Pierre Fontana1, Lorenzo Alberio2, Anne Angelillo-Scherrer3, Lars M Asmis4, Wolfgang Korte5, Adriana Mendez6, Pirmin Schmid7, Hans Stricker8, Jan-Dirk Studt9, Dimitrios A Tsakiris10, Walter A Wuillemin11, Michael Nagler12. 1. Division of Angiology and Haemostasis, Laboratory of Haemostasis, University Hospitals of Geneva, CH-1211 Geneva, Switzerland. 2. Service and Central Laboratory of Haematology, Centre Hospitalier Universitaire Vaudois, University of Lausanne, CH-1011 Lausanne, Switzerland. 3. Department of Haematology, Inselspital, Bern University Hospital, Department of Clinical Research, University of Bern, CH-3010 Berne, Switzerland. 4. Unilabs Zurich, CH-8034 Zurich, Switzerland. 5. Institute for Clinical Chemistry and Haematology, Cantonal Hospital St. Gallen, CH-9007 St. Gallen, Switzerland. 6. Center for Laboratory Medicine, Cantonal Hospital Aarau, CH-5001 Aarau, Switzerland. 7. Division of Haematology, Central Haematology Laboratory, Luzerner Kantonsspital, CH-6000 Lucerne 16, Switzerland. 8. Division of Surgery, Regional Hospital La Carita, CH-6600 Locarno, Switzerland. 9. Division of Haematology, University Hospital and University of Zurich, CH-8091 Zurich. 10. Diagnostic Haematology, University Hospital of Basel, CH-4031 Basel, Switzerland. 11. Division of Haematology, Central Haematology Laboratory, Luzerner Kantonsspital, CH-6000 Lucerne 16, Switzerland; Department of Clinical Research, University of Berne, CH-3000 Berne, Switzerland. 12. Department of Haematology, Inselspital, Bern University Hospital, Department of Clinical Research, University of Bern, CH-3010 Berne, Switzerland; Department of Clinical Research, University of Berne, CH-3000 Berne, Switzerland. Electronic address: michael.nagler@insel.ch.
Abstract
BACKGROUND: Point-of-care testing (POCT) is regularly used to assess haemostasis in various clinical settings. The impact of rivaroxaban on those POCT is still elusive. We aimed to study the effects of rivaroxaban on most commonly used POCT assays. METHODS: Blood samples were taken before, 3h, and 24h after administration of 20mg rivaroxaban to 20 healthy volunteers as part of a prospective, multicenter validation study (clinicaltrials.govNCT01710267). Blood samples were analysed with thromboelastometry (ROTEM®), two platelet function assays (INNOVANCE® PFA-200 and Multiplate®), and the CoaguChek® XS. Rivaroxaban plasma levels were determined using liquid chromatography-mass spectrometry. RESULTS: Rivaroxaban significantly modified some thromboelastometry parameters (CT INTEM: mean difference 56.1s, 95% CI: 41.8, 70.3; CT EXTEM: 47.5s, 95% CI: 37.8, 57.1; CT HEPTEM: 50.1s, 95% CI: 34.7, 65.6), and CoaguChek® XS parameters (prothrombin time: mean difference 3.8s, 95% CI: 3.3, 4.2; INR: 0.32, 95% CI: 0.27, 0.38; prothrombin ratio: -36.1%, 95% CI: -32.3, -39.9). CT EXTEM and INR showed a moderate correlation with rivaroxaban plasma levels (r=0.83; 95% CI 0.69, 0.9 and r=0.83; 95% CI 0.70, 0.91, respectively) and a high sensitivity to detect rivaroxaban treatment at peak levels (0.95; 95% CI: 0.76, 1.0 and 0.90, 95% CI 0.70, 0.99, respectively). CONCLUSIONS: Rivaroxaban 20mg treatment significantly alters ROTEM® and CoaguChek® XS parameters. Even though POCT do not allow precise quantification of rivaroxaban plasma concentration, CT EXTEM and CoaguChek XS detect the presence of rivaroxaban at peak level with a high sensitivity.
BACKGROUND: Point-of-care testing (POCT) is regularly used to assess haemostasis in various clinical settings. The impact of rivaroxaban on those POCT is still elusive. We aimed to study the effects of rivaroxaban on most commonly used POCT assays. METHODS: Blood samples were taken before, 3h, and 24h after administration of 20mg rivaroxaban to 20 healthy volunteers as part of a prospective, multicenter validation study (clinicaltrials.govNCT01710267). Blood samples were analysed with thromboelastometry (ROTEM®), two platelet function assays (INNOVANCE® PFA-200 and Multiplate®), and the CoaguChek® XS. Rivaroxaban plasma levels were determined using liquid chromatography-mass spectrometry. RESULTS:Rivaroxaban significantly modified some thromboelastometry parameters (CT INTEM: mean difference 56.1s, 95% CI: 41.8, 70.3; CT EXTEM: 47.5s, 95% CI: 37.8, 57.1; CT HEPTEM: 50.1s, 95% CI: 34.7, 65.6), and CoaguChek® XS parameters (prothrombin time: mean difference 3.8s, 95% CI: 3.3, 4.2; INR: 0.32, 95% CI: 0.27, 0.38; prothrombin ratio: -36.1%, 95% CI: -32.3, -39.9). CT EXTEM and INR showed a moderate correlation with rivaroxaban plasma levels (r=0.83; 95% CI 0.69, 0.9 and r=0.83; 95% CI 0.70, 0.91, respectively) and a high sensitivity to detect rivaroxaban treatment at peak levels (0.95; 95% CI: 0.76, 1.0 and 0.90, 95% CI 0.70, 0.99, respectively). CONCLUSIONS:Rivaroxaban 20mg treatment significantly alters ROTEM® and CoaguChek® XS parameters. Even though POCT do not allow precise quantification of rivaroxaban plasma concentration, CT EXTEM and CoaguChek XS detect the presence of rivaroxaban at peak level with a high sensitivity.
Authors: Vepusha Sathanantham; Lorenzo Alberio; Cédric Bovet; Pierre Fontana; Bernhard Gerber; Lukas Graf; Adriana Mendez; Thomas C Sauter; Adrian Schmidt; Jan-Dirk Studt; Walter A Wuillemin; Michael Nagler Journal: Life (Basel) Date: 2022-07-11
Authors: Sebastian D Sahli; Julian Rössler; David W Tscholl; Jan-Dirk Studt; Donat R Spahn; Alexander Kaserer Journal: Sensors (Basel) Date: 2020-07-30 Impact factor: 3.576