Military, civilian medical experts emphasize investment in acute trauma care

FORT LAUDERDALE, Fla. (Aug. 13, 2013) -- From battlefield blasts to plane crashes, major advancements in acute trauma care are being seen in both the military and civilian health sectors, agreed experts during roundtable discussion at the 2013 Military Health System Research Symposium, Aug. 13, in Fort Lauderdale, Fla. 

Funding in research and rapid implementation of best practices are paying off, and people with serious injuries are surviving and rehabilitating, said director of the U.S. Army's Combat Casualty Care Research, or CCCRP, Program Col. Dallas Hack. Joining him was Air Force Col. Todd Rasmussen, CCCRP deputy director.

"It's not an overstatement to say that trauma care has been transformed because of this investment," said Rasmussen. "This transformation has resulted in the lowest fatally rate for service members we have ever seen, and this investment has translated to civilians, including those injured on the streets of this country."

Roundtable participants included Navy Capt. Eric Elster, Uniformed Services University School of Medicine, Department of Surgery professor; Air Force Col. Jeffrey Bailey, Joint Trauma System director; and Dr. Margaret Knudson, chief of surgery at the San Francisco General Hospital and Trauma Center.

Bailey, who joined the event via phone from Afghanistan, talked about some of the technologies, tools, and education implemented over the past decade of war, including battlefield tourniquets, hemostat bandages to reduce blood loss, and education on first-aid care. Bailey said now it's time to "focus on the gaps."

"The greatest burden of death is not in the hospital; it is on the battlefield. So we have the greatest opportunity to make a difference in pre-hospital care," Bailey said to the group.

It was a point with which non-military doctors agreed. Knudson joined the group to share her recent experiences caring for victims during the San Francisco plane crash in July. Fifty-three of the plane crash patients were treated at San Francisco General.

Knudson explained that she had previously trained with military health care combat casualty teams and how she used that training during the mass casualty triage. 

"We need to keep these collaborations going because it brings a value to both the military and the civilian sectors," said Knudson.

Elster added, "It's how we train the next generation."

QuikClot goes Japanese

WALLINGFORD, Conn.--(BUSINESS WIRE)--Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced that it has signed an exclusive distribution agreement with Nihon-Kohden, Japan's leading manufacturer, developer and distributor of medical electronic equipment . The agreement allows Nihon-Kohden the exclusive right to distribute Z-Medica’s QuikClot line of hemostatic agents to hospital, military and law enforcement markets throughout Japan. The companies have been working together since early 2009 to obtain regulatory approval. Such approval for the sale of Z-Medica’s full line of QuikClot hemostatic gauze products was approved by the Japanese Ministry of Health, Labor and Welfare in March 2010.
“We are very pleased that we have signed this distribution agreement with Nihon-Kohden because of their longstanding positive reputation and vast reach throughout the Japanese market,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We believe that clinical practitioners outside of the US will find QuikClot to be a useful tool in achieving hemostasis in a fast, safe and convenient manner, and we intend to continue expanding our international distribution through best-of-breed partners such as Nihon-Kohden.”
QuikClot is a surgical gauze impregnated with kaolin, an inert material with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“We are very pleased to have this opportunity to market in Japan QuikClot which helps many patients who suffer from bleeding,” said Hiroshi Aida, General Manager of Import Business Operation, Nihon Kohden. “QuikClot also helps medical professionals with much shorter time for achieving hemostasis. It is a nice addition for our product portfolio.”
Z-Medica and Nihon-Kohden have been working together since early 2009 in order to gain the recently granted regulatory approval. The QuikClot line of products to be distributed by Nihon-Kohden in Japan include:
QuikClot Combat Gauze is a soft, white, sterile, nonwoven 3” by 12 feet rolled or z-folded gauze impregnated with kaolin. Each roll of QuikClot Combat Gauze is individually wrapped in an easy rip, military grade foil pouch. Indicated for temporary external control of traumatic bleeding, QuikClot Combat Gauze is flexible and pliable and contours to all wounds. Recommended as the number one hemostatic agent by the COTCCC (Committee on Tactical Combat Casualty Care Committee), QuikClot Combat Gauze is the only product carried by all branches of the US Military to control life-threatening hemorrhage.
QuikClot Emergency Dressing is an easy-to-use dressing which can achieve hemostasis in as little as three minutes, helping to prevent loss of life and limb. Because QuikClot requires very little training to administer, it can be effectively used by medical personnel, civilian first-responders and medical professionals in the field and in clinical environments. This dressing comes in various sizes, including a 4-ply 4” by 4” (10cm x 10cm) and a 6-ply 2”x2” (5cm x 5cm) format.
QuikClot Interventional Hemostatic Bandage consists of a soft, white, double sterile, hydrophilic pad impregnated with kaolin. It is double-wrapped in a blister package and foil pouch for aseptic technique. QuikClot Interventional Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of external bleeding from vascular access sites and percutantous catheters or tubes utilizing sheaths up to 12 Fr.
QuikClot Trauma Pad consists of a soft, white, double sterile, three-ply 12”x12” (30cm x 30cm) pad impregnated with kaolin. It is double-wrapped in a peelable foil package for aseptic technique. QuikClot Trauma Pad is indicated for temporary external use to control traumatic bleeding and is also x-ray detectable to ensure proper removal.

About Z-Medica

Z-Medica Corporation is a medical device company developing innovative hemostatic agents. The company manufactures and markets its QuikClot® family of products for hemostasis for use by healthcare professionals, first responders, law enforcement officers and the military. QuikClot products rapidly enhance the body’s natural coagulation process, helping to achieve hemostasis faster. Z-Medica’s QuikClot® Combat Gauze™ product was chosen by the Committee on Tactical Combat Casualty Care (TCCC) as the United States Military’s sole source supplier for first-line hemostatic treatment, based on tests conducted by the Naval Medical Research Center and the U.S. Army Institute for Surgical Research. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage. QuikClot® products are also widely used by first responders, in hospital emergency rooms, interventional cardiology and radiology laboratories and other healthcare environments where bleeding requires fast and effective control. Z-Medica, named one of the Top 100 Technology “Companies to Watch” in 2008 by the Connecticut Technology Council, is a privately-held company based in Wallingford, CT. More information about Z-Medica Corporation is available at www.z-medica.com.

