Tranexamic Acid Autoinjector for Immediate Treatment of Hemorrhage on Battlefield
Abstract
Loss of blood (hemorrhage) is a common consequence of injury (trauma) and is the leading cause of potentially survivable deaths both on the battlefield and among civilians. Between 2001 and 2011, it was attributed to over 90% of all potentially survivable U.S. combat fatalities. Within the civilian population, hemorrhage is responsible for most of the 40,000 trauma deaths per year that could be prevented with an appropriate and early medical intervention. Therefore, to save lives, it is crucial to treat hemorrhage as quickly and as effectively as possible. Furthermore, in contrast to hemorrhage in the extremities that can be effectively controlled with a tourniquet, non-compressible torso and junctional hemorrhage is extremely difficult to manage in pre-hospital settings and the only definitive treatment is a surgery. The body’s natural response to bleeding is to form a blood clot. However, the body must also ensure that the clot forms only at the site of injury and not within intact blood vessels by balancing the mechanisms of clot formation and clot breakdown. In traumatic injury, especially when it is severe, these mechanisms often become dysregulated and shift to clot breakdown, which leads to weak clots that are unable to stop the bleeding. A well-known and effective drug that inhibits blood clot breakdown mechanisms to facilitate formation of strong clots is tranexamic acid (TXA). It is commonly used in surgeries where large loss of blood is expected (for instance, heart and joint replacement) and is the first drug to be administered by combat medics in cases of significant hemorrhage. It significantly reduces blood loss volumes and improves survival in traumatic hemorrhage. Unfortunately, currently, the only way of administering TXA is by intravenous or intraosseous (into bone marrow) injection. This requires the medic to transfer TXA from its vial into an administration device, establish vein or bone access, and perform a slow push. This procedure can be challenging or impossible in combat settings. As a result, many opportunities to use TXA are lost or delayed (TXA is most effective when administered immediately after injury; after 3 hours, it loses its efficacy). The optimal solution to this problem is to administer TXA by intramuscular injection using an auto-injector device that not only medics, but also Soldiers, can carry and use for self- and buddy-aid when instructed to do so by a medic. To administer TXA with an auto-injector, a user simply presses the device against the injection site (for example, a thigh) for a few seconds to deliver a dose of TXA by intramuscular injection, even through several layers of clothing. In effect, this guarantees that TXA can be administered essentially instantaneously in almost any conditions, well within the first hour from injury in which most fatalities occur, AKA the Golden Hour. A TXA auto-injector would improve outcomes of traumatic hemorrhage, including non-compressible hemorrhage; reduce the amount of whole blood needed for transfusions; and make medics more efficient, which is particularly important in mass casualty scenarios. In effect, it would optimize treatment of life-threatening hemorrhage and mitigate fatalities. It will benefit both active Service Members and the civilian population. This 12-month project proposed by Aktivax aims to advance development of a TXA auto-injector and position it for clinical testing as required for its approval by the FDA. Since we have already developed an auto-injector platform specifically designed to meet the requirements of the military, the proposed work is limited to studies required by the FDA to allow use of the TXA auto-injector in humans in clinical trials. The auto-injector manufacturing line will be put in place at the beginning of 2021 and will be available to support the TXA auto-injector program. We have also developed a new formulation of TXA appropriate for a low-volume intramuscular
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210225
Entities
People
- Cindy Munoz
Organizations
- United States Army