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Impact of direct oral anticoagulants on ROTEM® variables; a sample size-calculated experimental study
Lotta Sunnersjö1,2, Lukas Lindquist2, Ulf Schött2,3
1Department of Intensive and Perioperative Care, Skåne University Hospital, Malmö, Sweden.
Scandinavian Journal of Clinical and Laboratory Investigation
|December 14, 2024
Summary
Direct oral anticoagulants (DOACs) are linked to bleeding risks. Rotational thromboelastometry (ROTEM) shows promise in monitoring these drugs, with clotting time (CT) increasing alongside DOAC concentrations, suggesting ROTEM can indicate drug levels.
Area of Science:
- Pharmacology
- Hematology
- Clinical Diagnostics
Background:
- Direct oral anticoagulants (DOACs) are widely used for anticoagulation.
- Bleeding complications are a concern with elevated DOAC plasma concentrations.
- Rotational thromboelastometry (ROTEM) is a point-of-care test assessing hemostasis that may correlate with DOAC levels.
Purpose of the Study:
- To investigate the impact of increasing rivaroxaban concentrations on Rotational thromboelastometry (ROTEM) EXTEM assay clotting time (CT).
- To examine the effects of rivaroxaban, dabigatran, and apixaban on ROTEM parameters like CT, clot formation time (CFT), and alpha-angle (AA).
Main Methods:
- Blood from 12 healthy volunteers was spiked with varying concentrations (0-1000 µg/L) of rivaroxaban, dabigatran, and apixaban.
- Spiked blood samples were analyzed using four different ROTEM assays.
- Clotting time (CT), clot formation time (CFT), and alpha-angle (AA) were measured.
Main Results:
- Clotting time (CT) increased linearly with rising concentrations of all three DOACs.
- Elevated CT in EXTEM assay was observed for rivaroxaban and dabigatran at 200-1000 µg/L, and for apixaban at 500-1000 µg/L.
- Clot formation time (CFT) and alpha-angle (AA) were significantly affected only at supratherapeutic DOAC concentrations, primarily in the INTEM assay. Apixaban showed the least impact on CT.
Conclusions:
- ROTEM-derived clotting time (CT) measurements correlate with direct oral anticoagulant (DOAC) concentrations.
- ROTEM assays, particularly CT, may serve as surrogate markers for monitoring DOAC levels in clinical practice.
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