About Nihon Kohden

Nihon Kohden is Japan’s leading manufacturer, developer and distributor of patient monitors, defibrillators, ECGs, EEGs, EP/EMGs, hematology analyzers and other medical electronic equipment, with subsidiaries in the United States, Europe, and Asia, and distributors in nearly every country in the world. Nihon Kohden is a publicly held company listed in the First Section of the Tokyo Stock Exchange. In addition to designing medical equipment for hospital and clinic use, Nihon Kohden actively contributes to the advance of medical technology.

US Military faces challenges from Chinese Knock-offs

As anyone who has served in combat knows, if a buddy is wounded, the first two things you need to do are make sure he can breathe and his bleeding is stopped.
For the past several years, troops serving in Afghanistan and Iraq have used an advanced Combat-Application-Tourniquet (C-A-T) developed by Composite Resources in Rock Hill, S.C. The tourniquet features a nylon strap and a plastic rod to tighten the strap to stop bleeding.
The regulation C-A-T costs about $28. But about two years ago the Army detected cheap knock offs made by a Hong Kong company that had entered the military's supply chain in Afghanistan and Iraq. The imitation sold for about $8.50.
They're accurate looking fakes, right down to the label and national stock number.
But as Col. John Kragh, a doctor at the U.S. Army Institute of Surgical Research at Fort Sam Houston, pointed out in June, the rod on the fake tourniquet "is bendable to a point where it cannot work right. It's like bending Gumby's arm."
He said the fake tourniquet could be fatal because it cannot stop bleeding. Kragh added a decentralized ordering system probably accounts for the presence of the fake tourniquets in the field, with low-level supply personnel ordering the knock offs over the Internet based on price.
The Defense Department issued a warning about the knock-offs in April, Kragh said, and the Food and Drug Administration this month put out a safety alert about the tourniquets, which are also used by civilian first responders.
The lesson here is a good deal isn't always that; it can even be deadly.

Poll Result - Which Geographical Manufacturing Area for Hemostatic Devices Causes Concern?

Controversies

2007 Chinese Export Recall

The 2007 Chinese export recalls were a series of scandals involving tainted food and products exported from China, starting with tainted pet food imported from China to the United States that poisoned pets. The recalls sparked international concern that many products made in China do not meet minimum quality standards. Soon after, the US halted imports of seafood from China after tests detected the presence of drugs unapproved in the US.China has gone on record to admit that nearly a fifth of products made in China do not reach minimum standards. Also, some children's toys made in China were found to contain excessive levels of lead, prompting widespread concern. In 2006, shipments of cough syrup and other medicines, imported from China to Panama and laden with the toxin diethylene glycol, caused mass poisonings and killed 83 people.
On December 19, 2007, The US House of Representatives passed legislation (H.R. 4040) that would significantly amend the current U.S. safety establishment for consumer products imported from China.

2008 Chinese heparin and milk scandals

In March 2008, major recalls of heparin were announced by the U.S. Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China.
The raw material for the recalled heparin batches was processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories. The U.S. Food and Drug Administration was quoted as stating that at least 81 deaths were believed linked to a raw heparin ingredient imported from the People's Republic of China, and that they had also received 785 reports of serious injuries associated with the drug’s use. According to the New York Times, "Problems with heparin reported to the agency include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock."
Upon investigation of these adverse events by the FDA, academic institutions, and the involved pharmaceutical companies, the contaminant was identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish-derived supplement often used as a treatment forarthritis. Since over-sulphated chondroitin is not a naturally occurring molecule, costs a fraction of true heparin starting material, and mimics the in-vitro properties of heparin, the counterfeit was almost certainly intentional as opposed to an accidental lapse in manufacturing. The raw heparin batches were found to have been cut from 2-60% with the counterfeit substance, and motivation for the adulteration was attributed to a combination of cost effectiveness and a shortage of suitable pigs in China.
When the FDA conducted an inspection of Baxter's Chinese Heparin supplier, it found serious deficiencies at the facility which the FDA detailed in a warning letter.
The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas manufacturers of active pharmaceutical ingredients such as heparin.
In November 2008, the FDA seized eleven lots of heparin from Celsus Laboratories Inc., a manufacturer in Cincinnati, Ohio.

One year later, the 2008 Chinese milk scandal refers to a food safety incident in mainland People's Republic of China involving milk and infant formula which had been adulterated with melamine, an organic base combined with formaldehyde to form plastic. The result was catastrophic - By 22 September, nearly 53,000 illnesses, over 12,800 hospitalizations, and four infant deaths had been reported, caused by kidney stones and other renal failure.The chemical appeared to have been added to milk in order to cause it to appear to have a higher protein content. The same chemical was also involved in a series of pet food recalls in 2007. In November 2009, two individuals were executed for endangering public safety and producing and selling toxic food.

2009 Made in India scandal

In June 2009, the Nigerian Government Drug Regulatory Authority (NAFDAC) reported about the detention of a large consignment of fake anti-malarial generic pharmaceuticals labeled Made in India but produced in China. The Laboratory analysis conducted by NAFDAC revealed the drugs to be fake and had it not been intercepted, about 64,200 adults would have been affected. The consignment containing Maloxine and Amalar tablets, used for the treatment of Malaria, were valued at 32.1 million Naira and were produced, packed and shipped from China. After Indian Authorities took up the matter, The State Food and Drug Administration (SFDA) of China was asked to investigate the matter[10]. In December 2009, 6 chinese traders were sentenced to death for their involvement.
In July 2009, customs officials in the South Indian port city of Chennai seized spurious cosmetics and mobile phone batteries worth Rs. 30 million, imported into India from Scheko in China. The 40 foot container was held up at the port for more than 75 days and opened on 13th July when the importer did not file a bill of entry. It was reported to contain over 187,000 batteries with Nokia holograms and stickers, and 126,000 cosmetic items including face packs, lipsticks and hair gels.

