Replies to post #648 on SeaStar Medical Holding Corp (ICU)

[Whalatane]

RMB. Well on further DD it looks as tho the interim is based on the first 30 adult patients reaching the 90 day endpt . I'm assuming thats 30 patients on the ICU filter ( vs the 50 I assumed previously )
I can't find any data on the trial design ...re stopping thresholds ...but if they are only looking at 30 patients ...stopping is unlikely due to lack of statistical power .
Statistical power ...my layman's explanation
Flip a coin 10 times and it comes up heads 7 times ...so we assume 70% chance flipping a coin will get you heads each time .
Flip a coin 1,000 times ...and its more 50 / 50 .

If the risk reduction is massive ...like they saw in the pediatric trial ....theres a chance it could be stopped ...or perhaps adding a second interim on 60 patients ( 60 on filter / 60 on SOC ) .

Continuation is most likely unless interim shows pediatric level mortality reduction .

There was a 44% absolute risk reduction and relative risk reduction of 62% of mortality in the pediatric trial ...huge benefit
JMO
Kiwi

[Whalatane]

From an earlier trial

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 .

JMO
Kiwi