Director, USAMRAA, 820 Chandler St, Fort Detrick, MD 21702-5014

A -- FY 00 DEPARTMENT OF DEFENSE RESEARCH ON COMBAT CASUALTY CARE RELATED TOPICS SOL CBD-CCC-0426 POC Craig D. Lebo, Contracting Officer, 301-619-2036 The U.S. Army is soliciting proposals for $1.1 million in research on combat casualty care related topics. The Combat Casualty Care Research Program provides integrated capabilities for far-forward medical care to reduce mortality and morbidity associated with major battlefield wounds and injuries. The goals of the research and development effort are to extend the "Golden Hour" for treatment in order to improve survival and minimize morbidity after life-threatening injuries, and to provide military medical capabilities for far-forward medical or surgical care of battle and non-battle injuries. The primary emphasis of the Research Program is the identification and development of medical techniques and materiel (medical devices, drugs, and biologics) for early intervention in life-threatening battle injuries. Battlefield conditions impose severe constraints on available manpower, equipment and medical supplies for casualty care. A premium is placed on medical interventions that can be used within the battle area or as close to it as possible, before or during medical evacuation, preferably by the casualty, other unit members, or medics. Medical materiel must be easily transportable (i.e., small, lightweight, and durable; devices must be easy to use, low maintenance, with self-contained power sources as necessary; drugs and biologics ideally should not require refrigeration or other special handling). Materiel and techniques must be simple and rapid to employ. Identification of techniques and treatments that significantly enhance operational efficiency are also of interest. Topics for Research Proposals ($ budgeted): 1) ($300K) Hemorrhage control studies to include; (a) Studies aimed at the development of a hemostatic agent (e.g. a foam, gel, or other formulation) that may be used under far forward field conditions for controlling hemorrhage that is not compressible, including intra-abdominal and intrathoracic hemorrhage. (b) Studies examining the ability of FDA approved drugs to reduce blood loss following traumatic hemorrhage when administered by an intravascular route. (c) Studies to identify or develop an improved tourniquet for far forward field use. The tourniquet should be applicable one-handed, should have a timer to identify duration of placement, and should have a warning system to alert personnel when it has been dislodged. (d) Studies aimed at the identification or development of devices or systems for warming trauma patients for the prevention or treatment of hypothermic coagulopathy in a far forward field environment. (e) Studies characterizing the coagulopathy of hypothermia in various laboratory species, with emphasis on comparison to humans and development of models for further studies. (f) Studies aimed at the development of new or improved hemostatic agents for use on compressible hemorrhage under far forward field conditions. (g) Experiments to determine how long a tourniquet may be left in place without causing irreversible tissue damage, in the presence or absence of hypotension. (h) Studies aimed at the development of drugs or other methods to induce rewarming in hypothermic patients. (i) Studies aimed at the identification or development of a sensor system for detection of hemorrhage and the characterization of severity of hemorrhage. 2) ($300K) Resuscitation studies to include; (a) Studies to examine the microvascular effects of hypotensive resuscitation to a mean arterial blood pressure (MABP) of 60 mmHg with ringers lactate, 7.5% saline, Hespan, and hypertonic saline/Dextran solutions. (b) Studies to understand the impact of prolonged (4 hours) hypotension (MABP 40 mmHg) occurring as a result of hemorrhage on microvascular hemodynamics and tissue-level oxygen delivery. These studies can be obtained from measurements using such techniques as intravital microscopy, micro-oxygen electrodes, capillary hemoglobin saturation or by phosphorescent decay measurements. Studies should use preparations studying organs other than skin. 3) ($200K) Studies for developing a humane rodent (i.e. rat)model of penetrating traumatic brain injury. The focus of this model is moderate to high velocity missile injury to the brain. The model must recreate all the salient pathologic processes of missile related brain injury. Demonstrated reliability/reproducibility of inter-animal impact kinetics and brain pathology is essential. Emphasis is on minimally invasive, minimally painful humane modeling. Models that employ launched projectiles (e.g., gun, impalers, etc.) will not be acceptable. The successful model will allow neurologic, physiologic, and pathologic assessments relevant and similar to human brain injury. The ultimate goal of this model will be to develop clinically effective treatments for this combat injury. 4) ($100K) Studies to develop and test storage bag(s) to facilitate freeze drying of human blood products. Recent experience with frozen blood products in the field has demonstrated significant loss of blood from storage bag breakage. Alternate storage methods of blood products (e.g. freeze-drying) would eliminate this loss and allow increased availability in remote locations but must not compromise quality, safety, or ease of use. The objective is to freeze-dry blood products (red blood cells, plasma, platelets) within the collection bags. Studies will identify polymers, design, and construct storage bags that will a) not rupture at freeze-drying temperatures, and b) enhance water vapor removal. Storage bags must conform to AABB and FDA standards and regulations. 5) ($200K) Development of a lightweight, mesh and polymer-based splinting system for immobilization of fractures that can be rapidly applied in the field by care providers with little or no orthopedic training. Ideal total weight of a packaged system will not exceed 4 oz. and total set (hydrate) weight will not exceed the weight of current fiberglass casts. Vials of dehydrated polymer catalyst will accompany the polymer and a mesh substrate (e.g. Mylar strips) in a single package. Catalyst will "cure" polymer in 5 minutes. These splints will be cured in all environments except water, but splints and casts will perform well in water when properly "cured." All components of the splinting system will be non-toxic and non-sensitizing to the patient or care provider. The "cured" splints will exhibit strength equivalent to current fiberglass casting materials and will survive for greater than 3 months. The splints can be removed with a standard cast saw, or can be dissolved to biodegradable gel with secondary, polymerlytic catalyst. The U.S. Army Medical Research and Materiel Command (USAMRMC) solicits research proposals on these topics using procedures described in the Broad Agency Announcement (BAA) 99-1 dated December 1998 (available at http://www-usamraa.army.mil). Proposals will be assessed for scientific excellence by extramural peer review. Preproposals are required. Preproposals are due May 26, 2000 by uploading to the website. Please fill in all pertinent blanks on the on-line preproposal submission form. Two or three preproposals will be selected in each of the five topic areas listed above for submission of full proposals. Authors of those preproposals selected will be contacted for submission of full proposals. Complete proposals for studies selected are due no later than 4:00 p.m. August 11, 2000. Contact: Craig D. Lebo, Contracting Officer (301) 619-2036; E-mail craig.lebo@amedd.army.mil Posted 04/26/00 (W-SN448918). (0117)

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