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"Samples spiked with a factor Xa inhibitor in vitro.

'Maximum change in prothrombin time compared to 0.98 ISI human recombinant thromboplastin. 'Variability of three increasing ISI levels of rabbit brain thromboplastin compared to human recombinant.

"Samples spiked with a factor Xa inhibitor in vitro.

'Maximum change in prothrombin time compared to 0.98 ISI human recombinant thromboplastin. 'Variability of three increasing ISI levels of rabbit brain thromboplastin compared to human recombinant.

control ratio could be used effectively to normalize thromboplastin differences in untreated human, dog, or rat samples. At predicted efficacious concentrations of FXa inhibitor, the PT/control ratio effectively normalized reagent differences. However, at high concentrations of FXa inhibitor, particularly in the rat, this method lacked the ability to normalize results effectively.

Table 4 shows the corresponding INR values obtained in human, dog, and rat plasma when assessed with rabbit brain thromboplastins of increasing ISI. As anticipated, the PT/control ratio and INR were similar when the ISI was approximately 1. In contrast to the modest differences in PT when expressed as either absolute seconds or as a ratio compared to control value, the INR showed dramatic increases (Table 3). The magnitude of the INR value rose consistently with increasing ISI value and was marked. At the highest dose tested, the INR ranged from 11.1 with the 0.98 ISI reagent to 121.9 with the 2.21 ISI reagent in human samples, 5.6 to 43.4 in dogs, and 4.6 to 48.1 in rats. Assessment of PT in human, dog, or rat plasma containing this developmental FXa inhibitor was affected by the ISI of the thromboplastin selected for the

TABLE 3 In Vitro Effect of an Experimental Factor Xa Inhibitor on Prothrombin Time/Control Ratio Using a Rabbit Brain Thomboplastin

_ _ International Sensitivity Index" Concentration of Factor ___

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