Further Reading - "These are not isolated cases," Han Yi, director of the administration's quality control and inspection department, told the state media. Underlining his concerns, officials said hundreds of bottles of fake human blood protein were found in hospitals......

Also - Federal drug regulators, in announcing Wednesday that the mystery contaminant in heparin was an inexpensive, unapproved ingredient altered to mimic the real thing, moved closer to concluding that Americans might be the latest victims of lethal Chinese drug counterfeiting.

And - There also seems to be agreement that our regulatory agencies can’t rely on China to police its own factories. The Chinese have lurched between vows of reform and disregard for American concerns about the quality of the country’s products.

‘War is the only proper school for surgeons’

BALAD, Iraq — Army Dr. Colin Meghoo stared at the dry-erase board at Baghdad’s Ibn Sina Hospital. In black marker were the names of the injured, and the procedures chosen to try to save their lives — many of which he had never seen performed.
It was September 2005, and Meghoo, now a lieutenant colonel, had just completed his surgical residency. Trained in repairing the car crash injuries and the occasional gunshot wound that trickled into his Texas emergency room, he now was confronted with the devastating and hugely varied wounds of modern warfare: legs and arms mangled by explosions, arteries severed by bullets, vital organs peppered with shrapnel.
“It was a bit overwhelming,” he recalled, “but then you think to yourself, ‘Wow, this doesn’t even exist in busy civilian hospitals. You need to be in a war zone to see this.’ ”
The ancient Greek physician Hippocrates said that “war is the only proper school for surgeons,” and the war in Iraq has been just that, but with an important development: Lessons were learned and shared immediately.
In the past, doctors had to wait until the gunfire stopped before examining what lessons had emerged.
There are dozens of volumes just about World War II, published long after the war, said Air Force Dr. (Lt. Col.) Raymond Fang, trauma director Landstuhl Regional Medical Center in Germany.
But in Iraq, improvising surgeons and up-to-the minute observational research have resulted in techniques that helped troops survive at a greater rate than in any previous war. Some are high-tech and novel; others were rediscovered; and a few are reinterpretations of old protocols. Moreover, these lessons were documented and shared as the war raged.
Military surgeons have been able to rewrite the book on trauma before U.S. troops have even left the country. “War Surgery in Afghanistan and Iraq: A Series of Cases, 2003-2007” was published by the U.S. Army in 2008, detailing 83 cases from 53 battlefield
doctors.
Now the lessons and techniques tested in Iraq are being honed in Afghanistan, and new ones are being explored.
“It’s not about the next war anymore,” Meghoo said, who recently completed his second tour at Forward Operating Base Sharana near the Afghanistan-Pakistan border.
The advances are needed now.

