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WASHINGTON
One of the Iraq war's most dramatic lifesaving technologies
is expected to make its civilian debut this fall, when it
becomes available for household use, according to the company
that makes it.
QuikClot
is a granular powder, a refined mineral called zeolite that
looks like cat litter and has many industrial uses. But when
poured onto a grievous, bleeding wound, QuikClot staunches
blood loss almost instantaneously. It is one of a group of
new "hemostatic agents" that are on the market or in development.
Two of them were sent into battle. The small bag of clotting
agent was carried in every Marine rucksack and appeared to
spell the difference between life and death for 19 soldiers
wounded in Iraq, according to Defense Department medical officials,
who helped speed Food and Drug Administration clearance for
QuikClot in May 2002. In the process, the new product -- along
with other innovations in military trauma care -- significantly
boosted survival rates among those wounded in the Iraq war.
In
one case, a Marine was shot through the neck. The bullet nicked
his carotid artery before exiting from the back of his skull.
As the Marine bled profusely, QuikClot was poured onto his
wound, sealing it immediately. He made it alive to a field
hospital and later to a Navy hospital ship -- a casualty that
probably would have been a fatality in the Persian Gulf war.
Now,
however, Z-Medica, the small Connecticut company that makes
QuikClot, has its eye on saving those wounded in civilian
life: in automobile wrecks, shootouts, airline disasters and
household accidents. Late this summer, the company said, it
expects to begin selling QuikClot through U.S. retail stores
with no prescription required. Its sales pitch: Having the
product handy could help a person with no medical or emergency
training stop the massive bleeding that causes some 50,000
deaths a year, mostly the result of traffic accidents.
The
military-issue "trauma pack" carries a price tag of about
$22; the smaller version for household use will sell for less
than $10.
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Enhancing self-reliance
At
a time when terrorist attacks have blurred the line between
combatants and bystanders, experts say the growing number
and availability of hemostatic agents such as QuikClot and
HemCon -- another military clotting product that draws blood
into tiny vessels and effectively plugs a gaping wound --
could make almost anyone with a well-equipped first aid kit
an emergency first responder.
"Issues
of self-reliance have become very important in the context
of homeland defense," said Bart Gullong, executive vice president
of Z-Medica, which makes and markets QuikClot, its sole product.
In disasters and public health emergencies, Americans want
to be able to help themselves and their families, he said,
and the company's plans fit in with that.
But
these wonder products are not without risks. Because of the
speed with which it draws water into itself, QuikClot can
generate enough heat to burn tissue if too much is used.
According
to a study to be published next month in the Journal of Trauma,
researchers with the Uniformed Armed Services Health Services
found that, compared with two other clot-boosting bandages
and traditional wound dressing, QuikClot performed best overall.
But the product HemCon, which the Army favors, is believed
to stem blood loss better in certain smaller injuries. It
may have to be removed more quickly than other hemostatic
bandages, however, and is several times more expensive than
QuikClot.
Fibrin,
another clotting agent under joint development by the Army
and the American Red Cross, is derived from human blood and
could cost $2,000 per application.
"I
don't like it, but when you ask me one of the best ways to
stop bleeding, it's QuikClot," said Dr. Peter Rhee, a trauma
surgeon at Los Angeles County-USC Medical Center, who has
used the newest hemostatic agent extensively in the last year.
"It
does stop bleeding, and it does save lives. In trained hands,
it does work well," said Rhee, who also directs the Navy's
Trauma Training Center at County-USC.
Rhee
is concerned that QuikClot could be risky if used by consumers
with a poor knowledge of the product and of traumatic injury.
He has higher hopes for other coagulant bandages making their
way onto the market.
Dr.
Hasan Alam, a trauma surgeon at Washington (D.C.) Hospital
Center who participated in the testing of QuikClot, said the
product should be put in a form different from the 3.5-ounce
packets provided to Marines.
"If
you start selling it in Wal-Mart, you have to come up with
a strategy to prevent its misuse," Alam said. Given the risks
of burns, pouring the substance onto skinned knees and shaving
cuts is "like using a sledgehammer to kill a fly."
