From today's LA Times:
Lifesaving product of the war
Bandages that stop bleeding instantly may have saved the lives of soldiers wounded in Iraq. Now they're making their way to your home medicine chest.
By Melissa Healy, Times Staff Writer
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.
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."
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.
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.