Stopping the blood
Wars have always birthed medical advancements.
During the Civil War, physicians found new ways to amputate limbs and began using rags soaked in chloroform to anesthetize patients. The typhoid vaccine was developed during World War I, when an Army officer also established the first blood depot. World War II brought the mass use of penicillin, and the Korean War, helicopter evacuation.
One of the legacies of Iraq is a new emphasis on stopping blood loss. Better body armor and helmets protected troops’ vital organs, but high-velocity bullets, rocket-propelled grenades and roadside bombs inflicted the exposed limbs with massive, bleeding wounds.
To stanch the bleeding, doctors turned to one of the oldest and simplest tools in battlefield medicine: the tourniquet. Tourniquets had been maligned and shunned since World War II because of fears that they caused gangrene and limb loss. They do, when used for long periods — but faster evacuation and hospitalization combined with tourniquets saved hundreds of lives in Iraq. A 2008 review of records at the 31st Combat Support Hospital in Baghdad showed that four in seven deaths could have been prevented had a tourniquet been used before the patient arrived.
“This is a simple mechanical thing done since the time of the Egyptians,” Fang said, “and now it’s returning.”
Soldiers in the field are issued one combat application tourniquet, or CAT; some carry more than half a dozen. Slipped around a limb, the tourniquet’s nylon strap is cinched, and the plastic bar on top is twisted, crimping the artery below. The lever is cranked with one hand, so servicemembers can secure their own tourniquets even when badly injured.
Sgt. Chris Bickford, a combat medic who has deployed to Iraq twice, said he trains all his soldiers to clamp on a tourniquet in less than 12 seconds.
“Before we could only use pressure dressings, and there was the chance you may lose the life,” he said. “Now the way the tourniquets are built, allowing them to be placed high on the limb — that saves lives.”
At the start of the Iraq war, innovative clotting agents such as QuikClot were also poured into open wounds. QuikClot, a loose substance made of synthetic absorbents that looks like dry clay, draws water from blood, helping it coagulate. But surgeons often had to pick out the sticky granules, and in some cases QuikClot burned tissue, or even the eyes of the patient on a windy day.
QuikClot’s manufacturer, Z-Medica Corp., soon replaced the loose product with a bag filled with the clotting agent, then, finally, combat gauze treated with it. Medics in the field now push the gauze into wound cavities. The gauze is “easier to carry and much more comfortable for the patient,” Bickford said.
Now the military is looking for alternatives to these synthetic materials, Fang said. One possibility is dried plasma, the liquid part of blood that has proteins and clotting factors. The dried plasma would be revived in a saline solution and then given to wounded troops intravenously or injected into the bone marrow. The latter technique keeps medics from having to search for a vein, a difficult task when soldiers are covered in thick packs and bleeding, said Col. Dallas Hack, director of the Combat Casualty Care Research Program.
“The bone marrow is a fairly large area,”” Hack said, “and you can do it by feel.”
Clinical trials of two forms of dried plasma, one freeze-dried and the other spray-dried, are under way, and it could be in the hands of medics within three to five years, Hack said.
Fang said long-held conventions about blood transfusions also changed. Doctors once pumped saline into hemorrhaging patients to restore hydration, and then added red blood cells and extra platelets. Now surgeons try to “emulate whole blood,” Fang said, forgoing saline and pumping in equal amounts of platelets, cells and plasma.
Before the war, surgeons had regarded the freshness of donor blood as unimportant — as long as it was used within a two-month window. But downrange doctors discovered that fresher red blood cells carry more oxygen, which keeps vital organs working better and provides more oxygen to the brain, helping prevent comas.
“There is a push downrange to use blood that is 14 days old or younger,” Fang said.
At forward operating bases in Iraq, loudspeakers often called for blood donors during periods of heavy fighting. Troops lined up at combat hospitals to donate as the wounded were carried in.
It’s a procedure that has continued in Afghanistan, Meghoo said, even at small outposts.
“You’d put the call out,” he said, “and people would just descend.”
Surgeons like Meghoo also practiced closer to the battlefield than in previous wars, often in the dusty tents of forward operating bases. There, teams lacked many resources of typical trauma hospitals, including imaging equipment such as CAT scanners and fluoroscopes. But they performed minimal yet crucial operations to stabilize a patient, often within the critical “golden hour” after injury, said Dr. (Col.) David P. Blake, director of trauma at the Balad hospital. After the initial lifesaving surgery, patients were taken to Balad, where they were warmed up and given fluids, allowing them to recover enough for the next surgery.
“You control what is immediately going to kill them,” Blake said, “and then you come back another day to address the details.”
Roadside bombs mangled limbs, leaving many soldiers amputees. To prevent this, surgeons improvised with shunts, tiny plastic tubes placed into damaged blood vessels. The combat surgeons found the shunts, which had been used occasionally by vascular surgeons, indispensable to keep blood flowing to troops’ injured limbs, hands or feet until the damaged vessels could be repaired.
Meghoo, for example, had a patient in Afghanistan who was shot in the leg by a high-velocity bullet. The patient’s femoral artery had been severed, and worse, the bullet had burned the edges of the artery, causing it to contract.
“That’s a huge hole,” he said, showing a picture of the gaping wound. “And I can’t sew the [artery] back together because the ends don’t reach anymore.”
To control the flow of blood, Meghoo placed two shunts into the patient’s leg, one in the artery and the other in the vein, and sent him on to another hospital for further care.
In previous wars, Meghoo said, he likely would have bled to death or lost a limb.

Battlefield advances

Devices developed at civilian hospitals were also brought to the battlefield, where doctors found new uses for them.
Before 2004, doctors opened and cleared wounds of blood-soaked gauze and other debris twice daily, a treatment that was painful for patients, but needed to keep their wounds clean. The frequent changing of dressings was common practice for centuries, Fang said, until surgeons at Balad experimented with a vacuum that sucks away the excess fluid, allowing a wound to be sealed for nearly three days.
With negative pressure wound therapy, the wound cavity is covered with a clear plastic bandage with a suction tube attached, then vacuum-sealed. Designed for chronic wounds, the suction helps troops’ tissues heal faster “because all that wound soup is not staying around,” said Lt. Col. Joe Sniezek, director of the Seventh Joint Combat Casualty Research Team.
Better still, patients on long evacuation flights no longer need to have their bloody dressings removed and cleaned in transit.
“It remains to be seen whether the outcome is better,” said Fang, “but it definitely makes it more comfortable for the patients.”
Several high-tech devices were tested for the first time on troops, including an infrared camera that helps doctors detect compartment syndrome, a crimping of the blood vessels in the leg or arm. Deep wounds cause muscle inside the limb to swell, potentially leading to gangrene. The only way to relieve the pressure, or even diagnose compartment syndrome, is to flay the leg or arm muscles open.
The surgery works, said Sniezek, but it’s a “morbid procedure, making an incision all the way down the limb.”
The infrared device, however, allows doctors to detect any difference between the temperatures of the body’s core and the limbs, an indicator that blood is not flowing correctly. If the temperatures are within normal range, surgeons can potentially avoid an unnecessary opening of the limb.
“This is a nice example of how new technologies are being integrated here on the battlefield,” said Sniezek, “and the study is now moving to Afghanistan.”
A cardiothoracic surgeon at Landstuhl was the first to save a patient with the Novalung — a simple-looking slender box with a complex membrane inside that acts as a temporary lung. It connects to blood vessels in the groin, allowing blood to flow from one leg into the box, where it passes through a filter that leaches off the carbon dioxide and infuses the cells with oxygen, mimicking the trade-off that takes place naturally in the lungs. The refreshed blood then returns to body through the other leg.
Unlike a heart-lung machine, the Novalung doesn’t require a mechanical pump because it “works off the body’s own blood pressure,” Fang said.
Approved by European regulators but not yet by the U.S. Food and Drug Administration, the Novalung has been used successfully on about a dozen troops transported to Landstuhl, Fang said. But each time they use it, doctors must submit to the FDA that it is being used to save a life.
“Every time there is a war we learn a lot, because we have to,” said Fang. “And what you learn over years of time is condensed.”
Meghoo recalled using the many lessons that he learned in Iraq during his recent deployment to FOB Sharana, where he was one of two surgeons working in a shed.
“It could be a very lonely feeling,” he said of being away from the safety net of a large hospital with many specialists. “You can’t pass things off to anyone else, and these people have big problems, and you are the only one who can fix them.”
On one occasion an Afghan woman had her right shoulder severed in a mortar attack. Blood gushed from the wound, making it impossible for Meghoo to reach the artery.
“It’s the equivalent of a fire hydrant,” he said. “You can’t go through the water to find the hole. You have to know where the shut-off valve is.”
Meghoo removed part of the woman’s collarbone, and then stemmed the flow of blood by temporarily cinching the artery.
“I remember that case,” he said, “because it was a skill I didn’t have until after I deployed to Iraq.”
The techniques discovered by military surgeons are trickling down to civilian hospitals as well, said Dr. James Dennis, a visiting vascular surgeon at Landstuhl who choked up while talking about the troops with catastrophic injuries whom he had treated in the intensive care unit.
“You can’t help but be moved by what these young people are going through,” said Dennis, whose 25-year-old son Trevor is in the Marines.
Dennis practices at a hospital in Jacksonville, Fla., that recently adopted the military’s protocol when giving blood transfusions to patients with massive injuries.
“They used to learn from us,” Dennis said of military surgeons. “Now we learn from them.”

