Trauma Medicine

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FEDERALLY-FUNDED RESEARCH CONSORTIUM TO GIVE MILITARY ANSWERS ON TRAUMA MEDICINE.


The military has long sought an answer for which IV fluid is the best to treat trauma on the battlefield. A collection of seven federal research agencies from the United States and Canada may help get that answer soon.
 
The Resuscitation Outcomes Consortium is a three-year, $50 million federally funded research program to improve survival rates from serious accidents and heart attacks. Research will begin the moment emergency medical personnel arrive on scene and will continue in the emergency rooms of 10 U.S. and Canadian cities.

“It’s a novel idea because trauma and cardiac arrest are very separate things,” said Colonel John Holcomb, an Army trauma surgeon and the only military member participating in the steering committee for the consortium. “What was recognized was that the pre-hospital groups that care for both groups of patients are exactly the same: You get on the ambulances and they come into the ER. If you want to study them, then all the systems are in place that you need to study them are there and can be utilized for both groups.”

The trauma track of the consortium has its roots in a workshop called PULSE, which stands for post resuscitative and initial utility of life saving efforts and was organized by the National Institutes of Health’s National Heart, Lung and Blood Institute. A trauma workgroup, of which Holcomb was a member, recognized that a “centralized, federal ‘home’ for trauma research does not exist,” according to an article printed in Shock, a medical journal.

The PULSE studies laid out a roadmap for what needed to be studied in terms of trauma, Holcomb said. “From a trauma point of view, that turns out to be the A, B, Cs—airway, breathing, circulation—which there is no data support for, which is kind of interesting,” he said. “There’s a lot of things that make sense, but medicine is replete with things that make sense that turn out not to be true. It’ll be interesting to see if this isn’t one of those times.”

The consortium’s trauma research is expensive but invaluable, especially considering that 40 percent of the 150,000 civilian patients who die from trauma do so before reaching the hospital. First to be studied will be the Cs, namely resuscitation fluids, which are given intravenously to help replace lost blood and keep blood flowing to vital organs in trauma cases. Three fluids will be given to trauma patients en route to the hospital: a standard resuscitation fluid called lactated ringers; high concentration saline, called hypertonic saline, or HS; and hypertonic saline dextran, which usually abbreviated HSD. The first is approved by the Food and Drug Administration, the last two have gone through a number of clinical trials but haven’t enrolled enough patients to gain approval.

“The data shows that the fluids are safe and they work,” Holcomb said. “We picked HS and HSD because there’s a large number of papers that say these fluids are safe in humans. We wanted to pick a fluid that is safe and yet still has real questions concerning efficacy.”

All fluids are not equal when it comes to their use in trauma. Lactated ringers, created in the 1800s for treating diarrhea, is most common and inexpensive, while HSD is costlier but providers can use fewer bags of them in comparison to lactated ringers to get good results. HSD is designed to replace blood loss more effectively while reducing inflammation. “If you put in a liter of lactated ringers in somebody, only 200 cubic centimeters (ccs) of that actually stays in the bloodstream; 800 ccs leak out into the tissues,” said Colonel Bob Vandre, director of the Army’s combat casualty care research program.
 
Further, Holcomb said, lactated ringers is probably not the best solution for treating trauma victims. “The ph is acidic compared to that normally found in the body, so if you were designing a fluid today to resuscitate trauma patients you wouldn’t design lactated ringers. But that’s what we use,” he said. “There are a lot of animal studies out there saying it’s probably not the best fluid, but translating animal work in 10 to 20 pigs to thousands of trauma patients is extraordinarily difficult.”

That’s where the consortium comes in. During the three years, as many as 8,000 patients will participate in the fluid studies that will give health care providers answers on the best fluid for trauma victims. Each medical center in the 10 participating cities will undertake information campaigns to educate communities on the trials through a process called community consent.

“A trauma patient doesn’t know in advance that he’s going to be a trauma patient,” Vandre said. “You can’t get individual— informed—consent from them... and most often you can’t get immediate consent of the next of kin, so you have to get consent of the community.”

Although the trials will take place in civilian hospitals, the results should directly translate to military medicine.

“While the injury mechanisms are obviously very different, the physiology of military casualties and civilian casualties are much more similar after injury than they are different,” Holcomb said. “Because we’re part of the consortium, to be honest, we have an opportunity to guide the research selection process, to make sure we get dual use, not only for the civilians but for the military.”

U.S. members of the consortium include the Department of Defense, the National Institutes of Health’s National Heart, Lung and Blood Institute, the NIH’s National Institute of Neurological Disorders and Stroke and the American Heart Association. Canadian members include the Canadian Institute of Health Research’s Institute of Circulatory and Respiratory Health, the Canadian Defense Research and Development and the Heart and Stroke Foundation of Canada.

Future studies include a valve designed to improve blood flow during CPR and novel studies to control hemorrhage. ♦

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