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Abstract:
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Hemostasis evaluations are commonly used to assess clinical conditions in trauma, cardiovascular surgery and it is also used in cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. Clotting time, clot stiffness/firmness, and platelet function are parameters for evaluating whether the new device is substantial equivalence to an already marketed device. Although these parameters are semi-quantitative, if the units are different between devices due to using different techniques to measure these parameters, regression analysis is not an appropriate method to use. In this paper, a simulated data was used to determine whether ordinary regression analysis with rank-based transferred data can be a possible analysis option in evaluating hemostasis state of a blood sample.
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