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1:1 Blood Resuscitation, Round 2.

Ronald Gross Rgross at harthosp.org
Wed Feb 20 17:12:06 GMT 2008


Norm,
That is exactly what I was driving at when I threw in the "BUT" - the fact is that we know it is better then what we have been doing, and so to subject someone to the other treatment arm would be unethical.  Simple, really.
Take care,
Ron

>>> "McSwain, Norman E Jr." <nmcswai at tulane.edu> 2/20/2008 11:23 AM >>>
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. 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
-----Original Message-----
From: trauma-list-bounces at trauma.org 
[mailto:trauma-list-bounces at trauma.org] On Behalf Of Ronald Gross
Sent: Wednesday, February 20, 2008 6:52 AM
To: Critical Care mailing list Trauma &amp
Subject: Re: 1:1 Blood Resuscitation, Round 2.

OK then - I guess I believe in fairy tales - and the expert opinion of
folks like Holcomb and Spinella, the guys that have done this and have
shown the efficacy of the 1:1 transfusion protocol.  Their proof?
Simple - kids that, by the data and by the numbers should have gone home
in a box....but came home on a stretcher.  Add to that a half dozen of
my own patients now that I am back home that have also defied the odds.

I agree with Ken - putting together a large scale prospective and
randomized study is a must.  The big BUT here is that knowing even the
little that we do know, can you ethically justify jeopardizing the lives
of those that will receive our "conventional" resuscitation, which, by
the way, some also would challenge as fairy tales...

Just my uninformed 2 cents.

Ron

>>> Sanjay Gupta MD <sanjaygupta99_91 at yahoo.com> 2/19/2008 5:25 PM >>>
No offence meant to anyone, but there is certainly no
evidence of efficacy of 1:1:1 transfusion, although,
it seemed to have worked in a few patients that I have
treated with that approach.  My two thoughts about
this practice:


1. How do you design a study that randomizes different
blood transfusion protocols? - possible, but difficult
to carry out in large enough numbers.  Also, because
no drug is involved, there will probably be no
corporate sponsor with deep enough pockets to carry
out this study.  If you randomize one protocol with
Factor VII transfusion - that might get some
financing, but I could almost predict the result of
that study, if such a study does get going.



2. Expert opinion is level 4 (or level 5 - I forget
which) evidence - just one level away from
fairy-tales.


Sanjay




--- Ronald Gross <Rgross at harthosp.org> wrote:

> Gotcha.  On that I do agree.
> 
> Take care,
> Ron
> 
> >>> <htaed_rd at 123mail.org> 2/14/2008 1:44 PM >>>
> On Thu, 14 Feb 2008 12:08:35 -0500, "Ronald Gross"
> <Rgross at harthosp.org>
> said:
> > Tim,
> > 
> > Sorry to ask, but what exactly is/was your point?
> 
> If Dr. Mattox was not just being polite when he
> wrote "YES, I agree.  
> It will be a great session, and I don't really  know
> who will
> will win.   It will all be in the  delivery," then
> the research
> certainly needs to improve significantly. We have
> far too much that is
> the result of persuasive researchers. In stead, we
> need persuasive
> research, not charismatic people driving patient
> care decisions with
> research that does not address what it claims to
> address. I am not
> stating that there is any particular trauma study
> that this would
> describe, but that if the delivery is the deciding
> factor, the research
> is less than adequate.
> 
> Tim Noonan. 
> 
> 
> > Ron
> > 
> > >>> <htaed_rd at 123mail.org> 2/14/2008 10:27 AM >>>
> > We need to do research that will be large enough
> to produce enough
> > subjects in the various treatment arms that
> differences in outcome will
> > be clear.
> > 
> > As long as the research is small enough, or not
> well enough controlled,
> > that readers can look at the study and state that
> it is flawed, we will
> > be avoiding progress.
> > 
> > In 1989 in the cardiology community the question
> was which
> > antiarrhythmic, when given to patients who had had
> heart attacks, would
> > save the most lives (and make drug companies the
> most money).
> > 
> > All of the studies prior to that point had been on
> a surrogate end point
> > - which drug did a better job of eliminating PVCs.
> > 
> > It was taken for granted that, since patients with
> PVCs die more
> > frequently than those without PVCs, that
> eliminating PVCs saves lives.
> > 
> > The experts were in agreement on this theory.
> > 
> > The study was large enough to show survival
> differences and it was
> > allowed to go long enough to produce statistically
> significant numbers.
> > 
> > Too many studies are stopped early because the
> results are "too good to
> > justify withholding the study treatment from
> others," or vice versa.
> > 
> > How many of these treatments are found to be as
> beneficial/harmful in
> > follow up research?
> > 
> > How much of this is self delusion by the study
> designers?
> > 
> > The result of the CAST (Cardiac Arrhythmia
> Suppression Trial) was a
> > surprise to the cardiology world.
> > 
> > One of the drugs was leading to study participant
> deaths at 3 to 4 times
> > the rate of placebo.
> > 
> > The best that could be said about any of the drugs
> was that it did not
> > appear to be killing the patients at a greater
> rate than placebo.
> > 
> > All of these drugs are still used, just not very
> often.
> > 
> > Cardiologists no longer prescribe drugs to get rid
> of PVCs to everyone
> > who has had a heart attack.
> > 
> > Antiarrhythmia therapy has become much more
> conservative (part of that
> > is due to implantable defibrillators).
> > 
> > Had this study not been done, how long might it
> have taken before
> > someone realized this treatment was harmful.
> > 
> > Almost 20 years later, would this still be the
> focus of care following a
> > heart attack?
> > 
> > Diseased hearts have PVCs due to underlying
> disease.
> > 
> > Giving the patient a rhythm stabilizing drug does
> not change the disease
> > process, at least not for the better.
> > 
> > This study should have been an example to
> researchers everywhere.
> > 
> > In stead, it is viewed as an oddity specific to
> the cardiology
> > community.
> > 
> > It is not.
> > 
> > We need research that does an excellent job of
> controlling for as many
> > variables as possible.
> > 
> > Too much research contains discussions of why
> variable A is not worth
> > controlling for, even though it would have been
> relatively easy to
> > control for it.
> > 
> > We need to keep these flawed researchers from
> continuing to do fatally
> > flawed research.
> > 
> > How is it that experienced researchers, with
> doctorates in their fields,
> > continue to engage in research that should not
> receive passing marks
> > from a high school science teacher? 
> > 
> > The scientific method is one of the most important
> tools we have.
> > 
> > Its misuse kills.
> > 
> > Tim Noonan.
> > 
> > 
> > On Thu, 14 Feb 2008 06:03:48 -0800, "Sise, Mike
> MD"
> > <Sise.Mike at scrippshealth.org> said:
> > > So there is controversy over 1:1. How do we
> answer the question? Is a
> > > randomized trial justified or is it promising
> enough to just do it? On
> > > the one hand, we spent over 40 years using the
> intellectually attractive
> > > "balanced salt solution" lactated ringers
> without examining its impact.
> > > And blood transfusion therapy during the same
> interval may have been
> > > dictated by the technology that allowed
> fractionated blood banking - we
> > > abandoned whole blood. On the other hand, the
> results of 1:1 appear
> > > extremely promising. Pre-treatment Informed
> consent will be out of the
> > > question. Soooo, how about it Ken, Karim, Ron,
> Tim, all you
> > > trauma.org-istas.
> > >  
> > > Mike Sise
> > > San Diego
> > > 
> > > "Scripps Information Security" 
> > >
>
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Sanjay Gupta
Tel: 412 335 6304


 
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