Combat casualty care conference shows promising research returns

Top scientists gathered this week at an annual conference to discuss therapies for traumatic brain injuries and lifesaving medical tools to deploy to the battlefield. The annual Advanced Technology Applications for Combat Casualty Care Conference, which is being held this week in St. Pete Beach, Fla., includes presentations on topics ranging from regenerative medicine to pain control to more sensitive vital system monitors. But the two biggest issues talked about were traumatic brain injury and hemorrhage research, said Col. Dallas Hack, director of the Combat Casualty Care Research Program in the U.S. Army Medical and Materiel Command at Fort Detrick.
"We want to save the most lives we can, and that's hemorrhage," Hack said during a phone conference Tuesday morning.
Col. Lorne Blackbourne, commander of the U.S. Army Institute of Surgical Research in San Antonio, Texas, said his command presented a paper on Monday showing that half of the service members who died of injuries suffered "potentially survivable" wounds. Eighty percent of those were hemorrhages, Blackbourne said. Of those hemorrhages, 30 percent were in the legs and arms, where a tourniquet can be used to stop bleeding; 20 percent were in the neck, groin, armpit and areas where a tourniquet cannot be used but pressure can be applied to stop bleeding; and 50 percent were in the chest or abdomen, where pressure cannot stop the bleeding.
Blackbourne said combat medics are better trained than ever before and the tourniquet technique, in use for about 300 years, is "the most valuable piece of equipment" in the battlefield. He said the more certain way of saving lives is to find ways of bringing blood products to the field though.
In the civilian world, bleeding patients may be pumped with salt water or other clear liquids to keep their blood pressure up until they reach the hospital in a matter of minutes. In a combat zone, on the other hand, bad weather or enemy fire may keep a bleeding service member from being airlifted to a hospital for hours. Without plasma to promote clotting, or a blood transfusion, the patient can bleed to death before reaching the hospital.
Hack said two products showcased at the conference, which is sponsored by the Department of Defense, may be approved for use within a few years. Freeze-dried plasma is already in human trials, and spray-dried plasma is about six months behind, he said.

Hemostasis, Control of Bloodloss - War, EMS, Military,First Resonders, Ambulance

EMS Hemostasis Articles

Woundstat halted by US army

WASHINGTON — Until more testing can be done, Army medics are being told to stop using a new product just sent to the war front to help control bleeding among wounded troops.
Officials were in the process of distributing some 17,000 packets of WoundStat, granules that are poured into wounds when special bandages, tourniquets or other efforts won't work. But a recent study showed that, if used directly on injured blood vessels, the granules may lead to harmful blood clots, officials said Tuesday.
The Army Medical Command will continue its research and work with the manufacturer in hopes of figuring out in the next few months whether to resume use of WoundStat, said Col. Paul Cordts, head of Army health policy and services.
WoundStat manufacturer TraumaCure, Inc., of Bethesda, Md., had no immediate comment.
The product had been approved by the U.S. Food and Drug Administration. It was one of the latest in a series of Army efforts to improve survival rates on the battlefield.
Today, 90 percent of injured troops survive their wounds, the highest rate of any war, Cordts said in an interview. He credited better training of combat medics, better body armor the troops wear and better tactics they use on the battlefield, as well improved bandages, tourniquets and so on.
Defense Department figures show that as of this month, more than 4,800 troops have been killed in Iraq and the global war on terror. The latter category counts casualties mostly from Afghanistan. Some 34,000 troops have been wounded in the wars, where insurgents have made wide use of roadside bombs and other explosives.
Excessive blood loss is the number one killer on the battlefield, and the Army announced in October that it was sending two potential lifesavers ‹ the WoundStat packets and a bandage called Combat Gauze to replace older other products that had been in use at the time.
A committee of Army medics, Navy corpsmen, surgeons and others recommended the Combat Gauze bandage which has an agent that triggers blood clotting should be the first-line treatment for life-threatening hemorrhaging in cases where a tourniquet could not be placed, such as the armpit or groin area.
The WoundStat granules were to be used if the bandage failed to work.
Cordts said the Army put out a message on Dec. 18, directing the temporary halt in use of WoundStat. Though it has arrived at the war zones, officials are unclear on how widely it has been distributed so far. They¹re working to identify any soldiers who got the treatment, study their cases and examine them for any problems with blood clotting, Cordts said.
He said he didn't know whether it had been used on any soldiers and thus had no reports back from the field positive or negative on how effective it might have been.
Cordts said that after an additional few months of study, officials will likely determine whether they should discontinue its use altogether or perhaps redistribute it with warnings for how it is to be used.

