OpportunityTitle: DoD Combat Casualty Care Prolonged Field Care Research Award
Description: The intent of the PFCRA is to target the emerging need to provide extended trauma care prior to reaching a location that can provide definitive hemorrhage and contamination control. Trauma care during this period is often called &#8220;Prolonged Field Care&#8221; (PFC). Traditionally, improvements to the trauma care system have focused on shortening evacuation times from the point of injury to the first surgical site. However, in future conflicts or mass trauma events, it is anticipated that the initial evacuation time, and thus initial surgical hemorrhage and contamination control, may be delayed for hours or days.This challenge also requires research to develop new solutions to provide for prolonged Damage Control Resuscitation (pDCR) including: support for medical providers in the out-of-hospital setting (point of injury, austere environment, or en route care) with limited resources; understanding the physiologic impact of pDCR; and techniques to mitigate the negative effects of delayed surgical intervention. The research and solutions must be focused on patient-level interventions and outcomes, rather than the broader trauma system. However, proposed research and solutions should consider the entire continuum of trauma care.The JPC-6/CCCRP has identified three overarching Focus Areas for funding under this Program Announcement/Funding Opportunity. To meet the intent of the award mechanism, applications MUST specifically address at least one of the three PFCRA Focus Areas. Research not aligned to at least one of these Focus Areas will not be considered for funding. The FY16 JPC-6/ CCCRP PFCRA Focus Areas are:Focus Area 1: Understand the clinical implications of PFC and pDCR, including:&#8226; Improving the understanding of physiological parameters requiring monitoring and intervention in order to reduce morbidity and mortality during the acute treatment phase (up to 72 hours) of a traumatic brain injury (TBI).&#8226; Characterization and mitigation of the pathophysiology of prolonged hypotension or hypotensive resuscitation (up to 72 hours).&#8226; Characterization of the consequences of prolonged (over 2-4 hours) use of current prehospital hemostatic devices and methods, and/or identifying the limits of use and areas where alternative methods will be required.&#8226; Identify and characterize prolonged field care challenges to providing organ support and critical care interventions.&#8226; Evaluation of the physiologic impact of transportation following PFC and the effect on clinically relevant outcomes..Focus Area 2: Develop next-generation resuscitation and stabilization methods for PFC and pDCR, including:&#8226; Novel or improved methods for resuscitation and stabilization of casualties with combined hemorrhagic shock and acute TBI, with or without other concomitant injuries.&#8226; Point-of-injury/point-of-need/prehospital capabilities to monitor and/or stabilize acute TBI casualties. The goal is to enable earlier detection of life-threatening conditions, improve decision-making timelines, and/or mitigate progression of brain injury in pDCR and/or remote operating environment scenarios.&#8226; Approaches to metabolic and tissue stabilization to enable prolonged out of hospital (prehospital and en route) survivability, and provide organ support and critical care in the prolonged field care environment.&#8226; Novel approaches for improving oxygen delivery to tissues (not via ventilator) under conditions of prolonged hypotension and polytrauma.Focus Area 3: Develop enhanced treatment of injuries during PFC and pDCR, including:&#8226; TBI treatments (including cellular therapies, drugs, or devices) to decrease morbidity and mortality and improve immediate and long-term outcomes.&#8226; Forward surgical techniques, knowledge products, and augmentative technology for surgical stabilization of life- and limb-threatening injuries. The goal is to decrease morbidity and mortality in the out-of-hospital (prehospital and en route) environment scenarios, to include intravascular techniques (such as resuscitative endovascular balloon occlusion of the aorta [REBOA]) and other advanced hemostatic approaches.&#8226; Critical care knowledge, interventions, and simplified portable organ support technology to reduce, reverse, or treat organ failure and perfusion/reperfusion injury due to treatment effects of pDCR and/or remote operating environment scenarios.&#8226; Knowledge and techniques to acutely stabilize and treat tissue injury, to include, but not limited to, burn injury, facial injury, chest wall crush/fractures, pelvic fractures, bony spine injury, extremity fractures, and large soft tissue defects. The goal is to prevent infection, minimize further tissue loss, protect underlying tissues/organs, reduce ischemia and secondary injury, reduce pain and suffering, and provide safe transport in support of pDCR and/or remote operating environment scenarios.For this Program Announcement/Funding Opportunity, a knowledge product is defined as a non-materiel product that addresses an identified need, research area, or capability gap in the continuum of trauma care. Knowledge products provide information, awareness, and procedures to support clinical practice, training recommendations, and the application of existing materiel products (e.g., drugs, medical devices, and equipment).This Program Announcement/Funding Opportunity may support preclinical research, clinical research, and early clinical trials/testing. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for ameasurable outcome with respect to safety, effectiveness, efficacy, and/or exploratory information. This outcome represents a direct effect on the human subject of that intervention or interaction. For further definitions, categories, and resource information for human subject research, see the Human Subject Resource Document available on the eBRAP &#8220;Funding Opportunities &amp; Forms&#8221; web page (https://ebrap.org/eBRAP/public/Program.htm). Phase II and Phase III clinical trials for Food and Drug Administration (FDA) licensure of drugs and definitive/pivotal testing for device clearance by the FDA will NOT be permitted under this Program Announcement/Funding Opportunity.
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