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Z-Medica's Products Cited as Life Saving on the Battlefield
Hemorrhage Control Uncontrolled hemorrhage is the leading cause of preventable combat deaths. A vast majority of these deaths occur in the field before the injured can be transported to a treatment facility. Early control of hemorrhage remains the most effective strategy for treating combat casualties.
 Jan 24, 2008 -- By Patrick E. Clarke Unquestionably hemorrhage is the leading cause of preventable combat deaths. The vast majority of these deaths occur in the field before the injured can be transported to a treatment facility. Early control of hemorrhage remains the most effective strategy for treating combat casualties. Effective hemostasis—or arrest of bleeding (as by a hemostatic agent)—is the goal. Richard M. McCarron, Ph.D., who heads the Trauma & Resuscitative Medicine Department at the Naval Medical Research Center (NMRC) in Silver Spring, Md., offers several sobering statistics that highlight why the area of hemorrhage control dressings and treatment is such a high priority for both the military and the civilian medical community: In the civilian population, about 30 to 40 percent of trauma deaths are due to uncontrolled bleeding. In Iraq, according to a Marine Corps Trauma Registry, 45 to 60 percent of combat casualty deaths are due to potentially preventable uncontrolled bleeding. Human testing simulating a lethal wound and/or a high pressure bleed is not required for this research, so pigs are used. Two animal models are used for testing, in Dr. McCarron’s lab. In the first method, the pig is given a complete transection of the femoral artery and vein in the groin area, which leads to uncontrolled hemorrhage. “That sort of wound isn’t easily compressible, so a large amount of blood is lost in a short period of time,” said McCarron. The vessel cut is made, then the researchers wait two to three minutes to simulate the delay in the arrival of a corpsman on a battlefield—then the bandage is applied. “The bandage is evaluated on its ability to stop blood loss and increase survival of the animal,” said McCarron. In the second method, “We poke a hole in the blood vessel—which results in severe arterial bleeding [high pressure and pulsatile],” said McCarron. “Not as much blood is lost, but it does result in a high pressure wound.” And corpsmen do have to cope with high pressure wounds in Iraq and Afghanistan. Researchers from the U.S. Army Institute for Surgical Research and the Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, Md., listed seven criteria for the ideal hemostatic dressing for prehospital use: It should be able to stop large-vessel arterial and venous bleeding within two minutes of application on the wound, even when applied to an actively bleeding site through a pool of blood (a likely field scenario). It should be ready to use, with no requirement for mixing or special preparation. It should be simple to apply by the wounded individual, his buddy, or a medic/emergency medical technician with minimal training required. It should be lightweight and durable. It should be stable and functional at room temperature for at least two years and in extreme ambient temperatures (-10 degrees C and 55 degrees C) for several weeks or longer. It should be safe to use, posing no risk of either injury in the tissue to which it is applied or of bacterial or viral transmission. It should be inexpensive. McCarron adds that, “It should allow for easy removal once the patient is back at a support hospital.” Re-bleeding is another key concern, according to McCarron. “As the patient’s blood pressure goes up, it can cause the clot to push out and the wound will start bleeding again.” Wallingford, Conn.-based Z-Medica Corporation has a hemostatic agent that meets enough of the desired criteria to be standard issue for the Marines and the Air Force. The product is called QuikClot. “QuikClot is incredibly effective at stopping bleeding,” said Ray Huey, CEO of Z-Medica. “If you’re able to get QuikClot at the source of the wound it will stop bleeding.” The company is already on their third generation of QuikClot, known as QuikClot ACS+. “The original QuikClot was effective and affordable, but it could generate a lot of heat,” explained Huey. “In about 2 percent of the cases the heat from QuikClot led to second degree burns.” Also, the original QuikClot was powder, which led to some problems applying the product in the field. “If it was applied while the patient was being transported in a helicopter—the powder could blow away,” noted McCarron. “With QuikClot ACS+ the agent is in a sponge format, which gives the user the ability to apply it to a pumping wound more effectively,” said Huey. He emphasized that, “There is no more risk of burn.” “We also changed the product from granules to a BB-like substance that is in very porous surgical gauze.” Z-Medica does provide training in the use of QuikClot ACS+. “After all, the product is meant to be used in a very stressful environment,” said Huey. The company has Web training videos and a number of train the trainer courses. The company has also developed a new product known as Z Hemostatic Gauze. “It’s easier to use on a penetrating wound because it’s easier to pack it in, said Huey. “Again, if you get it in contact with the source of bleeding, it’s phenomenally effective.” The HemCon Bandage, manufactured by Portland, Ore.