Cold Plasma Technologies with Medical Potential Get Licensed

Drexel University’s plasma medicine technologies were licensed to Plasma Technologies, Inc.(PTI), a Texas-based company that intends to design, patent and market medical devices related to wound healing and care, prevention of hospital borne infections, and other medical applications. The technology may have near term impact not only in civilian healthcare settings, but also on the U.S. military applications.
“We are pleased to have PTI as a partner to commercialize the plasma medicine technologies,” said Dr. Ken Blank, vice provost for research at Drexel. “PTI has the expertise to bring the technology through clinical trials and FDA approval so that this breakthrough technology can be used to benefit patients.”
Found in fluorescent light bulbs and high-end televisions, non-thermal or cold plasma can also be used in medicine, as Drexel researchers discovered. Part of what makes this technology so desirable is that small amounts of energy are used instead of chemicals in the medical process.
The researchers found that cold plasma can kill bacteria (including B. anthracis which is a causing agent of anthrax, E.Coli, Streptococci and Staphylococci) on living tissue within seconds without causing side effects. Cold plasma can also stop bleeding, making it effective in some surgical procedures and in treating intestinal ulcers and persistent nosebleeds. For example, a severe wound that might bleed for 10-20 minutes was stopped after only 15 seconds of plasma exposure and with no tissue damage. Initial findings also show cold plasma can promote the growth of some human cells at doses slightly greater than those needed to kill bacteria.
Cold plasma produces medical effects by enhancing biochemical processes that would either occur slowly or not at all, researchers in the Plasma Institute say. For the same reasons, cold plasma has already found many uses in fuel conversion and hydrogen production, energy systems and aerospace engineering, environmental control and material and waste treatment.
Prototype medical devices have been designed with the participation of PTI’s surgeons to address needs in trauma and plastic surgery, and to augment healing in acute and chronic wounds. These devices have immediate applications in the battlefield, emergency rooms, rehabilitation centers and cancer treatment centers in the military as well as international and US civilian markets.

Comparison of Celox, Hemcon and Quikclot

Celox sent me this report comparing Hemcon and Z-medica with Celox HERE (its a verified safe Pdf download from adrive).
Given the positive results I was left wondering why this product was not the sole choice of the Military, in particular the US forces?
So I emailed Craig Hardy, CEO, MedTrade Products Ltd and asked him........

Me: According to the Jan. ’08 Portsmouth pdf study (comparing Celox with Hemcon and Z-medica’s, Quikclot) the results indicate Celox shows a 100% survival rate. Is this product currently undergoing any evaluation by the military?

Craig: Yes. Celox is used in some performance critical areas of the military and being evaluated in many others. Its an ongoing process.

Me: Given that Medtrade is a U.K. based company what (if any) impact has this had for the uptake of Celox by the U.S. military?

Craig: In the US, Celox is distributed to the Military through Sam Medical in Portland Oregon. The UK is a very close ally of the US. We have heard of no decisions made on the basis of location. However our head office location means we are not as politically connected as some competitors and I believe this may have a significant effect.

US Department of Defense Recommends Soldiers Carry WoundStat™

BETHESDA, Md.--(BUSINESS WIRE)--TraumaCure Inc. announced today that the DOD Joint Committee on Tactical Combat Casualty Care (CoTCCC) has recommended that U.S. soldiers from all services carry the company’s hemostatic agent, WoundStat™. The CoTCCC based its recommendations upon the results of extensive studies conducted by both the Army’s Institute for Surgical Research (ISR) and the Naval Medical Research Center (NMRC). In those studies, no other product was as effective across the board in terms of survival, post treatment blood loss, and duration of hemostasis.
This is the first time ever that all branches of the military have come together and jointly recommended the same product for the most severe injuries involving high-pressure bleeding.
“Severe bleeding is the number one cause of death for soldiers injured in battle. The ISR study clearly shows WoundStat works consistently to stop serious bleeding quickly. In light of these study results, WoundStat will be a critical product in the field available to all soldiers in harm’s way, where and when it is needed most,” said Ron Blanck, retired US Army Surgeon General. “Approximately 80% of injuries in the current conflict are from improvised explosive devices (IEDs), which result in the severe and irregular wounds that WoundStat is specifically designed to treat. In those situations, WoundStat works in seconds, not minutes.”
Four different studies—including the one conducted by the Army’s ISR, along with others conducted at Virginia Commonwealth University, the Air Force, and NAMSA—have now proven that WoundStat is the most effective hemostat available for high pressure arterial wounds. In each of these studies, WoundStat was the only product that resulted in 100% survival. The novel wound treatment works through standing blood and has the added advantage that, should re-bleeding occur, a wound can be re-packed with the WoundStat already present—a real advantage in combat conditions.
“The Joint Committee on TCCC recognized WoundStat’s overall advantage in both effectiveness and safety. It is now clearly proven that, with its consistent reliability and efficacy, combined with its speed of use, WoundStat offers the highest level of operational field capability for our warfighters,” noted Devinder S. Bawa, CEO of TraumaCure.
TraumaCure has enough WoundStat in stock to equip every soldier currently deployed in the Middle East theater. The cost of WoundStat is about one-third that of the product the Army has been using for the past several years. WoundStat is also available for domestic use by emergency responders and others who need to be prepared for treating traumatic injuries.

