Archive for the ‘New Treatments or Devices’ Category

USAISR Receives FDA Approval for Compensatory Reserve Indicator

Monday, February 6th, 2017

Collaborating with other scientists and engineers, the U.S. Army Institute of Surgical Research developed an algorithm that measures the body’s ability to compensate for blood loss, or the compensatory reserve. The compensatory reserve index (CRI) can predict when a patient is about to go into hemorrhagic shock. The device, which takes readings from a standard pulse oximeter, received FDA clearance in December 2016.

USAISR researchers believe that combat medics attending to battlefield wounded, as well as civilian EMTs, can employ the device to save lives, as it can continuously monitor patients and provide a guide for fluid resuscitation and other interventions.

Read the full story.

Trial of Body Cooling Procedure Concludes–One Step Closer to Saving Lives

Monday, November 21st, 2016

The November 28, 2016 edition of The New Yorker reports that Baltimore’s Shock Trauma recently completed a trial of emergency preservation and resuscitation (EPR), a procedure that may be able to save patients who otherwise would die from exsanguination. It’s a procedure wherein the chest cavity of a bleeding patient is pumped full of ice-cold saline. The procedure drops the patient’s brain temperature into the lower fifties and puts the body into a state of suspended animation for up to an hour while surgeons can repair bullet holes and other injuries.

EPR “has long been proved successful in animal experiments, but overcoming the institutional, logistical, and ethical obstacles to performing it on a human being has taken more than a decade,” reports Nicola Twilley, author of The New Yorker article. Dr. Sam Tisherman directed the EPR trial–he began work related to the procedure while at the University of Pittsburgh. Continuing the work of Dr. Peter Safar, his mentor and one of the founding fathers of resuscitation science, Dr. Tisherman has been joined in his pursuit by many colleagues across the United States throughout the years.

“In the United States, between thirty and forty thousand people a year bleed to death from fixable injuries,” says Twilley. “Ultimately, if the technique does evolve as Tisherman envisages, it will simply become the next step for treatment after CPR has failed, used to buy time and prevent brain death.”

It will likely be two years before the results from the trial can be made public.

Read the full, amazing story about how the research unfolded over three decades to make this procedure possible.

Stop the Bleed Initiative Plugged by CBS’s “Code Black” Cast Members

Tuesday, October 11th, 2016

Stop the Bleed, a nationwide campaign to educate bystanders on how to control bleeding related to traumatic injuries, just released a video featuring actors from “Code Black” in an effort to raise awareness about the campaign. Launched by the White House a year ago, the initiative is similar to longstanding efforts to engage citizens in first aid like administering CPR and using AED machines in emergency situations. By following the protocol, bystanders can act to staunch bleeding while waiting for help to arrive.

“Uncontrolled bleeding injuries can result from natural and manmade disasters and from everyday accidents,” explained the White House when announcing the initiative in October, 2015. “If this bleeding is severe, it can kill within minutes, potentially before trained responders can arrive. Providing bystanders with basic tools and information on the simple steps they can take in an emergency situation to stop life threatening bleeding can save lives.” For more information, visit the Department of Homeland Security: HERE.

Watch the PSA on Youtube: HERE


FDA Clears Military Traumatic Wound Dressing for Civilian Use

Tuesday, December 8th, 2015

XSTAT 30 is an expandable, multi-sponge dressing that has been used on the battlefield to control severe, life-threatening bleeding that is non-compressible (in locations like the torso, groin or armpit where a tourniquet cannot be placed). The FDA’s clearance yesterday expands the device’s indication from use in military settings only to use in adults and adolescents in civilian settings.

“When a product is developed for use in the battlefield, it is generally intended to work in a worst-case scenario where advanced care might not be immediately available,” said William Maisel, M.D., M.P.H., in the FDA’s press release on the clearance. Maisel is acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

XSTAT 30 may now be used in patients at high risk for severe hemorrhagic shock and non-compressible wounds when definitive care at an emergency care facility cannot be achieved within minutes.

Read More.

Nanoparticles Shaped Like Platelets Show Promise in Stopping Bleeding

Monday, November 17th, 2014

Researchers in the Department of Chemical Engineering and Center for Bioengineering (CBE) at UC Santa Barbara have created and are experimenting with nanoparticles that copy the shape, flexibility and surface biology of the body’s own platelets.

