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As the primary endpoint of the study, data on the changes in the severity of hemorrhage after Futhan-used hemodialysis showed that of 49 subjects, reduced and no-change hemorrhages was reported by 35 and 14, respectively, thus representing 100% efficacy (PP analysis). In the ITT analysis, the increased severity of hemorrhage in 54 subjects was not observed and thus the same outcome the per-protocol analysis was obtained. After hemodialysis using Futhan and heparin, CCT values did not increase during Futhan-used hemodialysis but with a slight increase during heparin-used hemodialysis. PP analysis showed that there were statistically significant lower residual blood clotting during the first and the second Futhan-used hemodiaylsis, when compared with heparin-used hemodialysis. There was no significant difference of blood clotting in arterial dip-chamber after hemodialysis using Futhan and heparin. In the case of blood clotting in venous drip-chamber that is deemed more important in the efficacy assessments of an anticoagulant, PP analysis showed that there was a statistically lower blood clotting during the third Futhan-used hemodialysis, when compared with heparin-used hemodialysis. The blood clotting during the first and the second Futhan-used hemodialysis were also statistically insignificantly lower than heparin-used hemodialysis. Hemostatic time at puncture site was evaluated for 26 subjects due to the fact that a number of subjects could be evaluated. PP analysis showed that there was no significant difference in hemostatic time between the two drugs. The results of the study demonstrate that Furthan is a safe anticoagulant in patients with hemorrhage during hemodialysis, compared to patients treated with heparin, as Futhan has a comparable or superior anticoagulation effect to heparin without affecting hemorrhage. |
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