboratory.
The present PhD thesis describes different global hemostasis assays and their potential in clinical applications. Based on some coagulation assays, we aimed to develop a new coagulation method evaluating the fibrin formation kinetics. The method, named the FibWave, allows assessing the global coagulation process by measuring turbidity changes during the fibrin clot formation. An idea of the clot waveform can be depicted in real time and, in addition to obtaining a clotting time, additional coagulation parameters can be extracted.
A detailed description of four global hemostasis assays such as the clot waveform analysis (CWA), global hemostasis potential (OHP), thrombin generation assay (TGA), and viscoelastic methods will be introduced. Then, a description of the FibWave and a proof of concept in procoagulant and anticoagulant states will be provided. Finally, the perspectives according to the new in vitro diagnostic medical devices regulation (IVDR) as well as the validation and standardization of FibWave will be discussed.

la date de réponse	11 avr. 2023
langue originale	Anglais
L'institution diplômante	Universite de Namur
Superviseur	Jonathan Douxfils (Promoteur), Jean-Michel Dogne (Copromoteur), Stephane Lucas (Jury), Bernard Masereel (Jury), Francois Mullier (Jury), Fabian Demeure (Jury), Peter B. Verhamme (Jury), Hugo TEN CATE (Jury) & Aurélien Lebreton (Jury)