Research Advances In Medical Care For Polytrauma Injuries And Blast Injuries

1. Research Advances In Medical Care For Polytrauma Injuries And Blast Injuries

2. Problems/Threats

3. Causes of Death on the Battlefield

4. OIF and OEFDominant Mechanism of Injury

5. Combat Casualty Care“Big Problems”

6. PHTLS/Tactical Combat Casualty Care

7. Core Skills - Point of Wounding Providers Needle Chest Decompression – SA/BA familiarized, but no needle in IFAK; taught to proficiency for CLS Defibrillation with AED is not taught in the Basic Training CPR course and not taught in CLS, but AED use is “fail-safe” with the new equipment Not a product; however, it is a key component of improved casualty care outcomes. Needle Chest Decompression – SA/BA familiarized, but no needle in IFAK; taught to proficiency for CLS Defibrillation with AED is not taught in the Basic Training CPR course and not taught in CLS, but AED use is “fail-safe” with the new equipment Not a product; however, it is a key component of improved casualty care outcomes.

8. Combat Application Tourniquet® (C-A-T®)

9. Soldier Training/ Improved First Aid Kit (IFAK

10. Joint Theater Trauma System (JTTS) & Joint Theater Trauma Registry (JTTR) Integrated systems approach to Combat Casualty Care Right patient, right place, right time, right care Trauma Registry Real time data, 90 dedicated personnel Data driven method of making changes Better body armor Impact of helicopter evacuation times Employment of Forward Surgical Teams Merge registry with operational data and medical record Training Research The Joint Theater Trauma System (JTTS) is an organized approach to providing improved trauma care across the continuum of the Levels of Care to trauma patients, especially in the battlefield environment. The Joint Theater Trauma Registry (JTTR) is the data repository collecting and hosting all DoD trauma related data. The mission of the JTTS is to: Establish and maintain a Department of Defense Trauma Registry System to capture data and provide information on care and outcomes of military and civilian trauma patients. Provide the Department of Defense and other authorized interests with timely and relevant information about care and outcomes of military and civilian injuries. Create a research strategy that supports reduction of morbidity and mortality in military and civilian trauma patients. Establish and maintain a trauma outcomes database to analyze and evaluate clinical decision making and measure subsequent outcomes for improving treatment modalities. Provide activities of each of the services with full and complete access to data resident in the DoD Trauma Registry. The goals of the JTTS include: Provide the ability to perform data driven battlefield level process improvement of trauma care that drives morbidity and mortality to lowest possible levels. Expand across DoD to bring trauma systems into fixed facility care as well as theater care thus enhancing readiness to provide optimal trauma care to deployed Service members. Emphasize continuous improvement in medical record documentation quality. Capture and share patient data across all levels of care to enable evaluation and adherence to theater clinical practice guidelines and standard operating procedures (SOPs). Identify training requirements, capture injury epidemiology, support research initiatives, and assess success of interventions and outcomes. The Joint Theater Trauma System (JTTS) is an organized approach to providing improved trauma care across the continuum of the Levels of Care to trauma patients, especially in the battlefield environment. The Joint Theater Trauma Registry (JTTR) is the data repository collecting and hosting all DoD trauma related data. The mission of the JTTS is to:

11. Joint Theater Trauma System World Wide Telecommunications: Weekly f/u conf call with Level II+, III, IV, V and VA share lessons learned Weekly Trauma Nurse Coordinators call, including all theater and LRMC/CONUS Monthly System-wide VTC for system issues Includes VA, JPMRC, GPMRC, AMC, CENTAF, CENTCOM Bi-monthly JTTS Directors conference call Committee on Tactical Combat Casualty Care Joint Forces Combat Surgical Training War Surgery Manual Clinical Practice Guidelines Surgeon General Policies Integrate clinical guidelines from the war into mandatory training