Z-Medica
is exploring whether QuikClot may someday be used to stem
bleeding in surgery (an internal use that probably would require
extensive additional testing for FDA approval), or for the
management of unusual bleeding among hemophiliacs, diabetics
and those taking blood thinning medication, company executives
say.
Rhee
provided a dramatic preview of QuikClot's possibilities in
emergency surgery at County-USC last winter. A patient with
multiple gunshot wounds to the chest was bleeding everywhere.
In spite of frantic efforts, the bleeding continued unchecked.
With
the man's life ebbing away, a colleague urged Rhee to try
using QuikClot internally -- an "off-label," or unapproved,
use considered acceptable in cases when no viable alternative
is available to save a patient. He did, and the bleeding stopped.
"It
was absolutely the last thing" available, Rhee said. "I had
actually made my decision to let him die This guy walked out
of the hospital a week later."
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A longer 'golden hour'
On
the battlefield as well as closer to home, uncontrolled bleeding
kills many in the first hour following an injury. For others,
massive blood loss can cause shock, which can cause complications
and death later, even for patients who make it quickly to
a hospital.
When
emergency medical technicians, fire and police units and even
ordinary citizens can apply dressings that staunch bleeding
well before a victim arrives at the hospital, doctors such
as Terry Soldo, a Navy "Devil Doc" who served in Iraq and
saw QuikClot used twice, are certain that more lives can be
saved.
"They
talk about the 'golden hour' " in which EMTs and doctors can
keep a bleeding injury victim from dying, Soldo said. "If
you could control hemorrhage earlier, the 'golden hour' can
last longer. If they can control that, in my opinion, it would
make a huge difference."
Francis
X. Hursey, who developed QuikClot, discovered the properties
of zeolite, a granular volcanic material, when he was developing
gas-separation and -purification equipment for medical and
industrial uses. One day more than a decade ago, he sliced
himself shaving and decided to apply a bit of the water-absorbing
zeolite to the cut.
By
sucking up the water from the exposed blood, the material
concentrated the blood's remaining coagulants. To Hursey's
astonishment, his shaving nick sealed itself in seconds.
Other
"hemostatins" seek to achieve the same effect with different
materials and in different ways. Although some add coagulants
at the wound site, others constrict bleeding arteries near
the wound and activate platelets to speed healing.
QuikClot
and Emergency Medical Products' TraumaDex, one of the early
entrants into this field, work on the "aquasponge" principle.
HemCon and Marine Polymer Technologies' RDH bandage effectively
plug a wound. All but QuikClot are made of a sugar-related
substance called chitosan that comes from shrimp shells, seaweed
and algae.
Doctors
say each has an area of strength. The RDH bandage, for instance,
has shown particular promise for in stemming bleeding from
liver lacerations but may be less effective in larger, gaping
wounds. The TraumaDex bandage is absorbed by the body; unlike
HemCon and QuikClot, it doesn't have to be removed by a doctor
before repairs can be made.
QuikClot
currently is distributed to police departments, fire and rescue
squads, and hikers and hunters who venture far from emergency
health care. Starting in September, Z-Medica plans to sell
it over the counter in pharmacies, convenience stores and
supermarkets.
Z-Medica
executives believe that in addition to its still-preliminary
record of effectiveness on the battlefield, their product
has two things in its favor for consumer use: low price and
ease of use. The packet , which was carried into combat by
more than 50,000 U.S. troops, can be applied by the wounded
soldier himself -- if necessary, held in one hand and torn
open with the mouth. Pressure must be applied to the wound
before and after the application. During the Iraq conflict,
the QuikClot packets were so coveted by British soldiers that
they offered to trade bottles of Scotch and war trophies to
secure them from American GIs.
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Battlefield lives
HemCon
Inc., a Portland, Ore., company that received FDA approval
for its bandages in November 2002, is working on new versions
for the Army and for testing by the Marines, said Dr. William
Weismann, the company's founder.
Military
planners long have recognized that slowing blood loss on the
battlefield and during evacuation is their best chance of
reducing fatalities. Shortening the time to a field hospital
can help, and U.S. forces accomplished that in Iraq by dispatching
medical teams and rapidly movable treatment facilities to
areas closer than ever to the front lines. But if blood loss
also could be stemmed, according to Pentagon estimates, 1
in 5 men and women who might otherwise die in war could go
home to their families.
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