Archive for the ‘Research’ Category

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.

En Route Care and Training for Immediate Responders Explored in November JOT Supplement Covering 2015 MHSRS Proceedings

Thursday, November 10th, 2016

Supplement 1 of the Journal of Trauma, Volume 81, No.5, carries multiple papers emanating from the 2015 Military Health System Research Symposium. Below are synopses of several. To read the entire supplement, click here.

Machine learning and new vital signs monitoring in civilian en route care: A systematic review of the literature and future implications for the military  

Researchers Nehmiah Liu and Jose Salinas, PhD, reviewed the existing literature related to machine learning (ML) algorithms (MLA) and new vital signs monitoring (NVSM) in civilian en route care in order to determine their potential to fill combat medicine capability gaps. Recent machine learning technologies include those that monitor novel vital signs such as heart rate variability (HRV) and heart rate complexity (HRC). In addition, the photopletysmograph wave form and data quality indices offer potential ways to evaluate the need for lifesaving interventions during en route care.

There continues to be limited means of monitoring and recording data in-flight–such as vital signs, waveforms or interventions made by in-flight personnel—and an imperative to leverage such data to improve care and reduce mortality. Thus, the researchers are optimistic that new innovations could be of benefit in combat scenarios, but caution that further validation is warranted before widespread use. “Almost all studies required further validation in prospective and/or randomized controlled trials,” they determined.

 

Combat MEDEVAC: A comparison of care by provider type for en route trauma care in theater and 30-day patient outcomes

A 2009 change in military combat medicine policy led to the integration of Air Force Pararescuemen with paramedic training into MEDEVAC missions in a bid to decrease mortality. Paramedic level training was thus incorporated into the initial flight medic training of DUSTOFF medics in 2012, and a new program course at Fort Sam Houston provided additional paramedic and critical care training to promote all skill competencies at the EMT–intermediate/paramedic level as well as CCFP certification.

Vikhyat Bebarta, MD, and other researchers at Fort Sam Houston sought to analyze the resulting reallocation of resources in order to determine whether the intended benefit had been attained. In this study, the researchers identified and described medical providers and their specific roles on MEDEVAC missions, and identified associations between provider type, procedures performed, medications administered, survival, and 30-day outcomes.

In a review of more than 1,200 records of US casualties between 2011 and 2014, they determined that 76% of MEDEVAC personnel were medics, 21% paramedics, and 4% were advanced-level providers (ADVs) including nurses, physicians, and physician assistants. Providers with higher-level training were more likely to perform more advanced procedures during en route care; however, there was no significant association between provider type and in-theater or 30-day mortality rates. “More evidence is needed to determine the appropriate level of MEDEVAC personnel training and skill maintenance necessary to minimize combat mortality,” the researchers concluded.

Liu and Salinas argue for research that advances these technologies for en route care. “Importantly, these innovations could not only enhance trauma casualty care for our nation’s war fighters in a complex global environment but also close gaps–specifically, monitoring and the early detection and treatment of various injuries,” say the researchers.

 

Improving national preparedness for mass casualty events: A seamless system of evidence-based care

Researchers Alexander Eastman, MD, William Fabbri, MD, Kathryn Brinsfield, MD, and Lenworth Jacobs, MD, argue in a special report that the U.S. lacks “a unified, coordinated national system to respond to intentional mass casualty attacks….”

The researchers note that our national preparedness goal is thwarted by segmented, compartmentalized, or simply unobtainable investigative, clinical, and medical examiner data following mass casualty events. The distributed nature of the ownership of various segments of the civilian health care system is to blame, they say, and the consequence is that “conjecture, bias, and anecdote inform the civilian section of our national response rather than scientific evidence.”

The Hartford Consensus, they contend, is one attempt to evaluate evidence-based approaches to the problem. The authors review recommendations from successive Hartford Consensus meetings and conclude that immediate responders to mass casualty events, employing bleeding control techniques, hold the key to national resilience. Immediate responders, as defined, include law enforcement officers, bystanders, and even victims.