12. Clinical Practice Guidelines Reviewed 1 Acoustic Trauma and Hearing Loss February 16, 2010 2 Amputation February 16, 2010 3 Blunt Abdominal Trauma June 30, 2009 4 Burn Care December 20, 2009 5 Catastrophic Care February 16, 2010 6 Cervical Spine Evaluation June 30, 2010 7 Compartment Syndrome (CS) and the Role of Fasciotomy in Extremity War Wounds April 30, 2009 8 Damage Control Resuscitation at Level IIb/III Treatment Facilities February 13, 2009 9 Emergent Resuscitative Thoracotomy May 6, 2009 10 Fresh Whole Blood (FWB) Transfusion January 12, 2009 11 Frozen and Deglycerolized Red Blood Cells (RBCs) June 30, 2010 12 Hypothermia Prevention, Monitoring, and Management June 30, 2010 13 Infection Control February 16, 2010 14 Inhalation Injury and Toxic Industrial Chemical Exposure November 7, 2008 15 Initial Care of Ocular and Adnexal Injuries February 16, 2010 16 Intratheater Transfer and Transport of Level II and III Critical Care Trauma Patients November 19, 2008 17 Management of Patients with Severe Head Trauma November 23, 2010 18 Management of Patients with Severe Head Trauma June 30, 2010 19 Management of War Wounds February 16, 2010 20 Nutrition February 16, 2010 21 Pelvic Fracture Care June 30, 2010 22 Post-Splenectomy Vaccination June 30, 2010 23 Prevention of Deep Venous Thrombosis (DVT) November 21, 2008 24 Spine Injury Surgical Management and Transport July 9, 2010 25 Trauma Airway Management June 30, 2010 26 Urologic Trauma Management June 30, 2010 27 Use of Electronic Clinical Documentation in the CENTCOM AOR June 30, 2010 28 Use of Trauma Flow Sheets December 1, 2008 29 Ventilator Associated Pneumonia - February 16, 2010 30 Vascular Injury November 7, 2008 Source: http://www.usaisr.amedd.army.mil/cpgs.html

13. The U.S. Army Health Facility Planning Agency is located in Falls Church, Virginia (Skyline complex). This organization is the only group within the Army responsible for planning, programming, design, construction, and transition of medical facilities. This includes new construction for medical, dental, and research facilities worldwide. To accomplish this, they serve as the consultant and contractor interface with the Army Corps of Engineers. Members of this organization also deploy worldwide as a MEDCOM special medical augmentation response team to provide their expertise as a part of security, stabilization, and reconstruction operations either after disasters or as a part of our nation building process. The U.S. Army Health Facility Planning Agency is located in Falls Church, Virginia (Skyline complex). This organization is the only group within the Army responsible for planning, programming, design, construction, and transition of medical facilities. This includes new construction for medical, dental, and research facilities worldwide. To accomplish this, they serve as the consultant and contractor interface with the Army Corps of Engineers. Members of this organization also deploy worldwide as a MEDCOM special medical augmentation response team to provide their expertise as a part of security, stabilization, and reconstruction operations either after disasters or as a part of our nation building process.

14. Hypothermia Impact

15. Acidosis Effect Activity of the tissue factor/factor VIIa complex decreases 55% and prothrombinase complex declines by 70% as pH declines from 7.4 to 7.030 Plasma clotting times prolong as pH is reduced

16. Coagulopathy of Trauma Syndrome of non-surgical bleeding from mucosal lesions, serosal surfaces, wound and vascular access sites associated with serious injury INR > 1.5 (reliably predicts those casualties who will require massive transfusion) Seen in most severely injured upon admission to ED Coagulopathy correlated with ISS Also associated with: Hypothermia (temp < 35oC) Acidosis (pH < 7.2 or BD > 6) Hemodilution “Trauma-induced coagulopathy can develop in 24.4% of patients independent of acidosis and hypothermia but secondary to trauma by itself” – J Trauma, Aug 08, p272

