Standardization of bleeding time by IVY method in male Japanese healthy volunteers

PURPOSE: In the development of new antithrombotic agents, the bleeding time has been used to evaluate the anti-hemostatic effects and predict the bleeding tendency. The Simplate bleeding time method (SIMP) has so far been used worldwide. However, the production of Simplate has been ceased. In this study, we introduced a new method which applies a thin taper needle to bleeding time measurement (IVY). There is no fundamental data of IVY in Japanese and the characters of two methods have never been compared in Japanese subjects. The purpose of this study is to find the standard values of bleeding time using IVY in 120 Japanese healthy male subjects and compare the inter-operator and inter-subject variability of IVY and SIMP. METHODS: In 120 subjects, bleeding time was measured by 1 operator using two different implements for IVY. In 6 volunteers, bleeding time was measured by 3 different operators using IVY and SIMP. RESULTS: The standards of bleeding time using IVY were 1'13"-2'44" (mean1'58" +/- 2SD, n = 117) by Glucoject Plus 2 and 1'4"-2'47" (mean1'56" +/- 2SD, n = 116) by auto-Lancet II. Average values by IVY were consistent, 1.8, 1.8 and 1.9 minutes among 3 operators. The corresponding values by SIMP were inconsistent, 5.3, 6.8 and 9.2 minutes. Bleeding time values measured by IVY were stable and consistent among subjects compared with values obtained by SIMP. CONCLUSION: The standard of bleeding time using IVY and less inter-operator and -subject variability of IVY were shown in this study. IVY might replace SIMP for measuring bleeding time.