BLOOD-CLOTTING DRUG Victory on the home front



The military uses QuikClot to stop blood loss, and this fall the drug will be introduced to households.
By MELISSA HEALY
LOS ANGELES TIMES
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.
From Iraq to home
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.
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.
Living with the risks
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.
Packaged for home use
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.
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 approaches
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.