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Thu Oct 8 11:29:52 BST 2009

As a PI in study and as a frustrated trauma surgeon I agree with evey word you wrote.

----- Original Message -----
From: Karim Brohi <karimbrohi at gmail.com>
Date: Thursday, October 8, 2009 6:55
Subject: Re: AAST - rVIIa
To: "Trauma-List [TRAUMA.ORG]" <trauma-list at trauma.org>

> Ken
> I have to disagree with you.  The two papers presented were 
> registryanalyses.  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 
> insistenceon a mortality endpoint for trials of patients without 
> capacity.  Hopefully
> when we have more robust observational trials to characterise 
> traumaticcoagulopathy 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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> >
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> 

Gadi Shaked, MD
Department of Surgery
Trauma Unit
Soroka University Medical Center
Beer Sheva
Israel‎

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