22. Early Detection of Significant Blood Loss

23. Medical Care During Transport

25. Post 9/11 Fielded ProductsHemostasis

26. Post 9/11 Fielded Products The Medical Command has achieved an extraordinary level of success in the development and fielding of medical materiel to protect and sustain America’s fighting force. This work includes equipment for the diagnosis, treatment, and evacuation of combat casualties and the development of prophylactic and therapeutic drugs and vaccines to protect and treat U.S. Warriors against infectious diseases or chemical/biological warfare threats. In addition to leveraging proven civilian technologies into military applications, we have been able to achieve success through partnerships with industry, academia, and other government agencies. The Medical Command has achieved an extraordinary level of success in the development and fielding of medical materiel to protect and sustain America’s fighting force. This work includes equipment for the diagnosis, treatment, and evacuation of combat casualties and the development of prophylactic and therapeutic drugs and vaccines to protect and treat U.S. Warriors against infectious diseases or chemical/biological warfare threats. In addition to leveraging proven civilian technologies into military applications, we have been able to achieve success through partnerships with industry, academia, and other government agencies.

27. Combat Lifesaver (CLS) Bag All Soldiers now trained as Combat Lifesavers during Basic Training Basic casualty evaluation Airway management Chest injury and tension pneumothorax mgmt Control bleeding Request medical evacuation All Soldiers now trained as Combat Lifesavers during Basic Training Basic casualty evaluation Airway management Chest injury and tension pneumothorax mgmt Control bleeding Request medical evacuation

28. The U.S. Army Health Facility Planning Agency is located in Falls Church, Virginia (Skyline complex). This organization is the only group within the Army responsible for planning, programming, design, construction, and transition of medical facilities. This includes new construction for medical, dental, and research facilities worldwide. To accomplish this, they serve as the consultant and contractor interface with the Army Corps of Engineers. Members of this organization also deploy worldwide as a MEDCOM special medical augmentation response team to provide their expertise as a part of security, stabilization, and reconstruction operations either after disasters or as a part of our nation building process. The U.S. Army Health Facility Planning Agency is located in Falls Church, Virginia (Skyline complex). This organization is the only group within the Army responsible for planning, programming, design, construction, and transition of medical facilities. This includes new construction for medical, dental, and research facilities worldwide. To accomplish this, they serve as the consultant and contractor interface with the Army Corps of Engineers. Members of this organization also deploy worldwide as a MEDCOM special medical augmentation response team to provide their expertise as a part of security, stabilization, and reconstruction operations either after disasters or as a part of our nation building process.

29. The U.S. Army Health Facility Planning Agency is located in Falls Church, Virginia (Skyline complex). This organization is the only group within the Army responsible for planning, programming, design, construction, and transition of medical facilities. This includes new construction for medical, dental, and research facilities worldwide. To accomplish this, they serve as the consultant and contractor interface with the Army Corps of Engineers. Members of this organization also deploy worldwide as a MEDCOM special medical augmentation response team to provide their expertise as a part of security, stabilization, and reconstruction operations either after disasters or as a part of our nation building process. The U.S. Army Health Facility Planning Agency is located in Falls Church, Virginia (Skyline complex). This organization is the only group within the Army responsible for planning, programming, design, construction, and transition of medical facilities. This includes new construction for medical, dental, and research facilities worldwide. To accomplish this, they serve as the consultant and contractor interface with the Army Corps of Engineers. Members of this organization also deploy worldwide as a MEDCOM special medical augmentation response team to provide their expertise as a part of security, stabilization, and reconstruction operations either after disasters or as a part of our nation building process.

