WoundStat,

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The information that I have seen indicates that this decision was made based on one study involving only 21 animals, using a single model of an open carotid artery. There was no long term outcome. I think the study is important but NOT enough for an recall of the entire material. Nor for us to not use it on the type of injures that  most of our EMS services are faced with. Other products with adverse outcomes have been left in the field. The response does not seem to be based on enough data. Perhaps I have not seen all of the data.
 
I strongly believe in hemostatic agents when: 1) pressure dressings do not work, 2) the injures are on the torso and 3) a tourniquet cannot be applied. This is a generic statement and not specific for any one product. However, I have not seen much use in the civilian community when the patient is not in danger, such as the middle of combat, and the hospital care is just a few minutes away. Very seldom does properly applied pressure dressing not give adequate hemorrhage control to get the patient to a hospital. This need not be a trauma center but one where a hemostat (or several of them) can be applied to the bleeding vessel. 
 
Intra-abdominal hemorrhage is different and not part of this discussion. We are discussing not cavity hemorrhage
 
Norman
 
Norman McSwain MD
Trauma Director, Charity Hospital
Professor of Surgery, Tulane University
New Orleans LA
504 988 5111
norman.mcswain at tulane.edu <mailto:norman.mcswain at tulane.edu> 

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From: trauma-list-bounces at trauma.org on behalf of listasmsd
Sent: Thu 1/1/2009 8:14 AM
To: Trauma &amp; Critical Care mailing list
Subject: WoundStat,



WASHINGTON (AP) - Until more testing can be done, Army medics are
being told to stop using a new product just sent to the war front to
help control bleeding among wounded troops.

Officials were in the process of distributing some 17,000 packets of
WoundStat, granules that are poured into wounds when special bandages,
tourniquets or other efforts won't work. But a recent study showed
that, if used directly on injured blood vessels, the granules may lead
to harmful blood clots, officials said Tuesday.

The Army Medical Command will continue its research and work with the
manufacturer in hopes of figuring out in the next few months whether
to resume use of WoundStat, said Col. Paul Cordts, head of Army health
policy and services.

WoundStat manufacturer TraumaCure Inc. of Bethesda, Md., said late
Tuesday that "experts differ" on whether the Army's most recent
testing, which put the granules into surgically-created injuries in
swine, is relevant to a product used in a trauma setting. But the
company said it would cooperate with the military on research to clear
up any questions.

"It is important to note that there have been no reported incidents or
adverse outcomes in humans" from the product, Jack McDonnell, chairman
and CEO of TraumaCure, said in a statement. "WoundStat has been used
in the field and in U.S. hospitals where it has saved lives by
stopping traumatic bleeding in accidents, gunshot wounds and major
surgical bleeding."

The product had been approved by the Food and Drug Administration. It
was one of the latest in a series of Army efforts to improve survival
rates on the battlefield.

Today, 90% of injured troops survive their wounds, the highest rate of
any war, Cordts said in an interview. He credited better training of
combat medics, better body armor the troops wear and better tactics
they use on the battlefield, as well improved bandages, tourniquets
and so on.

Defense Department figures show that as of this month, more than 4,800
troops have been killed in Iraq and the global war on terror. The
latter category counts casualties mostly from Afghanistan. Some 34,000
troops have been wounded in the wars, where insurgents have made wide
use of roadside bombs and other explosives.

Excessive blood loss is the number one killer on the battlefield, and
the Army announced in October that it was sending two potential
lifesavers - the WoundStat packets and a bandage called Combat Gauze -
to replace older other products that had been in use at the time.

A committee of Army medics, Navy corpsmen, surgeons and others
recommended the Combat Gauze bandage - which has an agent that
triggers blood clotting - should be the first-line treatment for
life-threatening hemorrhaging in cases where a tourniquet could not be
placed, such as the armpit or groin area.

The WoundStat granules were to be used if the bandage failed to work.

Cordts said the Army put out a message on Dec. 18, directing the
temporary halt in use of WoundStat. Though it has arrived at the war
zones, officials are unclear on how widely it has been distributed so
far. They're working to identify any soldiers who got the treatment,
study their cases and examine them for any problems with blood
clotting, Cordts said.

He said he didn't know whether it had been used on any soldiers and
thus had no reports back from the field - positive or negative - on
how effective it might have been.

Cordts said that after an additional few months of study, officials
will likely determine whether they should discontinue its use
altogether or perhaps redistribute it with warnings for how it is to
be used.
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