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Intravenous Technologies for Pre-hospital Hemorrhage Control and Resuscitation

Description:

TECHNOLOGY AREA(S): Bio Medical 

OBJECTIVE: The objective of this topic is to develop and demonstrate novel intravenous therapies and technologies for pre-hospital management of combat-associated non-compressible traumatic hemorrhage and resuscitation at point-of-injury and en route care. 

DESCRIPTION: In far forward combat scenarios, trauma-associated uncontrolled non-compressible hemorrhage (proximal extremity or truncal) remains the leading cause of fatality for the military, and many of these deaths could be potentially survivable with effective point-of-injury and en route treatment [1-2]. In such hemorrhage scenarios in austere battlefield conditions, transfusion of whole blood and blood components (RBCs, plasma, platelets and coagulation factors), as per Damage Control Resuscitation (DCR) guidelines, can significantly reduce trauma-associated morbidity and mortality [3]. Overwhelming evidence from military based resuscitation studies has indicated the benefits of such blood product transfusion to treat hemorrhagic shock, but the limited availability and portability, special storage requirements and potential contamination risks of these blood products (e.g. platelet concentrates) present severe logistical challenges for their efficient application in combat casualty care in pre-hospital scenarios [4-5]. In this solicitation, we are requesting proposals focused on intravenous transfusable treatments and technologies that address the pre-hospital point-of-injury and en route management of combat-associated traumatic non-compressible hemorrhage and resuscitation. Specifically, this solicitation is seeking intravenously administered molecules, drugs or therapeutic technologies (e.g. nanoparticles) for use at point-of-injury or during en route care to control bleeding and prevent or mitigate hypothermia, acidosis and coagulopathy. The proposal shall address not only preliminary data to support the treatment claims, but it should also provide a plan for effective, logistically supportable deployment during remote Damage Control Resuscitation (rDCR) and prolonged field care (PFC) by medics/corpsmen. In other words, the product should be portable in small volume in a medic or corpsman bag without special storage requirements, shelf-stable for long periods under variety of environmental conditions (cold or heat, ranging from 0-40°C, high altitudes) and easily intravenously administrable. 

PHASE I: Phase I should be aimed at developing a promising and innovative therapy or technology, and evaluating the technical feasibility of said therapy to control hemorrhage through in vitro/ex vivo analysis. Research and development should take into account the challenges of employing the therapy in a far-forward operational environment (e.g. portability, stability, ease of administration) and provide a plan for practical deployment of the proposed solution. The effort should be far enough along that the submitter should not pursue animal studies during this phase. 

PHASE II: Building on the Phase I effort, Phase II prototype development should demonstrate the systemic safety and therapeutic potential of the treatment/technology upon intravenous administration in appropriate models of traumatic hemorrhage in vivo. The focus of these studies would be to establish systemic safety, pharmacology/toxicology parameters and reduction in blood loss, prevention or alleviation of hypothermia, amelioration of acidosis and overall enhancement in survival. Phase II should also provide a detailed plan for practical implementation of the therapies at Point of Injury or en route care including dosage parameters (dosing limits, therapeutic window, etc). The submitter should assess and verify the Technology Readiness Level (TRL) of the proposed therapy at the conclusion of Phase II. The offeror will provide a clear regulatory plan on how they propose to achieve FDA clearance. Follow-on activities shall include the necessary studies requested by the FDA to gain clearance of the technology and/or drug for use in treatment of traumatic non-compressible hemorrhage. The offeror shall focus on working towards getting the therapy FDA-approved for the indication to treat traumatic bleeding 

PHASE III: The submitter should demonstrate the work they would be ready to perform should they be further funded. The submitter shall produce a protocol (dosage and timing of intervention) demonstrating potential medical utility in accordance with the success criteria developed in Phase II, and further develop these capabilities to TRL-5 or -6. The submitter must describe one or more specific Phase III military applications and/or supported S&T or acquisition program as well as most likely path for transition of the SBIR from research to operational capacity. The offeror will provide a clear plan on how FDA clearance will be obtained and to include a detailed commercialization plan and milestones chart. 

REFERENCES: 

1: Eastridge, et al. "Death on the battlefield (2001-2011): Implications for the Future of Combat Casualty Care." J Trauma Acute Care Surg. 2012

2: 73(6 Suppl 5):S431-7. Accession Number: ADA609264

3:  McManus, et al. "Hemorrhage control research on today’s battlefield: Lessons applied." J Trauma. 2007

4: 62(6 Suppl):S14. Accession Number: ADA627857

5:  Butler, et al. "Fluid resuscitation for hemorrhagic shock in tactical combat casualty care: TCCC Guidelines Change 14-01 – 2 June 2014." J Spec Oper Med. 2014

6: 14(3):13-38. Accession Number: ADA614492

7:  Cap, et al. "Blood Far Forward: Time to Get Moving!" J Trauma Acute Care Surg. 2015

8: 78(6 Suppl 1):S2-6. Accession Number: ADA621564

9:  Spinella, et al. "Constant Challenges and Evolution of US Military Transfusion Medicine and Blood Operations in Combat." Transfusion. 2012

10: 52(5):1146-53. Accession Number: ADA615634

KEYWORDS: Combat Casualty Care, Trauma, Hemorrhage, Hemostasis, Transfusion, Damage Control Resuscitation 

CONTACT(S): 

Dr. Crystal Hill-Pryor 

(301) 619-9702 

crystal.d.hill-pryor.civ@mail.mil 

Mr. Wilbur Malloy 

(301) 619-8136 

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