These tiny, platelet-shaped particles behave just like their human counterparts and can be added to the  to supply or augment the patient’s own natural platelet supply, stemming the flow of blood and initiating the healing process. Initial experimentation indicates that emergency situations can be brought under control faster, injuries can heal more quickly and patients can recover with fewer complications.

Read more.

3D Bioprinting Shows Promise to Heal Traumatic Wounds

Monday, July 14th, 2014

Investigators within the Armed Forces Institute of Regenerative Medicine, or AFIRM, a consortium of about 30 universities, hospitals and other partners, say that 3D bioprinting technology may one day help the healing of traumatic injuries.

Through 3D bioprinting, cells that can grow new skin may be precisely applied to a wounded area. AFIRM researchers say one day a scientist could use a laser scan to create a map of a badly burned area. A computer program would interpret the map and indicate what types of cells to use where. Fibroblasts for the deeper layer of skin and keratinocytes for the surface layer would then be loaded into the bioprinter, which could place the cells precisely. The skin grown would be complete with sweat glands, hair follicles and proper pigmentation.

AFIRM researchers are also working on vascular printing, which could lead to the creation of muscle tissue, organs and limbs.

Read More.


Suspended Animation Buys Time for Trauma Surgeons

Tuesday, June 24th, 2014

Dr. Samuel Tisherman, a trauma surgeon at Maryland Shock Trauma Center in Baltimore, and colleagues are testing a way to potentially save the lives of patients who have bled so much that their hearts stop.

Officially called “induced hypothermia” or “emergency preservation and resuscitation,” the process involves the insertion of a tube into the aorta and pumping in a large amount of ice-cold saline solution to cool the  body as quickly as possible to about 50 degrees.

Induced hypothermia shuts down the patient’s cell activity and places the person in a sort of temporary limbo — not dead, but not fully alive, either — and buys surgeons up to 45 minutes to get patients into an operating room and begin to repair injuries.

The process has proven successful in animal studies, and clinical trials begin soon at the UPMC Presbyterian Hospital in Pittsburgh, Pennsylvania. Patients to be enrolled in the study will have suffered cardiac arrest after a traumatic injury and have little chance of survival under normal circumstances.

Watch a CNN clip of this story.

Parents Get Help Identifying Traumatic Brain Injury

Wednesday, June 4th, 2014

The Centers for Disease Control today released an app called Heads Up (available on iTunes) that provides information about sports-related concussions, helps people identify the signs and symptoms of a concussion or other serious brain injury and explains what to do if they suspect a child has suffered a concussion.

The app also provides information on selecting protective helmets for different activities.

What a fantastic resource and a great way to raise awareness! We hope every parent whose children are active in sports downloads this app!

Injectable Bandage May Offer Solution to Noncompressible Hemmorhage

Monday, April 14th, 2014

The Combat Casualty Care Research Program (CCCRP) has developed a relatively simple device to deal with a deadly problem: a syringe that injects bandages into deep injuries that cannot be treated with compression or tourniquets. So-called noncompressible hemmorhage is an NTI priority, as it is the primary cause of battlefield death related to potentially survivable injuries.

The device, called XSTAT contains small cellulose sponges that expand inside the wound, applying pressure from the inside to stop the bleeding. XSTAT recently received FDA approval and will be available commercially from manufacturer RevMedx. Read More.

New Cooling Technique May Stem Blood Loss

Monday, April 7th, 2014

According to a story reported in the Daily Beast, the University of Pittsburgh Medical Center will begin human trials using a super cooled electrolyte solution to slow blood loss in trauma patients when they don’t have time to get to a hospital before bleeding to death. Prior animal studies conducted at Massachusetts General Hospital and funded through the  Defense Advanced Research Projects Agency (DARPA), found that 90 percent of animals put into cold suspension could be revived with no loss of cognitive function.

Researchers don’t expect as positive a response in humans, since compounding factors in the study population–such as heart disease or diabetes–were not an issue. However, Sam Tischerman, who is heading the UPMC study, is cautiously optimistic: “Our hope is that we can save some people we can’t right now.”

“Methods to prevent deaths from blood loss are crucial, since about 85 percent of deaths on the battlefield are from bleeds medics can’t compress,” the article confirms. So-called non-compressible hemorrhage is one of the National Trauma Institute’s research priorities, and NTI was referenced in the story. Read the complete article.