“Our military colleagues have demonstrated that a robust data collection system, organized scientific study of the problem, and system-wide implementation of evidence-based solutions can significantly improve survival from intentional traumatic injury,” Eastman et al. conclude. “Our duty now is to build the foundations of an analogous civilian system in order to begin to answer the remaining questions and to truly improve our national preparedness.”

NIH For Trauma Necessary to Support Civilian Acute Care Needs

Thursday, October 20th, 2016

In an article published in The New England Journal of Medicine, Todd Rasmussen, MD (DoD Combat Casualty Research Program) and Arthur Kellerman, MD (Uniformed Services University of the Health Sciences) propose the establishment of an NIH institute dedicated to trauma and emergency care research.

DoD funding represents more than 80 percent of the federal government’s annual investment in trauma care research, the authors point out. “Although this arrangement ensures the military relevance of federal research on trauma care, it provides little support for civilian priorities and leaves the field overly dependent on DoD funding.”

Rasmussen and Kellerman reference the June 2016 report from the National Academies of Science, Engineering and Medicine, which calls for a National Trauma Action Plan that integrates civilian and military trauma care capabilities. Establishing an NIH for trauma, they contend, will help to “drive the number of preventable deaths after injury down to zero.”

Read the article.

NTI Shares Lessons Learned Over a Decade of Study Management

Thursday, September 8th, 2016

Just published in the Journal of Trauma and Acute Care Surgery (Vol 81, No 3), “The National Trauma Institute: Lessons learned in the funding and conduct of sixteen trauma research studies” analyzes and discusses how funded researchers approached obtaining regulatory approval, enrolling patients, navigating the Exception from Informed Consent process, coordinating multiple study sites and more.

The article offers some solutions for reducing challenges and lag times inherent in the study completion timeline. Among the insights, 40 percent of the funded investigators reported delays in obtaining regulatory approval at one or more institutional levels, which had serious impacts on study management. “The time required to obtain approvals delayed the funding awards considerably and resulted in the loss of study sites, turnover in research trainees, and the need to use alternate sources of funds for research staff salaries, protocol review, and community consultation costs,” NTI found.

NTI’s insights about navigating the regulatory environment square with the findings of the National Academies of Sciences, Engineering and Medicine (NASEM) in its June 2016 report: A National Trauma Care System: Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury. “To accelerate progress toward the aim of zero preventable deaths after injury and minimizing disability, regulatory agencies should revise research regulations and reduce misinterpretation of the regulations through policy statements” is one of the recommendations of the NASEM Committee on Military Trauma Care’s Learning Health System and Its Translation to the Civilian Sector. [Read a summary of the NASEM report HERE].

In all, NTI reports lessons that are instructive for trauma researchers in four key areas: regulatory processes, multisite coordination, adequate funding, and research infrastructure.

Research Sponsored by NTI Yields Insights on VTE

Tuesday, September 6th, 2016

This month, Martin A. Schreiber, MD, and his team published an article in JAMA Surgery online, following the completion of a study funded by the Department of Defense through the National Trauma Institute (NTI). The randomized clinical study compared patient outcomes for those administered standard vs. TEG-adjusted prophylactic enoxaparin dosing.  The researchers found that the time to enoxaparin initiation was more rapid than prior studies and the incidence of VTE was low and similar in both groups.

The data suggest that a difference in reaction time of more than 1 minute to initial fibrin formation comparing standard kaolin and heparinase TEGs may be associated with a decreased risk of venous thromboembolism (VTE); however, the study population may have been too limited to reveal significant results. “Low VTE incidence may be due to an early time to enoxaparin initiation and an overall healthier and less severely injured study population than previously reported,” note the researchers. Of the 185 trial participants, only 22 achieved a difference in reaction time greater than 1 minute despite increased enoxaparin dosing in the treatment group.

