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Wed Oct 7 23:37:35 BST 2009

Ken
I have to disagree with you.  The two papers presented were registry
analyses.  They were well-designed registry analyses but fundamentally
that's all they were.  The only real conclusions to take away from them is
that Factor VII has been used in patients and that rF7a appears safe.  The
rest is open to bias, confounders, missing patients etc etc etc and no real
information about utility can be made.

The results of the Phase III CONTROL trial were presented at the
International Society for Thrombosis & Haemostasis in Boston this year (
http://bit.ly/5oBdS).  As many on the list will know this trial was stopped
for futility for the mortality endpoint.  As with the Phase II 2159 study
there was a trend to saving blood products but not outright mortality.

There was NO data presented at AAST to suggest that TEG/TEM can guide F7a
therapy (although we presented a poster on using ROTEM to diagnose Acute
Traumatic Coagulopathy).  Jeff Kashuk from Denver presented a small case
series of 35 patients describing their experience with TEG.  Nothing solid
about guiding transfusion therapy nor about F7a.

I don't think any more nails have been hammered into rF7a's coffin.  rF7a is
in the coffin already because of CONTROL and because of Novonordisk
withdrawing from the trauma arena.  Unfortunately CONTROL was poorly
designed because of lack of knowledge of the disease process and poor entry
criteria, so any signal was lost within the noise of a study that tried to
give a very high dose of F7a to a very large number of patients.

It would not surprise me that we're about to lose a useful drug because of
lack of knowledge of a disease process combined with the desperation of
trauma surgeons to adopt an unproven therapy and the regulator's insistence
on a mortality endpoint for trials of patients without capacity.  Hopefully
when we have more robust observational trials to characterise traumatic
coagulopathy we'll be able to design appropriate studies for future
procoagulants and other therapies.

Karim

2009/10/6 <KMATTOX at aol.com>

>
> In my view, the biggest thing to come out of the recent Amer Assoc Surgery
> of Trauma (AAST) meetings in Pittsburgh were TWO papers on analysis of
> studies  of rVIIa in real people and analyzing the past publications.
> Each
> could have been labeled , "The rise and fall of rVIIa.      The studies
> stated
> that basically there is no advantage of any kind that can be  discovered
> from either of these two well designed studies.  One was  performed by one
> of
> the most respected researchers in blood, blood products,  clotting, and
> resuscitation in the world.    He stated that the  entry criteria in the
> cases
> from the military were so poorly controlled, that no  good statement could
> be
> made about just what the entry criteria should be to  design a good study
> at this point in order to study this  product.     WOW.   No different from
> the early  Israeli studies of 13 years ago.       If there  was one
> observation that I could make is that maybe the TEG could have been a  good
> instrument to determine which cases just might benefit from rVIIa to be
>  given.
>
> k
>
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