Delivering Life-Saving Technology to Combat Casualties in the Multidomain Battlefield (MDB): Self-Sensing Hemorrhage Control and Resuscitative Catheter (SHARC)
Abstract
This proposal addresses non-compressible torso hemorrhage, which is defined as a high priority capability gap by the Fiscal Year 2019 Peer Reviewed Medical Research Program. Specifically, this proposal addresses two areas of research encouragement: development of early detection and treatment of hemorrhage (uncontrolled bleeding), and research on the stabilization of polytrauma (multiple injuries in one patient), with attention to impact on traumatic brain injury. We will develop a medical device that is capable of stopping bleeding in the abdomen (belly) and pelvis (hips and groin). In military combat casualties, these injuries to the abdomen and pelvis are particularly deadly as they cause rapid blood loss and are not easily addressed with other bleeding control techniques like tourniquets and bandages. We have developed, and the military has fielded, a first-generation bleeding control device that is introduced into the blood vessels in the trunk and advanced into the chest, where it can be activated to stop ongoing bleeding in the abdomen and pelvis while diverting life-sustaining blood flow to the heart and brain. This currently fielded device, the ER-REBOA™ catheter, has also been widely adopted in civilian trauma hospitals in the US, Canada, and Europe. However, this device has limitations that need to be fixed in order for it to be used in future military conflicts where immediate helicopter evacuation to large hospitals may not be possible. There are two limitations on the current device: (1) it can only be used for short periods (30-60 minutes) without causing significant risk of irreversible injury to the intestines and kidneys, and (2) it is not well-understood if the device can be used on patients with multiple injuries including traumatic brain injury. This proposal addresses these limitations by developing a next-generation bleeding control device to extend safe use time and experiments to investigate the effect of using it in situations where bleeding and brain injury occur together. After developing a prototype with these important innovations, we will test the device in an animal model that simulates military casualties injured in war. These simulated casualties will have life-threatening bleeding and be treated with the bleeding control device described above. These research results will immediately benefit military casualties as the information will be incorporated into existing guidelines, which guide doctors on the treatment of combat casualties. The testing of the bleeding control device will also be used to guide the production of a final product, which will be submitted to the Food and Drug Administration for approval so it can be provided to doctors caring for the most severely injured combat casualties. This research team includes scientists, engineers, and physicians working in military research programs and military hospitals, and a medical device company, all of whom have a proven track record of collaborating together to develop innovative medical products and bring those medical products all the way through the research process and into military hospital use. We will use the same approaches that have proven effective in previous efforts to field products and medical knowledge to improve the care of military casualties. Likewise, this team has proven the ability to bring these innovations to civilian hospitals to improve the care of patients injured in car accidents, falls, shootings, stabbings, and other traumatic events. When completed, the knowledge and medical devices resulting from this research will be made available in civilian trauma centers to improve the care of Veterans, military families, and other Americans. Portions of the products of this research will have immediate use at the end of the research project, while medical devices will require 3-4 additional years of work to obtain approval from the Food and Drug Administration and be used in patient care.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010524
Entities
People
- David Baer
Organizations
- Prytime Medical (United States)
- United States Army