30. EXTREMITY INJURIES 1,566 soldiers sustained 6,609 combat wounds 4.2 wounds per soldier 3,575 extremity wounds 82% of soldiers with at least one extremity wound 2.3 Extremity injuries/wounded soldier 1.3 OMF injuries/wounded soldier Slide 30 of 39

31. EXTREMITY INJURIES Slide 31 of 39

32. Armed Forces Institute of Regenerative Medicine (AFIRM) Goal: To Heal our Wounded Warriors Slide 32 of 39

33. Continuum of TBI Care Determines Research Approach DHA = docosahexaenoic acid (DHA) for neuroprotection against negative consequences of blast exposures and improved recovery following blast exposure and/or traumatic brain injury HMSS = Helmet Mounted Sensor System EYE-TRAC = Ruggedized eye-tracking device, EYE-TRAC, which has been proven to rapidly and accurately detect attention and memory deficiencies in civilian mild TBI BANDITS = Biomarker Assessment for Neurotrauma Diagnosis & Improved Triage System = blood test for brain cell damage, much like the current blood test for heart damage NCAT = Neurocognitive Assessment Tool = fieldable cognitive assessment tool for detecting cognitive disruptions and aiding mTBI screening/assessment NNZ-2566 = drug to treat TBI - a portion of the naturally occurring hormone, Insulin-like Growth Factor, has demonstrated a remarkable ability to reduce non-convulsive seizures in animal studies with TBI. Phase I safety studies have shown an excellent safety profile. HBO2 = hyperbaric oxygen therapy = Intervention in which a patient breathes 100% oxygen intermittently inside a chamber that is pressurized to higher than sea level pressure SCORE = Study of Cognitive Rehabilitation Effects = A randomized treatment trial in a military population with mild traumatic brain injury incurred during deployment to OIF/OEF RTD = return to duty standards = Develop objective repeatable assessments to aid RTD decisions following mTBI DHA = docosahexaenoic acid (DHA) for neuroprotection against negative consequences of blast exposures and improved recovery following blast exposure and/or traumatic brain injury HMSS = Helmet Mounted Sensor System EYE-TRAC = Ruggedized eye-tracking device, EYE-TRAC, which has been proven to rapidly and accurately detect attention and memory deficiencies in civilian mild TBI BANDITS = Biomarker Assessment for Neurotrauma Diagnosis & Improved Triage System = blood test for brain cell damage, much like the current blood test for heart damage NCAT = Neurocognitive Assessment Tool = fieldable cognitive assessment tool for detecting cognitive disruptions and aiding mTBI screening/assessment NNZ-2566 = drug to treat TBI - a portion of the naturally occurring hormone, Insulin-like Growth Factor, has demonstrated a remarkable ability to reduce non-convulsive seizures in animal studies with TBI. Phase I safety studies have shown an excellent safety profile. HBO2 = hyperbaric oxygen therapy = Intervention in which a patient breathes 100% oxygen intermittently inside a chamber that is pressurized to higher than sea level pressure SCORE = Study of Cognitive Rehabilitation Effects = A randomized treatment trial in a military population with mild traumatic brain injury incurred during deployment to OIF/OEF RTD = return to duty standards = Develop objective repeatable assessments to aid RTD decisions following mTBI

