Dave Sanders bled to death. Shot twice in the shoulder, the 47-year-old teacher managed to shepherd students from the library at Columbine High School to safety during the 1999 massacre launched by Dylan Klebold and Eric Harris. Shot minutes into the assault, he rushed students into a science classroom where they, in turn, desperately tried to save his life. But when help finally came four hours later, Sanders was dead. Minutes before his death, students took pictures of Sanders’ three children out of his wallet so he could see them one last time.
Experts—-law enforcement, medical, and legal-—still disagree on whether getting to Sanders sooner would have saved his life. Sanders’ family sued and later settled the case against Colorado’s Jefferson County Sheriff’s Department. The JCSD admitted no wrongdoing in the case. However, it did change its policies regarding how it would handle future incidents.
But Sanders didn’t need a policy change or revised operational procedures. What he needed was something to stop the bleeding. His death is illustrative of a fact that medical and military personnel have known for years: 90 percent of people who die in war die before they reach a medical facility. Fifty percent of combat casualties die from bleeding, and most of them die less than 30 minutes after injury.
“Of that, 50 percent to 60 percent die in the first five minutes,” says Lt. Cmdr. Joseph DaCorta, a former Navy field medic who is now a project officer at the U.S. Marine Corps Warfighting Lab in Quantico, Va. “The remaining 30 to 40 percent die from five minutes to 60 minutes. A lot of these are wounds to the extremities, where the vein just lays there and oozes blood. There is not a lot we can do in the belly or with a head wound, but for someone to die of an extremity wound these days is just a tragedy because about half of them could have been controlled. That’s a quarter of the combat deaths that we should be able to do something about.”
The statistics for trauma on the streets of the United States are not much different. If a person can be taken to a Level 1 medical facility or trauma center within minutes of his or her injury, there is a 97 percent chance of survival. It is astonishing that medical science, advanced as it often appears, has yet to address the reasons why people die so quickly before they reach a hospital.
As many medical experts will attest, little is known about prehospital care, which is apparently the redheaded stepchild of medical research. Billions of dollars have been spent on studies and the collection of statistics that detail what happens after patients reach the hospital. Little has been spent on studying what happens before they get there.
One of the results of this neglect of pre-hospital trauma care is that on the streets or on the battlefield, a person has the same chance of bleeding to death today as did a soldier in the Civil War.
Biologics and Devices
Hemostasis, or the ability to stop bleeding, has been called the most significant public health challenge in the 21st century. This is especially true given that motor vehicle injuries cause 1.5 million deaths a year, and that many of these could be prevented if there were a way to staunch a fatal hemorrhage.
Since police officers are routinely the first to arrive on the scene of a car wreck or a gun battle, they need something more effective than a tourniquet or a pressure bandage. And several companies are now competing for that business with hemostats that they claim will stop bleeding in seconds.
Each hemostatic product is remarkably different from its competitors. One has a mineral base, another is derived from algae, another from lava rock, and yet another from the thrombin in cow’s blood. One is granular, one is a powder, another looks like a bandage. All are supposed to work in seconds. But the question is, do they really work? And it’s not easily answered because unlike synthetic drugs that require years of FDA testing prior to approval, the manufacturers of biologics like hemostatic agents don’t have to do extensive research to back up their claims.
Tell it to the Marines
For obvious reasons, the Marines have taken great interest in researching the efficacy of hemostatic products. In 2000 the Marine Corps Warfighting Lab undertook a study funded by the Office of Naval Research. The goal was to find a product that worked on the battlefield. The following three products were tested:
Rapid Deployment Hemostat Bandage (RDH) is made by Marine Polymer Technologies in Danvers, Mass., and derived from single-cell algae found in the ocean. For the test, Marine Polymer supplied a 3.5-inch poly-N-acetylglucosamine disk backed by a 4-inch by 4-inch square of gauze. According to the company, the RDH bandage placed on a wound will attract plateaccelerate clotting.
QuikClot, from Z-Medica in Newington, Conn., looks like cat litter, and is a granular zeolite derived from lava rock that absorbs water. When poured into a wound, it absorbs the water molecules in the blood, creating a high platelet concentration to facilitate clotting. It also produces heat, through an exothermic reaction, if the product comes in contact with water. Because of this, the user is instructed to remove all water from the wound area prior to use. The material can later be removed by aspiration or irrigation.
TraumaDEX, manufactured by Minneapolis-based Medafor Inc., is a plant-based material that consists of bioinert microporous particles that dehydrate the blood. TraumaDEX is made from a specific type of potato starch and comes in powder form, and when applied to a wound it promotes clotting by producing a gelling action. It does not have to be removed later because, according to the company, it is absorbed by the body within hours.
The Marine Corps study involved tests on six groups of animals (three control and three experimental). One group received no treatment at all for a complex extremity wound; a second group received the standard treatment of a gauze bandage and pressure to the wound; a third experimental group received standard treatment and aggressive resuscitation with fluids; the fourth group received standard treatment and limited resuscitation (which is the standard type of medical response in this country). The remaining two groups received treatment with the various hemostatic products.
When the RDH was used, the survival rate was 33 percent. When TraumaDEX was used, the survival rate was 67 percent, which duplicated the results from the group that received the standard treatment of pressure and a dressing. When QuikClot was applied to the wound, the survival rate was 100 percent, with a significant reduction in blood loss. According to the study, “The RDH bandage and TraumaDEX, which have shown promising results in less severe models, failed to offer any advantage in our study. QuikClot, a relatively unknown agent, proved to be remarkably effective and significantly improved the short-term outcome.”
The Lab currently is conducting a follow-up test, comparing a reformulated version of QuikClot that does not produce an exothermic reaction; an increased dosage of TraumaDEX from the 10 grams used in the first test to 30 grams; the HemCon Bandage, which is a shrimp-based product that uses chitosan as its active ingredient; Urgent QR, manufactured by Biolife, which is composed of a non-toxic mixture of a hydrophilic polymer and a potassium salt; and a form of bovine thrombin-based material, which has been used for many years to stop bleeding in surgical procedures.
“We started doing these studies because the Marine Corps wanted to re-engineer its individual first-aid kits and the question was, ‘Is there a good hemostatic product out there?’ This is an item we’re going to put in an unskilled, non-medical person’s hand, and we want to be triple darned sure it’s not going to hurt anyone. We also want to find a product that we can put in the hands of trained, medical personnel. We’re looking at new technologies—glues, foams, fibrins, even focused laser ultrasound waves—to stop bleeding,” DaCorta says.[PAGEBREAK]
Show Me The Science
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.”
Reality Checks
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.]
For More Information
QuikClot
www.z-medica.com
RDH Bandage
TraumaDEX
www.medafor.com
Urgent QR
www.biolife.com
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.
