Show Me The Science
Made from a specific type of potato starch, TraumaDEX contains particles that dehydrate blood and promote clotting through a gelling action.
All of the products currently under consideration in the Marine Corps’ studies have received FDA Pre-Market Approval, or their applications are pending. Those that are approved have already had some success on the commercial market treating various types of non-fatal lacerations and in the case of Biolife’s products, nosebleeds. Therefore, one should not interpret the Marine Corps study to say that of the three products tested, only QuikClot worked.
It should also be noted that the wounds created for the Marine Corps test were extreme and when left untreated, fatal. Further, both RDH and TraumaDEX have evidence of their success in non-fatal situations via letters from consumers and as the result of testing at local medical and veterinary facilities. This is both the good news and the bad news.
While anecdotal evidence and consumer missives are important, they don’t replace scientific research that supports manufacturers’ claims. The two Marine Corps animal studies admittedly do not constitute an overwhelming array of medical research, nor, in the eyes of some, do they provide significant statistical evidence of clinical effectiveness. They are, however, an important beginning. This is why, according to DaCorta, the rallying cry of police agencies that are considering adding a hemostatic product to officers’ patrol cars should be: “Show me the science.”
“With the exception of our research, there currently are very few objective, controlled studies in the medical literature,” DaCorta says. “Some of what the manufacturers tell you comes from hospital industry reports. Hemostatic products work well under those conditions, and there are lots of them approved specifically for that. But do they really work in a large wound? If a manufacturer claims it does, I’d ask to see their research.”
The problem is that there’s a dearth of literature on the subject. As mentioned earlier, prehospital care is not a hot medical research topic. Also, large drug companies do not want to risk investment dollars in hemostatic agents because the profit picture is not nearly as bright as it is for prescription drugs. In addition, since these products are derived from living or natural sources, they do not require the years of testing and clinical trials the FDA requires before granting approval to a new drug or class of drugs.
All of these factors conspire to leave law enforcement in the dark when it comes to proving a manufacturer’s claims. But the experts do have some advice on how to determine if these products will help your department save lives.
First, agencies considering a hemostatic product should make their search a cooperative one by including members of the local medical community, such as doctors, trauma room staff, paramedics, and EMTs. They should research the U.S. military’s experience and follow the progress of its current tests. They also should look at how foreign military handles battlefield injuries, especially those that are accustomed to fighting in hostile terrain. Most of all, the agency should ask the vendors lots of questions.
In the meantime, officers should brush up on their first-aid basics. “Know your ABCs,” DaCorta says. “We figure that about half of those who die from hemorrhage die from a hemorrhage that could have been controlled with a tourniquet or pressure dressing if someone had been there to do it. We have to realize that there is no silver bullet. Technology will never replace training. We just have to know our ABCs and stay calm.”
Manufacturers make a lot of claims about the efficacy of hemostatic products, but before you buy into the hype, make them answer these questions.
- Is the product safe? Effective? Better than the standard treatment now administered?
- Has it been tested on large, potentially fatal wounds?
- How was its toxicity tested?
- Are allergic reactions a possibility?
- Does the user need extensive training?
- If the manufacturer claims the product stops bleeding, does it provide comparisons to standard treatment and to similar products?
- Can the officer open it with one hand?
- Can the officer use it in the rain? In the dark?
- Are the instructions clear?
- What is the shelf life of the product? What kind of storage does it require?
- If the product has been independently tested, who paid for the testing? Were other products included in the test or was the product compared to a standard form of treatment?
- Has the product been field tested? By whom?
- Will the company provide references and contact information for previous buyers of its product?
- What is the company's FDA 510(K) status? Ask the company for copies of its safety and efficacy studies.
- Does the FDA have any negative reports about the product?
A New Kind of War
In the post-Cold War era, the nature of warfare is rapidly changing with terrorist activities, ethnic/tribal conflicts, and organized criminal violence replacing the traditional combat between well-organized armies. The future conflicts are likely to be in urban areas (Somalia) or in hostile terrain (Afghanistan) between an ill-defined enemy and small rapidly mobile U.S. combat units.
In Mogadishu, Somalia, during a 15-hour urban battle, 18 U.S. soldiers were killed and more than 100 injured. Some of these soldiers had been pinned down by sniper fire in the battlefield for more than 14 hours before they could be evacuated.
The injury patterns are also evolving. Due to the urban nature of conflict, and the use of body armor and Kevlar helmets by U.S. soldiers, the nature of injuries in Somalia was noticeably different compared to previous conflicts (Vietnam). There was a marked decrease in fatal torso injuries while penetrating wounds to the face, groin, and pelvis caused significant mortality.
Early combat casualty data from the war in Afghanistan is showing similar trends. For example, during Operation Anaconda (Shahikot Valley) on March 4, 2002, over the course of 17 hours, seven American soldiers were killed in action. Enemy fire caused major delays in evacuation, and, as a result, one soldier died from a bleeding groin/pelvic wound almost seven hours after being injured (two hours before the first of three evacuations).
As seen in these conflicts, the logistic support has been limited near the frontlines and delays in evacuation are common. Early and effective hemorrhage control is even more important in these situations and could save more lives than any other measure. [Source: "Use of Hemostatic Agents in Complex Extremity Injury," primary author Hasan B. Alam, M.D., Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, Md.]
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Lois Pilant is the former editor of a law enforcement magazine, a writer for the National Institute of Justice, and a frequent contributor to POLICE.