35. 2. TBI / Concussion Prevention and Protection Two other preclinical studies are looking at prophylactic neuroprotection with nutraceuticals, though these are very early in development: Angus Scrimgeour USARIEM $206K Core: Preclinical proposal tests whether the micronutrient zinc, with proven efficacy in both rat (Yeiser 2002) and human (Young 1996) TBI studies, will also be efficacious in milder forms of TBI, or concussion. Goal is to develop a ration component that is easily administered by consumption under battlefield conditions. We will test this formulation in an animal model of mTBI that produces a controlled cortical injury to the frontal cortex in adult male laboratory rats. All treated animals will be compared to appropriate controls, based on morphological and functional outcomes that are used routinely in TBI research. Detlev Boison, Legacy Emanuel Hospital and Health Center $300K TATRC: Proposal will address two specific aims: In Specific Aim 1 (phase 1) study prophylactic effects of caffeine exposure prior to TBI. Specific Aim 2 (phase 2) will evaluate the therapeutic benefit of post-injury caffeine treatment. Mild, moderate, and severe TBI will be modeled in the rat lateral fluid percussion injury (FPI) model. First, to replicate typical caffeine use prior to injury in Soldiers, we will assess the influence of acute and chronic caffeine pre-treatment on mortality and morbidity following FPI.Two other preclinical studies are looking at prophylactic neuroprotection with nutraceuticals, though these are very early in development: Angus Scrimgeour USARIEM $206K Core: Preclinical proposal tests whether the micronutrient zinc, with proven efficacy in both rat (Yeiser 2002) and human (Young 1996) TBI studies, will also be efficacious in milder forms of TBI, or concussion. Goal is to develop a ration component that is easily administered by consumption under battlefield conditions. We will test this formulation in an animal model of mTBI that produces a controlled cortical injury to the frontal cortex in adult male laboratory rats. All treated animals will be compared to appropriate controls, based on morphological and functional outcomes that are used routinely in TBI research. Detlev Boison, Legacy Emanuel Hospital and Health Center $300K TATRC: Proposal will address two specific aims: In Specific Aim 1 (phase 1) study prophylactic effects of caffeine exposure prior to TBI. Specific Aim 2 (phase 2) will evaluate the therapeutic benefit of post-injury caffeine treatment. Mild, moderate, and severe TBI will be modeled in the rat lateral fluid percussion injury (FPI) model. First, to replicate typical caffeine use prior to injury in Soldiers, we will assess the influence of acute and chronic caffeine pre-treatment on mortality and morbidity following FPI.

36. Army and Marine Corps fielded nearly 9,000 HMSS to deploying Soldiers and Marines Two versions fielded: Internal and External HMSS: Recorded helmet acceleration & pressure from impacts/explosions An exposure monitor, not a diagnostic tool Value of HMSS: Monitor/document head impact exposures Provide data for development of an objective head injury screening tool Provide data for Next Generation Combat Helmet 3. Objective Measure of Head Impact/ Blast Exposure GEN I HMSS performance problems, poor unit compliance with data downloading requirements, and data handling problems made it impossible to draw meaningful conclusions about the correlation of HMSS data with injuries   However,   HMSS fielding was the critical first step in the development of an objective head exposure monitor and rapid head injury screening tool   Demonstrated the ability to link sensor, operational, and injury data using established Joint Trauma Analysis and Prevention of Injury in Combat (JTAPIC) processes   Demonstrated the ability to translate helmet sensor data into meaningful head “doses” using a mathematical model (leveraged Navy- and National Highway Traffic Safety Administration-funded model development)   Valuable lessons learned are shaping the fielding of GEN II HMSS GEN I HMSS performance problems, poor unit compliance with data downloading requirements, and data handling problems made it impossible to draw meaningful conclusions about the correlation of HMSS data with injuries   However,   HMSS fielding was the critical first step in the development of an objective head exposure monitor and rapid head injury screening tool   Demonstrated the ability to link sensor, operational, and injury data using established Joint Trauma Analysis and Prevention of Injury in Combat (JTAPIC) processes   Demonstrated the ability to translate helmet sensor data into meaningful head “doses” using a mathematical model (leveraged Navy- and National Highway Traffic Safety Administration-funded model development)   Valuable lessons learned are shaping the fielding of GEN II HMSS

37. 4. Head Injury Screening Diffuse axonal injury has been shown to result in deficits associated with concentration, attention, memory, and high-level functions such as planning and decision making. Deficits in visual tracking performance is one manifestation of the effect of diffuse axonal injury. This system can measure the movement of the eye as the subject tracks and predicts the movement of an object. These patterns of ocular tracking are significantly different in TBI patients from medications, sleep deprivation, normal or deliberate attempts to “fake” the results.Diffuse axonal injury has been shown to result in deficits associated with concentration, attention, memory, and high-level functions such as planning and decision making. Deficits in visual tracking performance is one manifestation of the effect of diffuse axonal injury. This system can measure the movement of the eye as the subject tracks and predicts the movement of an object. These patterns of ocular tracking are significantly different in TBI patients from medications, sleep deprivation, normal or deliberate attempts to “fake” the results.

