"HemCon doesn't work," said Navy Capt. Peter M. Rhee, director of the Navy Trauma Training Center in Los Angeles and former head of the military's research laboratory in Bethesda.
Looking for solutionsThe Army's interest in stopping severe bleeding is as old as the service itself, but its push for innovative scientific solutions to warfare's most vexing medical problem was spawned 12 years ago by the deadly attacks in Mogadishu, Somalia. Holcomb, a Ranger doctor who treated casualties from the 1993 fight in which several soldiers bled to death, has focused much of his career on battlefield medicine and hemorrhage control since then.
One product of that effort has been a complete revision of the Army's recommended procedures for treating battlefield trauma, including greater emphasis on use of tourniquets and improved, combat-specific medical training for every soldier in the service. Whereas soldiers were once taught to use tourniquets as only a last resort, today they are trained to apply them as a primary treatment for combat injuries.
After an article in The Sun in March that detailed cases in which doctors questioned whether soldiers might have lived had they been equipped with the tourniquets Holcomb had been recommending since before the war, the Army issued 172,000 pre-made tourniquets to all of its uniformed personnel in Iraq and Afghanistan. Tourniquets have also been made standard-issue items for every soldier in the service.
Another advancement has been a succession of bleeding-control products developed or tested, with the help of several multimillion-dollar grants from the federal government, by the laboratory at Fort Sam Houston.
For much of the late 1990s, the Army's research efforts at the lab, which Holcomb oversees, centered on a bandage developed in cooperation with the American Red Cross that was treated with human blood proteins and is still regarded as one of the most promising blood-clotting agents ever devised. The Red Cross bandage, which showed a remarkable ability to coax human blood into forming a solid and stable clot, was distributed to special forces troops in Afghanistan as part of a large-scale trial in 2002.
But the trial was halted after one reported use - a successful one - and the program was mothballed because the dressing proved too unstable for mass production and too unconventional for easy approval by the Food and Drug Administration. It also cost roughly $1,000 apiece, though Army officials say the price never deterred their efforts to save lives.
Over the past decade, civilian researchers were also developing blood-clotting agents using such materials as potato starch and algae, and numerous scientists had been drawn to a substance called chitosan that is derived from the shells of insects and crustaceans. Perry R. Klokkevold, the director of postgraduate periodontics at the University of California, Los Angeles, worked with chitosan in the early 1990s as he searched for ways to control bleeding in dental patients, for instance, and he found that it appeared to promote clotting even in hemophiliacs.
"It's not a profound hemostasis - something you put on and the bleeding stops immediately," said Klokkevold, who halted the research when his commercial sponsor cut off funding. "But as an adjunctive treatment, it clearly had tremendous potential. I was very excited about it."
Around the time that Army researchers were struggling with the Red Cross dressing, scientists at the Oregon Medical Laser Center in Portland, Ore., developed a unique process of crystallizing chitosan from shrimp shells to form a flexible pad that seemed to have superior blood-clotting qualities. Army researchers flew to Oregon to watch the scientists press their chitosan pads onto bleeding pig arteries and were impressed by the results.
"We were just as skeptical as always, and maybe more skeptical because we already knew about some chitosan dressings that didn't work," said Anthony Pusateri, a research scientist who leads the Army's hemostasis program at Fort Sam Houston. "But this one, even in its early prototypes did a phenomenal job of controlling hemorrhage."
The Oregon scientists were operating under more than $7 million in Army research grants to explore ways to close traumatic wounds with lasers. But hoping to capitalize on their dressing's promise, they formed HemCon Inc., teaming up with retired Army Col. William P. Wiesmann, who oversaw their earlier grants when he served as director of combat casualty care for the U.S. Army Medical Research and Materiel Command at Fort Detrick.
With help from a new $400,000 grant from Wiesmann's former agency, HemCon got expedited approval from the U.S. Food and Drug Administration in November of 2002. It won a $2.45 million grant from the Army soon after and began delivering the dressing in small batches just as troops were preparing for the invasion of Iraq in early 2003. As of today the company has received roughly $29 million in grants and purchase orders from the Army, its sole customer.
Another productThe Marine Corps, meanwhile, had committed to QuikClot, an inorganic mineral that is said to have emerged as a medical product in the 1990s after a scientist applied some to a cut on a whim. Similar to volcanic rock, with a consistency that Marines often compare to cat litter, it comes in 3.5-ounce bags and is poured into a wound. In studies at the military's research laboratory in Bethesda, sponsored by the Office of Naval Research, QuikClot saved the life of every animal it was applied to, according to accounts of those studies published in the Journal of Trauma.
QuikClot is the flagship product of Z-Medica Corp. in Wallingford, Conn., which worked closely with the Office of Naval Research to develop and package the product, and which will have received roughly $150,000 in Navy research and development grants by the end of the year. The company sells QuikClot to law enforcement agencies, foreign militaries and others, but the Marine Corps has been its primary customer.
From its earliest studies, QuikClot displayed an obvious drawback - its tendency to create heat when mixed with a liquid, such as blood. But scientists say it also shows a consistent and extraordinary ability to stop bleeding quickly.