-based HemCon Medical Technologies Inc., is the hemostatic agent of choice for the U.S. Army. Every soldier deployed in Iraq and Afghanistan carries a HemCon bandage in his IFAK (individual first aid kit), in addition to being carried by all Army medics, according to Staci McAdams, vice-president of marketing for HemCon. “HemCon Bandages are manufactured from a natural product called chitosan, a substance found in the shells of shrimp, crab and other crustaceans,” according to McAdams. “The HemCon Bandage controls bleeding by becoming extremely sticky when in contact with blood. This adhesive-like action seals the wound and allows injured soldiers to reach critical care,” said McAdams. She continued, “The HemCon Bandage also forms an antibacterial barrier that may help prevent infection.” The bandage is small and lightweight, which makes it easily portable. The Army even named the HemCon Bandage as one of the 2004 “Top Greatest Inventions.” The awards, given annually by the U.S. Army Research, Development and Engineering Command, recognize the best new technology solutions impacting soldiers on the battlefield. HemCon has developed training videos that demonstrate the proper application and removal of all of their products. “The videos can be easily downloaded from our Website,” said McAdams. TraumaCure Inc., based in Bethesda, Md, has developed what it calls a groundbreaking product to stop high-pressure arterial bleeding. Known as WoundStat, the product will be available in December. Referring to the animal testing models described earlier, “WoundStat works 100 percent of the time,” said Devinder S. Bawa, CEO of TraumaCure. “No two ballistic injuries are the same,” said Bawa. The odds are that a ballistic wound will be irregularly-shaped. “We feel that the ideal product has to conform to the irregular shape of the ballistic injury,’’ said Bawa. He continued, “WoundStat, being granular, pours easily and conforms to the irregular shapes of serious wounds.” WoundStat comes in a 5 ½ inch pouch that the medic can rip open with one hand and pour into the wound, according to Bawa. WoundStat won’t blow away because it is a heavy gauge grain, and it’s completely safe to use. “The primary compound is on the Food and Drug Administrations’ Generally Regarded as Safe [GRAS] list.” said Bawa. The idea is to press WoundStat and mold it into the wound cavity. “In internal tests we achieved hemostatis—where the bleeding stops—in 60 seconds,” said Bawa. And if a warfighter starts to re-bleed, “Instead of tearing out the dressing, the medic can remold the WoundStat dressing, and that’s often sufficient,” said Bawa. “Or, the medic could add a little more WoundStat.” Cambridge, Mass.-based Aurora Flight Sciences Corporation is in phase two of a Department of Defense Small Business Innovative Research (SBIR) funded project to develop a swelling hemostat, according to Dr. Liping Sun, a senior scientist with Aurora’s Payload Systems Division. “Aurora’s swelling hemostat uses a polyacrylic acid-based super absorbent polymer powder to absorb the aqueous [water-based] components of blood and expand, with a total absorption of 30 times its initial weight, within two minutes,” said Sun. “After absorption, the polymer holds the blood even when compressed.” Sun explained that Aurora’ swelling hemostat controls hemorrhaging of compressible and non-compressible extremity injuries through three distinct mechanisms: 1. Swelling by absorption of the aqueous components of the blood present in the wound and independently exerting sufficient pressure to maintain contact with the bleeding site 2. Dehydration of the blood in the wound during absorption that accelerates the clotting cascade 3. Mechanical fluid blocking effect achieved by the swelling polymer “The combination of physiological and mechanical actions makes it functionally unique and increases the probability of successful hemorrhage control even with coagulopathic [when the person’s blood has difficulty coagulating] victims,” said Sun. The device has been tested in 20 pigs using two proven models of fatal groin injury, including complete transaction and partial transaction of the femoral vessels, according to Sun. “The device has achieved a survival rate of 100 percent vs. 40 percent for the control model, with an 80 percent comparative reduction in post-treatment fluid loss,” said Sun. “In these experiments, the control group was treated with a standard U.S. Army issue gauze roll.” Phase three of an SBIR project involves the company commercializing the product in military and/or private sector markets using non-SBIR funds. “In the future, we will continue the development of the hemostatic device to address a wider range of applications for battlefield hemorrhage control to include other types of non-compressible injuries,” said Sun. The NMRC is also doing research on the treatment of intra-abdominal hemorrhage due to blunt force trauma or a penetrating missile injury. “Hemorrhage in that area is extremely difficult to treat,” said McCarron. “Say a person’s liver is damaged—you can’t apply a bandage.” He continued, “We’re investigating the use of infusible hemostatic agents, derived from human platelets.” The platelets would migrate to the wound site, explained McCarron. “The idea is to be able to inject a drug and to be able to stop the internal bleeding in the field until the casualty is evacuated and surgeons can repair the injury in the hospital.” McCarron thinks there have been tremendous advancements regarding hemorrhage control dressings and treatments. “The capacity to stop bleeding [and re-bleeding] as well as delivery of hemostatic agents to specific sites are areas that will continue to evolve leading to improved applications.”