RT&L FOCUS AREA(S): General Warfighting Requirements (GWR)
TECHNOLOGY AREA(S): Bio Medical
OBJECTIVE: To develop a container or container system for transporting blood to and throughout the battlefield.
DESCRIPTION: Traumatic hemorrhage remains the leading cause of combat deaths, and rapid resuscitation with blood and/or blood products is necessary to restore volume, maintain hemostasis, and prevent coagulopathy and other morbidities.[1-3] Therefore, blood and blood products must be present at or near the battlefront.[4-7] To facilitate this rapid deployment of blood, inventories must be bolstered through transportation of blood and blood products from donation centers to forward locations. This need is not limited to theaters of war; maintaining blood bank inventories around the globe is critical, but as biologics, these products must be transported with proper cold chain maintenance in containers that can withstand arduous journeys and austere environments and can minimize breakage of storage bags for peak logistical efficiency.[8-11]
There are multiple points of potential failure: for instance, after a donation at a blood drive, blood must be packaged and transported to the blood bank where it is required to be tested, processed, and stored until laboratory results are obtained. Then, the blood must be inventoried, packaged, and sent to distribution. It must be maintained cold during shipment overseas (potentially with multiple stops) before receipt and storage at local facilities. Additionally, it must be maintained cold for in-country ground and air shipping to Role of Care 2 or 3 facilities (see  for descriptions of Army Roles of Care), at which it must be stored until used or until packaged for carrying by a medic prior to a high risk mission (Role of Care 1). At each step, temperature control is critical if blood is to remain in compliance with established standards; very little variance is allowed. Thus, along with the capability of maintaining these temperatures, a careful record demonstrating the unbroken cold chain is required. Development of a standardized low- or no-power advanced transportation container or container system for blood and blood products that will maintain the cold chain with confirmation and minimize breakage and waste is of critical importance. Specific emphasis should be placed on the following parameters: scalability for different Roles of Care, minimizing weight for each step of the transport process; stackability for usage on military aircraft; ruggedness and reusability justified by the relative cost; integrating or easily used temperature monitoring; size appropriate for required capacity (e.g., two 500 ml whole blood units for medic, 20-40 units at Role of Care 2); minimized power requirements; potential for integration into air, sea, and land vehicles including unmanned aerial systems; and cost must be reasonable versus current operational standards.
PHASE I: Phase I will consist of designing schematics and diagrams along with limited testing of technology to be used for a low- or no-power advanced transportation container or container system for blood and blood products, to include techniques for maintaining temperature over lengthy travel times (10+ days), descriptions for monitoring temperature with notification of excursions, and designs for protecting products from breakage. The device will be designed such that usage can be standardized across a variety of environmental factors. Specific emphasis will be placed on weight, stackability, ruggedness, temperature monitoring capability, capacity, power requirements, potential integration into vehicles including unmanned aerial systems, and cost. An argument for the approach chosen will be included.
PHASE II: This phase will consist of further developing the low- or no-power advanced transportation container or container system for blood and blood products, demonstrating its utility, and validating the prototype(s) through relevant testing. During the first year, the prototype(s) should be demonstrated by the proposer in simulated temperature-controlled and vibration stress-controlled environments and/or in transportation to mimic expectations to determine practical viability. The second year will involve refinement and more rigorous testing of the chosen designs in simulated field tests. Testing and refinement will involve the devices’ functionality within battlefield constraints; the devices must be portable, lightweight if intended for medic kit, stackable if intended for shipping, self-contained, have low or no power requirements, compatible with vehicles including unmanned aerial systems, and have planned production costs that are justifiable against current standards. The phase II commercialization plans should include a regulatory plan for FDA clearance if required.
PHASE III DUAL USE APPLICATIONS: The technology developed under this SBIR effort will have applicability to both civilian and military emergency medicine. Phase III will consist of finalizing the device design(s) and delivering manufactured devices (in their final form) for military-relevant testing (e.g. environmental, operational, etc.) and FDA-related testing (e.g. blood impact, validation, etc.). The device will be functional for use by blood bank personnel, logisticians, medics, physician assistants, nurses, and physicians in far forward environments (roles 1 and 2 of care). Phase III will also include developing and finalizing training methods and protocols for the new device(s). In addition, the regulatory package should be ready for submission to the FDA, including all relevant test data. The contractor should begin establishing relationships with appropriate commercialization partners (manufacturing, marketing, etc.) to facilitate technology transition.
- Bogert JN, Harvin JA, Cotton BA. Damage Control Resuscitation. J Intens Care Med. 2016;31(3):177-86.
- Zhu CS, Pokorny DM, Eastridge BJ, et al. Give the trauma patient what they bleed, when and where they need it: establishing a comprehensive regional system of resuscitation based on patient need utilizing cold-stored, low-titer O+ whole blood. Transfusion. 2019;59(S2):1429-38.
- Spinella PC, Pidcoke HF, Strandenes G, et al. Whole blood for hemostatic resuscitation of major bleeding. Transfusion. 2016;56 Suppl 2:S190-202.
- Spinella PC, Cap AP. Prehospital hemostatic resuscitation to achieve zero preventable deaths after traumatic injury. Curr Opin Hematol. 2017;24(6):529-35.
- Shackelford SA, Del Junco DJ, Powell-Dunford N, et al. Association of Prehospital Blood Product Transfusion During Medical Evacuation of Combat Casualties in Afghanistan With Acute and 30-Day Survival. JAMA. 2017;318(16):1581-91.
- Daniel Y, Sailliol A, Pouget T, et al. Whole blood transfusion closest to the point-of-injury during French remote military operations. J Trauma Acute Care Surg. 2017;82(6):1138-46.
- Nadler R, Mozer-Glassberg Y, Gaines B, et al. The IDF Experience with Freeze Dried Plasma For The Resuscitation of Traumatized Pediatric Patients. J Trauma Acute Care Surg. 2019.
- Spinella PC, Cap AP. Whole blood: back to the future. Curr Opin Hematol. 2016;23(6):536-42.
- Vaught JB. Blood collection, shipment, processing, and storage. Cancer Epidemiol Biomarkers Prev. 2006;15(9):1582-4.
- Gillio-Meina C, Cepinskas G, Cecchini EL, et al. Translational research in pediatrics II: blood collection, processing, shipping, and storage. Pediatrics. 2013;131(4):754-66.
- Thomas S. Platelets: handle with care. Transfus Med. 2016;26(5):330-8.
- Chapter 2: Roles of Medical Care (United States). In Emergency War Surgery, 5th United States Ed., Cubano MA, Butler FK, eds. Office of the Surgeon General, Borden Institute: Fort Sam Houston, TX. Accessed August 25, 2020 at https://www.cs.amedd.army.mil/Portlet.aspx?ID=cb88853d-5b33-4b3f-968c-2cd95f7b7809