Multi domain Life Saving Trauma Innovations (MuLTI)

This RPP entitled “Multi domain Life Saving Trauma Innovations (MuLTI)” will support the development of highly innovative Materiel Products and new ways, methods, or modifications to existing trauma practice (i.e., Knowledge Products) for future Multi Domain Operations (MDO) where evacuation capabilities may be significantly delayed or unavailable, including decision support, semi-autonomous, and autonomous technologies. Projects should focus on enhancing capabilities at the point of greatest need, including life-saving interventions to be rendered immediately post-injury, during periods of prolonged care in theater, and during en route care within and from theater.  Encouraged characteristics of possible medical materiel solutions include, but are not limited to, concepts that address one or more of the following: mobility, low-weight and cube, low-power, modularity, interoperability, ruggedization, automation, low-complexity, decision supported, closed or semi-closed loop feedback, longer shelf life, temperature stability, low-complexity, regulatory pathway clarity, manufacturability, cost-savings, and/or life-cycle product sustainability.

The Joint Program Committee (JPC)-6/Combat Casualty Care Research Program (CCCRP) is one of six major Defense Health Program (DHP) core research program areas within the DHP medical Research, Development, Test, and Evaluation (RDT&E) programs. JPC-6 is a committee of Department of Defense (DoD) and non-DoD medical and military technical experts in combat casualty care-related program areas. Per the program’s mission statement, JPC-6/CCCRP seeks to drive medical innovation through development of knowledge and materiel solutions for the acute and early management of combat-related trauma on current and future battlefields; including point-of-injury, far-forward, prolonged, en route, and early facility based care. Innovations developed by JPC-6/CCCRP-supported research are applied in-theater across the echelons of care, and within the prehospital and critical care clinical facilities of the Military Health System. These solutions not only help to minimize the morbidity and mortality of combat-related injuries sustained by the Warfighter, they also are often translatable to civilian care. An excerpt from the CCCRP Vision Statement provides further illustration of the program’s needs:

“In responding to mid and long term guidance which is underscored by a predicted loss of air superiority, we must adapt our perspective and tactics with regard to casualty evacuation and the “golden hour” paradigm of OIF/OEF in order to continue to drive down case fatality and died of wound rates. There is a necessary paradigm shift away from transporting casualties to a damage control capability (ROC2/3) to more efficiently bringing “golden hour” medical assets and intervention capabilities to the point of injury.”
– Col Michael Davis, CCCRP Director (2017)

The JPC-6/CCCRP has identified three overarching focus areas for funding under the JPC-6/CCCRP MuLTI Program.

  • Focus Area #1 – Prolonged Field Care and En Route Care (PFC/ERC): The PFC/ERC portfolio seeks to provide materiel and knowledge solutions to enable increased levels of care closer to the point of injury, including care provided during evacuation, to provide patient care for longer time periods when delayed evacuation exceeds available capability and/or capacity, and to extend provider capabilities in order to care for larger numbers of casualties
  • Focus Area #2 – Battlefield Resuscitation and Immediate Stabilization of Combat Casualties (BRISCC): Hemorrhage is the leading cause of preventable deaths among combat casualties occurring before a medical treatment facility is reached. The BRISCC portfolio seeks to provide materiel and knowledge solutions to enable the immediate stabilization at the point of injury.  Current strategic objectives are to provide: (1) technologies to control bleeding in the pre-hospital environment, (2) safer, more effective, and more logistically supportable blood products, and (3) technologies and knowledge sets for improved damage control resuscitation.
  • Focus Area #3 – Neurotrauma & Traumatic Brain Injury (TBI): The Neurotrauma Portfolio (NTP) is focused on closing military-relevant gaps across a broad range of research areas to improve the prevention, diagnosis, management, and treatment of TBI and related sequelae from point-of-injury through recovery. The NTP’s goal is to decrease morbidity and mortality from neurotrauma, mitigate secondary brain injury across all TBI severities, and advance materiel and knowledge development to expand and develop new clinical practice guidelines, care algorithms, therapies, devices, and procedures that advance the decision-making capabilities of medical personnel, enabling earlier intervention and improved outcomes.

The research project award recipients were selected from the Offerors who responded to MTEC’s Request for Project Proposals (19-08-MuLTI).

BurRapid Epidural Drainage Attachment for Traumatic Brain Injury

Project Team: Critical Innovations
Award Amount: $1.44M (additional cost share = $225K)
Project Duration: 37 months
Project Objective: The objective of this program is to advance the development of a production-equivalent BurRapid™ Epidural Drainage Attachment (see Figure below) for management of traumatic brain injury, which provides:

  • Ruggedized portability with reduced size of sterile field setup, to allow for battlefield use
  • Compatibility with existing, widely used, emergency medical equipment to minimize added size profile and easily fit with other gear into a medic or corpsman bag
  • A closed, non-surgical intracranial access approach with improved safety features and prevention of needle “plunging” to allow for use by non-neurosurgeons
  • Rapid decompression of epidural bleeding to prevent secondary brain injury
  • A straight-forward path for FDA clearance, with subsequent commercial transition to military and civilian markets