38. 4. Head Injury Screening

39. 5. Head Injury Assessment Biomarker Assessment for Neurotrauma Diagnosis and Triage System The goal of this program is to have an objective measure of cellular damage that, together with other diagnostic information, will help guide the medical management of individuals who suffer a head injury. Researchers at WRAIR, in collaboration with neuroscientists at the University of Florida, have shown that the unique proteins in a nerve cell are spilled into the Cerebrospinal fluid when a brain cell is damaged. Some of these proteins can be measured in the blood if the test is sensitive enough. Preliminary clinical trials are showing very promising results that specific biomarkers have the required sensitivity and specificity to be clinically useful. Large scale clinical trials are planned that will hopefully lead to FDA clearance of this diagnostic test. The most mature platform to implement this test is a benchtop system, which would be feasible in a fixed medical facility. The most optimistic timeframe to FDA approval if the clinical trials continue to show positive results is 3 years from now. Milder forms of TBI are more difficult to differentiate and thus will require larger clinical trials that will take somewhat longer. Smaller devices will take more development but are more appropriate for further forward on the battlefield. Biomarker Assessment for Neurotrauma Diagnosis and Triage System The goal of this program is to have an objective measure of cellular damage that, together with other diagnostic information, will help guide the medical management of individuals who suffer a head injury. Researchers at WRAIR, in collaboration with neuroscientists at the University of Florida, have shown that the unique proteins in a nerve cell are spilled into the Cerebrospinal fluid when a brain cell is damaged. Some of these proteins can be measured in the blood if the test is sensitive enough. Preliminary clinical trials are showing very promising results that specific biomarkers have the required sensitivity and specificity to be clinically useful. Large scale clinical trials are planned that will hopefully lead to FDA clearance of this diagnostic test. The most mature platform to implement this test is a benchtop system, which would be feasible in a fixed medical facility. The most optimistic timeframe to FDA approval if the clinical trials continue to show positive results is 3 years from now. Milder forms of TBI are more difficult to differentiate and thus will require larger clinical trials that will take somewhat longer. Smaller devices will take more development but are more appropriate for further forward on the battlefield.

40. BANDITS PROGRAMBiomarkers in Severe TBI Patients

41. BANDITS PROGRAM Biomarkers in Mild TBI Patients

42. 6. TBI / Concussion Treatment No drug currently is approved to treat TBI in humans. Researchers at WRAIR, in collaboration with New Zealand researchers, have discovered a molecule (NNZ-2566, an analog of glypromate) that is part of a naturally occurring hormone (IGF-1) in the brain. In animal models, this molecule appears to reduce the effects of a brain injury. This molecule has been well tolerated in initial safety trials and further clinical trials are currently in progress in civilianTBI patients. The FDA has agreed to an expedited approval process if studies show the positive benefit in humans that was seen in preclinical studies. However, it may take up to 5 years to complete the studies that would lead to that approval.No drug currently is approved to treat TBI in humans. Researchers at WRAIR, in collaboration with New Zealand researchers, have discovered a molecule (NNZ-2566, an analog of glypromate) that is part of a naturally occurring hormone (IGF-1) in the brain. In animal models, this molecule appears to reduce the effects of a brain injury. This molecule has been well tolerated in initial safety trials and further clinical trials are currently in progress in civilianTBI patients. The FDA has agreed to an expedited approval process if studies show the positive benefit in humans that was seen in preclinical studies. However, it may take up to 5 years to complete the studies that would lead to that approval.

45. Summary/Conclusion 45