Celox-A delivery system

Just recieved the Video of Celox-A delivery system I would like to share with you all below and the Pdf downloadable from Adrive and verified safe HERE

HemCon Medical Technologies Leverages Sangui Technology to Expand its Wound Care Products Line

PORTLAND, Ore.--(BUSINESS WIRE)--HemCon Medical Technologies Inc. today announced it will use Witten, Germany-based SanguiBioTech GmbH’s ChitoSkin technology platform to help further innovations in hemostatic bandages and wound care dressings for the acute care market.
Under the terms of the agreement, HemCon will leverage Sangui’s technology platform to enhance and expand its product offerings for surgical and wound care. HemCon developed the chitosan-based hemostatic HemCon® Bandages and ChitoFlex® dressings that are used by military and medical first responders as well as health care professionals around the globe.
“We explored a wide variety of technology platforms to add to our new surgical and wound care offerings and feel that the Sangui chitosan platform offers great opportunities to enhance our solutions,” said John W. Morgan, president and CEO of HemCon. “We’re committed to continuing our investment to develop new choices for medical professionals and consumers. This agreement is an important step forward in realizing the full potential of chitosan-based products.”
SanguiBioTech GmbH is a wholly owned subsidiary of Sangui BioTech International, Inc. Sangui BioTech International focuses on vascular and hemostasis products. The firm specializes in developing oxygen-carrying agents to treat blocked arteries, anemia or acute blood loss through SanguiBioTech GmbH.
“We are proud to enter into an agreement with HemCon and offer our chitosan platform to help innovate new surgical and wound care products,” said Sangui Managing Director Hubertus Schmelz. “There is definitely a demand for products that can adapt to specific medical needs, especially as it relates to wound care.”
HemCon retains exclusive worldwide market and distributing rights for products developed under this structured financial agreement. HemCon will submit developed products for U.S. approvals to the FDA, while Sangui will prepare documentation for registration in the European Union.

Therus Corp.

Therus Corporation is developing the Therus® Acoustic Hemostasis System, a medical device designed for rapid, durable, noninvasive sealing of femoral artery access punctures following catheterization-laboratory procedures such as angiography and angioplasty.
While the Company is pursuing femoral artery sealing, there are numerous other potential clinical applications for therapeutic ultrasound. These applications are being evaluated by AcousTx Corporation, a spinoff company of Therus. The product launch is planned for 2008.

HemCon completes acquisition of Alltracel Pharmaceuticals

HemCon Medical Technologies Inc. said Wednesday it has completed the acquisition of Dublin, Ireland-based Alltracel Pharmaceuticals in a cash-for-stock deal.
The purchase occurred through Castlerise Investments Ltd., a newly formed wholly owned subsidiary of HemCon. Alltracel will operate as a wholly owned subsidiary of HemCon and maintain its headquarters in Dublin. Combined revenue is expected to exceed $100 million.
Alltracel licenses their proprietary technologies across a wide spectrum of industries in the wound care markets. In addition, Alltracel offers private-label oral care products licensed in Europe through the Butler and GUM brands. The acquisition expands distribution opportunities for HemCon's KytoStat Bandage and other products in Europe while also expanding Alltracel's oral care products and medical technologies in the United States.
"We look forward to combining our resources and continuing to innovate," said John W. Morgan, CEO of Portland-based HemCon, in a statement. "The acquisition further strengthens HemCon's ability to develop health care breakthroughs and life-saving technologies on a global scale."
HemCon develops and makes products that control bleeding and infection resulting from trauma or surgery.
The company's signature product is a bandage -- made from material extracted from shrimp shells called chitosan -- that bonds to severe wounds within minutes of being applied.
Source Portland Business Journal

U.S. Department of Defense Picks New QuikClot(R) Combat Gauze(TM) as First-Line Hemostatic Treatment for All Military Services

WALLINGFORD, Conn., May 14 /PRNewswire/ -- Z-Medica Corporation (Z-Medica), a medical products company focused on innovative blood clotting nano-technologies, announced that the United States Department of Defense has selected the company's newest hemostatic product, QuikClot(R) Combat Gauze(TM) brand, for all military services as the first-line hemostatic treatment for life-threatening hemorrhage that is not amenable to tourniquet placement. Bleeding is the number one cause of death for soldiers injured in battle and QuikClot(R) products offer the most effective solution to severe blood loss outside the operating room setting. They have been proven in battlefield use and, with more than one million units deployed, are the leading hemostatic agents in the field.
The Committee on Tactical Combat Casualty Care (CoTCCC) made the decision to recommend QuikClot(R) Combat Gauze(TM) after reviewing test reports on a number of hemostatic products. QuikClot(R) Combat Gauze(TM) was the only one of these products tested by both the Naval Medical Research Center and the U.S. Army Institute for Surgical Research. In addition to test efficacy, the committee sited a number of other factors in according QuikClot(R) Combat Gauze(TM) the number one position: -- Preference for the gauze delivery format, which is familiar to combat
medical personnel.
-- Ability of QuikClot(R) Combat Gauze(TM) to be shaped to any wound and
to reach bleeding vessels in penetrating wounds.
-- Ease of removal once hemostasis has been achieved.
"Z-Medica's approach to product innovation has always been to listen to the voice of our customer and to focus our research & development efforts on delivering life-saving products that meet their needs," said Z-Medica CEO Raymond J. Huey. "With QuikClot(R) Combat Gauze(TM) we have provided a product that is virtually 100% effective in a very intuitive format that can be applied quickly and simply by anyone."
QuikClot(R) Combat Gauze(TM) combines surgical gauze with a proprietary inorganic material that stops arterial and venous bleeding in seconds -- even more rapidly in this format than earlier Z-Medica products. Based on a different mineral than zeolite-based QuikClot(R) products, it generates no heat. It shares the benefit of being inert and non-allergenic. QuikClot(R) Combat Gauze(TM) comes in rolls four yards long by three inches wide.
In addition to the military testing, the new product was tested in pre-clinical trials at the University of California, Santa Barbara, the University of Massachusetts Medical School and at various field facilities. It has 510(k) clearance from the U.S. Food & Drug Administration. The United States Department of Defense has awarded Z-Medica a $3.2 million grant for large-scale testing of the product on penetrating wounds. These multi-center clinical trials will take place during 2008.
Earlier QuikClot(R) products are in use by all branches of the U.S. Military, by first responders and security agencies across the U.S. and in 36 countries worldwide, with more than a million units in distribution. Z-Medica recently launched its first products for consumers.

