1:1 Blood Resuscitation, Round 2.

[htaed_rd at 123mail.org]

On Wed, 20 Feb 2008 10:23:01 -0600, "McSwain, Norman E Jr."
<nmcswai at tulane.edu> said:
> Sorry but I do not  think that such a study can be designed and (at
> least in the US) get approved by an IRB. There are too many studies that
> already show benefit. 

So why doesn't everyone agree on this?

Apparently the research is not clear to all of those who interpret it
when making patient care decisions.

The result is that we essentially have a large scale uncontrolled
non-study of the random application of various treatments.

The patients do not benefit from the lack of convincing research.

As long as the science is not convincing the rest of the world, there is
a need for more and better research - even on topics you feel have
already been convincingly addressed.

What the IRB does not seem to consider is that only some of the patients
are receiving the best treatment now. As long as there are objections
that can be raised about the quality of the current research, there will
be those who will not follow the best practices. The only way to change
that is by a study that is so well done that the objections are
insignificant. Until that is done the behavior of the IRB, in my
opinion, is completely unethical in randomly denying patients access to
the best treatment. 

By not approving research this is exactly what the IRB is doing. Their
job is not to decide what needs to be studied, but whether the study
design is biased toward any treatment, whether the patients are
receiving essentially equal care with the exception of the variables
being studied. If the studies already out there have not convinced
everyone of the appropriate treatment, then the IRB needs to be
insisting that further studies do address the inadequacies of the
earlier studies. We do not need studies that will be ignored because the
new study contributes nothing to our understanding of patient care. We
have far to many of those already and there are plenty more of these
studies currently enrolling patients.

Even with an excellent large scale prospective study showing clearly
what leads to the best outcomes, there will be some who ignore this, but
they will be much fewer than currently and the care of the typical
patient will be much more consistent.

If the science is good enough, maybe what is needed is someone to
explain it to those who do not see the light.

Tim Noonan.


> Maybe not RPB studies but good retrospective
> studies. 3 were presented at AAST this year (as yet not in print) One
> done by my younger partner here at Tulane and Charity, Juan Duchesne. 4
> year retrospective review of trauma 2746 patients, 134 of which got >10
> units of PRC (626 pts got blood but < 10 units). Of the > 10 units with
> ratio close to 1:1 vs close to 1:4 mortality was 26% vs 87% (p:0.0001). 
> 
> We continue to use this process with permissive hypotension and very
> limited crystalloid. OR & post op hemorrhage is reduced, mortality is
> better, Puffy (Michelin Man) is much less, LOS is less. We COULD NOT get
> IRB to let us go back and not provide what (at least to us) is better
> care. 
> 
> Norman
>  
> Norman McSwain MD
> Professor, Tulane School of Medicine
> Trauma Director, Charity Hospital Trauma Center
> norman.mcswain at tulane.edu
> 504 988 5111