Risk factors for VTE were identified as older age, higher body mass index, increased Acute Physiology and Chronic Health Evaluation II score and more missed doses per patient.

As VTE is a major cause of potentially preventable death in trauma patients, related studies are important. One recommendation arising from this work is to improve compliance with dosing protocols (almost all the subjects missed at least one dose). Because the results were inconclusive, follow-on research focusing on patients with more severe injuries and prolonged hospital stays—during which there would be additional follow-up over time—is recommended. “These data demonstrate that many trauma and surgical patients are hypercoagulable at baseline and that further investigations into the effects of platelet activation, obesity, time to enoxaparin administration, and AT-III deficiency are needed.”

CNTR’s First DoD Research Proposal to be Funded

Tuesday, August 16th, 2016

With a recently announced $4 million Department of Defense grant, the Coalition for National Trauma Research (CNTR) begins an intensive investigation into the causes and mechanisms of U.S. deaths that occur outside of hospital settings. NTI is a coalition member.

The project, officially called Multi-Institutional Multidisciplinary Injury Mortality Investigation in the Civilian Pre-Hospital Environment (MIMIC), aims to evaluate the causes and pathophysiologic mechanisms of pre-hospital deaths in order to determine survivability by mechanism of injury and the appropriateness of EMS response and the care delivered.

Brian J. Eastridge, MD, Clinical Professor of Surgery at the UT Health Science Center at San Antonio and a Colonel in the U.S. Army, is the principal investigator for the MIMIC project. During his active duty service, Dr. Eastridge was the Trauma Consultant to the U.S. Army Surgeon General and co-developer and Director of the Joint Trauma System. His work analyzing causes of combat death, published in the Journal of Trauma and Acute Care Surgery in 2012, determined that 25 percent of those casualties had injuries that were potentially survivable. The MIMIC grant enables a comparable analysis of civilian death.

In partnership with the National Association of Medical Examiners, MIMIC will engage 60-75 clinician/reviewers to form study panels that will review 3,000 pre-hospital deaths in six diverse states and regions across the country. CNTR will also partner with the Johns Hopkins Bloomberg School of Public Health, whose Data Coordinating Center will be employed for data analysis.

The Coalition for National Trauma Research (CNTR) includes the country’s five leading trauma organizations: American Association for the Surgery of Trauma, National Trauma Institute, Eastern Association for the Surgery of Trauma, ACS Committee on Trauma and the Western Trauma Association. As CNTR, these organizations seek consistent and significant federal funding for trauma research, build trauma research infrastructure and advocate for a centralized research agenda to prioritize work in the discipline. Visit CoalitionNTR.org for more information.

Defense Health and Research Programs Support Troop Readiness, Leaders Testify

Tuesday, March 22nd, 2016

Today, leaders of Department of Defense health programs testified at a hearing held by the House Defense Appropriations Subcommittee. Speaking on behalf of their programs were Vice Admiral Raquel Bono, Director of the Defense Health Agency; Lt Gen. Nadja West, Surgeon General of the U.S. Army; Vice Admiral Clinton Faison, III, Surgeon General of the U.S. Navy; and Lt Gen. Mark Ediger, Surgeon General of the U.S. Air Force.

In his opening statement, Subcommittee Chairman Rodney Frelinghuysen praised remarkable improvements in combat injury survivability and recognized the importance of DoD research and development of innovative treatments and devices within the Congressionally Directed Medical Research Program. Investments in the program have made it possible for gravely wounded troops to survive and thrive, he noted.

Each DoD leader focused attention on the programs and facilities within his or her jurisdiction and gave examples of taxpayer spending that returns enormous benefits to our service men and women and their families. The trauma resources at Bagram Air Base in Afghanistan; research consortia in orthopedic trauma, spinal cord injury, TBI and regenerative medicine; and the trauma system that includes highly trained medical personnel, battlefield units, evacuation systems and rehabilitation facilities were all touted as investments in the readiness of the U.S. fighting force that cannot be overvalued.