U.S. Army Selects HemCon Medical Technologies as Sole Source Partner to Develop Lyophilized Human Plasma

The U.S. Army has selected HemCon Medical Technologies Inc. as the sole source to develop, test and secure FDA approval for a lyophilized (freeze-dried) human plasma (LHP) product and delivery system. The $15.4 million multi-year cooperative agreement will support the research and development of the new process. The project is expected to be complete in 2010.
The use of plasma as a resuscitation fluid, according to early U.S. Army studies, has shown to significantly reduce battlefield mortality. In many situations, use of fresh frozen human plasma is limited by storage requirements and the short shelf-life for thawed plasma. As a life-saving measure for coagulopathy, the US Army Medical Research and Materiel Command has identified the LHP initiative as a high priority. The new LHP product and delivery system will offer individual units of single source donor plasma that are safe and easy to carry, reconstitute and administer.
HemCon previously partnered with the U.S. Army to develop the HemCon® Bandage. Since 2003, HemCon has produced and distributed the HemCon Bandage and ChitoFlex® dressings for the U.S. Army and other military and civilian medical professionals. The chitosan-based hemostatic dressings, manufactured using a proprietary process, are currently included in every U.S. soldier’s battlefield first-aid kit. The success of the HemCon Bandage led to improved civilian patient care when the bandage moved to acute care facilities in 2007.
Leveraging a core competency in lyophilization, HemCon plans to do the same with its LHP initiative – improve battlefield and civilian care. Success of the LHP process on the battlefield could mean improved care for civilians. Responsible for more than 160,000 deaths annually, the National Trauma Institute reports that trauma is the leading cause of death in the U.S. for individuals ages one to 44. An LHP product and delivery system that is readily available at the point of care could significantly decrease mortality for these patients. Another advantage of LHP is the ability to reconstitute in less than 2 minutes; where waiting 20 minutes for fresh frozen plasma to thaw – may be the difference between life and death.
“This is a crucial initiative, and HemCon is honored to be the choice of the U.S. Army,” said John W. Morgan, president and CEO of HemCon. “Developing a lyophilized human plasma product and delivery system will be a significant evolution for battlefield and civilian trauma care. It’s also an important evolution for HemCon as we expand our presence in global health care markets. As the use of LHP carries into the civilian medical space, I believe we will see increased survival rates in patients treated at smaller hospitals and numerous trauma centers where currently, fresh frozen plasma is not readily available.”
Source BusinessWire

Who else is interested in Nanotech? ........Hemcon, Alltracel

HemCon's acquisition of Alltracel gives access to Alltracel's joint venture with Elmarco and its proprietary nanotechnology manufacturing process called Nanospider®. HemCon will seek to leverage this process to aggressively grow its market share in acute wound care products developed from chitosan.

Elmarco is a specialist R&D and manufacturing company that has developed, in conjunction with the Technical University of Liberic, a novel proprietary & patented process for spinning polymers into nano-scale fibres for a range of industrial, chemical, micro-electronic and bio-medical applications. This proprietary technology branded Nanospider", represents a major breakthrough in the mass production of nanofibre materials and is now deployed in a number of markets including medical products.
NANOPEUTICS headquartered in Liberic in the Czech Republic and operating internationally has been assigned the relevant woundcare and Nanospider(TM) intellectual property and patents and has already been in advanced discussions including successful product testing with a number of existing consumer and professional woundcare companies.

Entegrion achieve FDA approval

Entegrion, Inc., a privately owned life sciences product development company specializing in technologies for hemorrhage control, resuscitation, and tissue repair, announced that it has received 510(k) market approval from the U. S. Food and Drug Administration (FDA) for its hemostatic medical textile technology. The first application of the technology is Stasilon FR – hemostatic wound dressings for first responders. This market includes EMS workers, police officers, emergency personnel and fire fighters. The Stasilon FR – hemostatic wound dressing was approved by the FDA for use by medical professionals under prescription and “over-the-counter” by consumers to control bleeding resulting from “minor cuts and abrasions” as well as “lacerations, punctures and incisions.” Pending acceptance of an amendment to the FDA approval, a second version of the technology will be implemented as Stasilon OR – hemostatic surgical pads.
Entegrion 510K available HERE

Woundstat

WoundStat was developed in VCU Medical Center's Reanimation Engineering Shock Center, which does research on treating critical illness and injury. Part of the center, Operation Purple Heart, focuses on treating combat casualties.
"We took a step back and examined what the strengths and weaknesses were with the current (blood-stopping) products that were out there to see if there was something we could improve upon," said Dr. Kevin Ward, an emergency physician and the shock center's associate director.
Ward and two colleagues - biochemist Robert Diegelmann and biomedical engineer Gary Bowlin - developed a tan-colored concoction of minerals that looks like a cross between flour, sand and cat litter. After its use, WoundStat can be peeled off the wound.
The researchers were introduced to Jack McDonnell, who licensed the technology and established a company called TraumaCure in May 2006.
McDonnell expects the Food and Drug Administration to approve WoundStat by October, after which TraumaCure will market its product to the military, firefighters and police departments.
Blanck, the retired surgeon general and an outside director of TraumaCure, said current hemorrhage-stopping products - specifically, HemCon and QuikClot - have been a step in the right direction but that there is room for improvement.
"I'm not critical of them because I think they've been responsible for saving lives. Our goal is to save even more," he said.
A spokeswoman for HemCon said its standard-issue bandages work best on large, high-blood flow wounds but are limited on smaller but serious injuries such as a gunshot. QuikClot clots blood but produces a reaction when used that creates excessive heat, and studies have found that it may damage organs and tissues.
An independent study by the Army's Institute of Surgical Research found WoundStat to be a highly effective wound dressing that doesn't produce a heat reaction. The report said the product's primary limitation is that it will stop blood flow on damaged vessels, acting as a granular tourniquet in areas where an actual tourniquet cannot be tied, such as the groin.
Please find the FDA 510K approved 2007 HERE