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Biotech / Medical : Biotime-Nasdaq's best kept secret? -- Ignore unavailable to you. Want to Upgrade?

To: Jim Roof who wrote (940)	5/15/1998 10:21:00 AM
From: Stephen How	Read Replies (1) \| Respond to of 1432

How can you be so sure that your interpretation of the data is correct since according to your arguments [ ... ] the data itself is not broad enough to draw any conclusions? I didn't say the data doesn't allow for conclusions. I'm saything the data does not allow for the conclusion that Hextend&reg is better than hetastarch. I'm saying that the data shows that Hextend&reg is no better than hetastarch, i.e., the differences are not statistically significant. My conclusion is also based on the understanding of hetastarch induced coagulopathy (non-dilutional effect on Factor VIII), and the dilutional effects on clotting factors (Ca++, e.g.). I don't believe there's a simple fix to the hetastarch effect on clotting factor VIII. I understand that the clotting factors (factor VIII, Ca++, platelets) are supplemented by administering FFP in large volume replacement cases, and electrolytes and acid-base are monitored and treated intraoperatively. The mean differences in the Phase III results are not significant, and the means themselves are very small, and the SD are high. The EBL mean for the hetastarch group is 1.3 L and the SD is 1.6 L. The difference to the Hextend&reg group is .25L, or .16 SD. Note that the SD is larger than the mean. The SD for crystalloids is 2.5 times the mean! The difference between the two groups is .06 SD. The RBC numbers are very similar to the crystalloid numbers, and should be unrelated to coagulation anyways! (it's more a function of O2 transport). The remaining metrics are very small -- FFP applied for the hetastarch group is .122 L (1/4 unit), while the SD is 4 times the mean. Almost no platelets or cryoprecipitate were used in either group. I would expect the results to be statistically equivalent, because I understand that doctors monitor and administer Ca++ intraoperatively anyways (see Table 4 of Phase III report).