In responding to a question from Ranking Member Peter Visclosky regarding whether there were any gaps that were cause for concern, Lt Gen. Ediger made that point that the care provided to U.S. combat troops is more complex than ever before, and deployable medical teams must be ready to deliver that complex care at any given moment. Maintaining their skills and training, he said, is key to maintaining the readiness of the troops.

View the entire hearing.

 

Female Sex Hormone May Increase Survival Time Following Massive Blood Loss

Thursday, October 22nd, 2015

After years of research showing promise that a female sex hormone may prolong survival despite massive loss of blood, University of Alabama at Birmingham researchers received funding from the Combat Casualty Care Research Program, US Army Medical Research and Materiel Command, to conduct human trials.

Irshad Chaudry, Ph.D, and colleagues at UAB discovered, after accidentally receiving female rats for study, that “a dose of the estrogen 17β-estradiol (E2) could protect males and females against septicemia…The estrogen affects the immune system and cardiovascular responses, which typically are profoundly depressed after trauma.”

In follow-on studies, Chaudry and his colleagues found that E2 could allow survival for three hours without any fluid resuscitation, and long-term survival if fluid resuscitation was provided after three hours.

Chaudry’s 19-year study of the effect of estrogen began at the Shock and Trauma laboratories, Michigan State University, and at the Center for Surgical Research at Brown University School of Medicine. Chaudry moved to UAB in 2000.

Read More

 

Cutting Transport Time and Enhancing Pre-Hospital Care Saved Hundreds

Monday, October 5th, 2015

Sept 30, 2015 JAMA articleIn the September 30, 2015 online edition of JAMA Surgery, Russ S. Kotwal, MD, et al. review the effect of a 2009 policy change on the morbidity and mortality of combat casualties in the wars in Iraq and Afghanistan. Then Secretary of Defense, Robert Gates, issued a mandate to reduce transport time from battlefield to hospital care to 60 minutes—the so called “golden hour.”

According to the researchers, transport time was reduced by 52% to a mean of 73 minutes, and the study “…showed a significant survival benefit after the mandate, specifically as a result of a reduction in KIA [killed in action] mortality.” This decrease persisted despite an increase in the severity of injuries being treated as method of injury shifted from gunshots to explosions as the wars progressed.

Despite acknowledged limitations of the study, the authors note, “the data show that…shorter transport times and enhancements to treatment capability…improved outcomes and potentially saved 359 lives.”

In his invited commentary on the study, “The Power of Advanced Capability and Informed Policy,” Col Todd E. Rasmussen, MD, Director of the US Combat Casualty Care Research Program, notes that reduction in the KIA percentage following the policy change provides evidence of an enhanced capability during the golden hour after injury that includes enhanced point of injury care and en route platforms, in addition to the reduction in transport time.

Rasmussen cautions against a “mission-complete” reaction, however, suggesting that future casualty care scenarios may be more complex and that military and civilian planners should “learn from the whole of the effort…and develop better ways to build trauma care capability and inform policy for future, more complex casualty scenarios.”

Read the article and commentary

 

CDC Reports that Injury Cost the U.S. $671 Billion in 2013

Wednesday, September 30th, 2015

In its latest Morbidity and Mortality Weekly Report (October 2), the Centers for Disease Control (CDC) provides new estimates for the annual financial toll of injury in the U.S. Combined medical and work loss costs amount to $671 billion in 2013, the year studied. Fatal injuries were found to contribute $214 billion of that total, and non-fatal injuries, $457 billion.

The data presented in this report indicate significant increases in the cost of both fatal  and nonfatal injury. The increases are related to changes in methodology and in injury trends, including increases in poisoning, suicide and falls.

Among the many findings, the report shows that falls and transportation-related injuries account for the majority of work loss costs associated with non-fatal injuries.

Read the complete report here–click on the Weekly Report link