The specific tasks for the project are:

  • Produce a refined BurRapid™ Epidural Drainage Attachment prototype using an agile human-factors engineering approach
  • Produce a production-equivalent BurRapid™ Epidural Drainage Attachment ready for large-scale manufacturing (TRL 6)

• Perform device studies and prepare materials needed to submit to the FDA for clearance of the new BurRapid™ Epidural Drainage Attachment (TRL 7)

Development of Deployable Bioreactor to Produce Platelet from Cryopreserved Progenitor Cells

Project Team: Platelet BioGenesis
Award Amount: $2.42M (additional cost share = $808K)
Project Duration: 25 months
Project Objectives: Platelets are the principal blood cell responsible for clot formation and blood vessel repair at sites of active bleeding. Platelet transfusion following severe trauma is associated with improved survival. Platelet BioGenesis aims to develop a donor-independent platelet (PLT+) bioreactor that can be established at field hospital sites (Role 3+) to overcome the challenges associated with donor platelet collection, which are exacerbated at military conflict zones due to donor availability, short platelet shelf life, sterility concerns. By extending the utility of our PLT+ Bioreactor to generate PLT+ directly from thawed pre-megakaryocytes (preMK+), the result is a PLT+ Bioreactor that is capable of leveraging established frozen preMK+ stockpiles for rapid, on-demand, production of transfusion-ready PLT+ packs in remote locations.

The specific objectives of this MTEC project are:

  • Determine protocols for preMK+ to PLT+ consolidated differentiation and production. The team proposed to consolidate the two stages, allowing for automated PLT+ production in a stand-alone mobile reactor.
  • Create an automated platform for easy operation of PLT+ Bioreactor. Automation will include both software and hardware.
  • Develop a simplified protocol for buffer exchange and concentration of PLT+. The final objective is to incorporate the purification strategy it into the PLT+ bioreactor automation.

Rugged real-time wearable sensor for assessment of coagulopathy at point of injury

Project Team: Aptitude Medical Systems Inc.
Award Amount: $2.50M
Project Duration: 25 months
Project Objective: In this proposal, we aim to develop the Real-Time Coagulopathy Monitor (RTCM) system to fill the capability gap in real-time assessment of trauma coagulopathy. RTCM is a biosensor platform capable of measuring fibrinogen – the most validated, time-sensitive and actionable biomarker of coagulopathy – directly from patient blood samples at the point of injury and through the continuum of care.

Circulating cfDNA fragments for the detection and diagnosis of traumatic brain injury

Project Team: Children’s Hospital of Philadelphia
Award Amount: $2.19M (additional cost share = $369K)
Project Duration: 39 months
Project Objective: The ultimate objective of this innovative biomarker program for traumatic brain injury is to provide in vivo proof-of-concept development in an area of critical, unmet medical need. The program follows on successful in vivo proof-of-mechanism and efficacy data in large animal models that provide the foundation for rapid development and translation to human study. We hypothesize that the epigenetic state of isolated cfDNA fragments found within the peripheral blood circulation can serve as a prognostic biomarker of TBI mechanism and severity. We plan to demonstrate that these epigenetic signatures can identify and quantify the specific brain cell-types and brain regions specific to individual injuries utilizing two high-fidelity of models of large animal TBI that encompass the heterogeneity of TBI. This disruptive technology has far-reaching implications for prognostication of an individual’s injury, identification of the mechanistic pathways following traumatic brain injury, and the rapid, non-invasive evaluation of response to treatments – pharmacological and non-pharmacological.

In-Field Detection of Acute Subdural Hematomas Requiring Urgent, Life-Saving Treatment in Severe TBI Patients

Project Team: Kitware, Inc.
Award Amount: $1.52M
Project Duration: 38 months
Project Objective: Far-forward, medical personnel lack portable, easy-to-use devices for in-field diagnosis of severe traumatic brain injury (TBI) patients. Major, acute subdural hematomas in these patients produce life-threatening elevated intracranial pressure (ICP > 20 mmHg) which are associated with 90% mortality if detected and treated more than 4 hours after injury, and with only 30% mortality if detected and treated earlier.

Our objective is to develop the software component of an easy-to-use, automated, non-invasive and portable system to determine when urgent, life-saving treatment is needed to address severely elevated ICP. Our system estimates ICP using automated measurements of the optic nerve sheath diameter (ONSD) from ultrasound images.  Our ONSD measurement algorithm promises to be a reliable proxy for the detection of ICP > 20 mm Hg because it incorporates an innovative statistical model of patient-specific correlations (i.e., age, ocular orb size, and BMI) for determining when a patient’s ONSD changes are indicative of a clinically significant increase in ICP.  Additionally, we will compare the performance of our ICP estimation algorithm in conjunction with five different, commercially available, point-of-care ultrasound devices, thereby comparing their suitability for artificial intelligence algorithms for in-field trauma injury assessment.