Hemorrhage Detection Technology

Hemorrhage is the leading cause of trauma-related death in both civilian and military populations. More than 33% of prehospital deaths and 50% of deaths occurring within 24 hours of traumatic injury are from hemorrhage. Approximately 50% of combat-related preventable deaths that take place before reaching a military treatment facility (MTF) are hemorrhage related. A study of 4,596 battlefield fatalities from Operation Iraqi Freedom and Operation Enduring Freedom determined that hemorrhage accounted for 91% of potentially survivable fatalities occurring prior to arrival at an MTF. This supports the vital need for early detection and intervention.

This program is intended to support the development or implementation of technological solutions that can provide early diagnosis information and alert of decompensation due to hemorrhage and hemorrhagic shock in order to inform earlier lifesaving interventions and improve patient outcomes. The research project award recipients were selected from the Offerors who responded to MTEC’s Request for Project Proposals (20-01-Hemorrhage).

The Compensatory Reserve Index: Next Steps in Evolving A New Vital Sign to Meet Warfighter Needs

Project Team: Flashback Technologies

Award Amount: $1.23M (additional cost share = $407)

Project Duration: 16 months

Project Objective: Flashback Technologies is currently commercializing a novel vital sign, The Compensatory Reserve Index (CRI). The CRI is a novel vital sign that noninvasively estimates a patient’s ability to tolerate further volume loss due to hemorrhage or dehydration – providing early detection of the risk of hypovolemic shock well in advance of traditional vital signs. CRI provides real-time, continuous patient monitoring within 30 seconds of applying a finger sensor. The purpose of the proposed project is to evolve an existing FDA cleared solution (CipherOx® CRI® M1) to meet or exceed the desired technical requirements as outlined in the RPP for a technology that assists in the early detection of hemorrhage.

Hemorrhage Detection and Treatment System (HDATS)

Project Team: Applied Research Associates

Award Amount: $2.00M

Project Duration: 15 months

Project Objective: We will develop a prototype that will integrate APPRAISE and MTP into the 4TDS platform to provide the ability to anticipate hemorrhage and assist in its management during patient care. Once the algorithm is integrated, we will work with Stanford University to collect de-identified medical data from patients who have, and have not, experienced hemorrhage, to test algorithm accuracy. We will also conduct a usability assessment with medics from all services to evaluate the utility and functionality of the HDATS interface in support of their mission to perform Tactical Combat Casualty Care (TCCC) and Prolonged Field Care (PFC) in Role 1. The proposed effort will integrate the APPRAISE model into the 4TDS application, integrate the MTP algorithm into the 4TDS application, validate APPRAISE and MTP performance on patients’ and hemorrhage patients’ medical data, develop and conduct usability assessments with medics to verify performance, acceptability, and establish a transition plan for FDA approval of the Hemorrhage Detection and Treatment System.

Implementation and Evaluation of the APPRAISE Algorithm for Hemorrhage Prediction & Detection

Project Team: The Henry M. Jackson Foundation for the Advancement of Military Medicine

Award Amount: $1.14M

Project Duration: 12 months

Project Objective: The contractor will use of the APPRAISE Algorithm for hemorrhage detection based on real-time measurements of vital signs. The contractor will implement the APPRAISE Algorithm in a compact (i.e., 4 cubic inches 4 ounces), wearable device (“APPRAISE Device”) that can be placed on the patient to provide a caregiver with an indicator of the extent of hemorrhage or risk for hemorrhagic shock.