l Reduced Mortality: In one prospective study comparing 12 patients treated with SCD to historical case-matched controls, the mortality in the SCD group was significantly lower (22% vs. 78%, p = 0.03). Treatment with SCD was identified as the only significant variable impacting mortality in a multivariate regression analysis.
So mortality rate for those using ICU's filter was only 22% vs the historical SOC of 78% ...! Thats a huge difference ...limitation is very small number and a P value of .03 DSMB would probably want a P value of at least .01 with similar mortality reduction numbers to stop the trial .
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