Program Summary
Uncontrolled blood loss is the leading cause of death for warfighters on the battlefield, according to the U.S. Army Institute of Surgical Research. The vast majority of such fatalities are from wounds that are not accessible by combat medics for traditional treatments, like direct compression. For example, in the case of internal injuries to the abdominal cavity, medics can neither visualize the damage nor access it to provide treatment. As a result, rapid and uncontrolled blood loss often leads to death before transport from the battlefield to a surgical setting can occur.
DARPA created the Wound Stasis System (WSS) program to pursue a stabilizing treatment that would keep injured warfighters alive until they could be delivered to a surgical setting. WSS began as a basic research program to identify biological mechanisms for distinguishing between healthy and wounded tissue, with the goal of controlling bleeding by binding to the wound. However, as part of that research, a program performer, Arsenal Medical, developed a foam that could itself serve as a treatment to control bleeding and achieve hemostasis. On the strength of these findings, WSS began to focus on the foam material as the primary hemostatic agent.
WSS now aims to develop a stasis material and delivery system, suitable for use by combat medics at the point of injury, to stabilize a wounded patient for medical transport. Such a system would effectively treat non-compressible wounds, regardless of geometry or location within the abdominal cavity, and would not require direct visualization of the wound by the medic.
The specific goals are to:
- Develop an agent to achieve rapid hemostasis and maintenance of that hemostasis for non-compressible, abdominal wounds;
- Design and demonstrate a portable delivery system to transport sufficient wound stasis material to the wound site; and
- Ensure that the hemostatic material can be easily removed in surgical settings.
DARPA plans to continue WSS through approval of a prototype device by the U.S. Food and Drug Administration (FDA), and will cooperate with the FDA to ensure requirements for approval are fulfilled as rapidly as possible so that a wound stasis treatment can be fielded. To this end, work will continue on acute and chronic safety, biocompatibility, optimum dosing, delivery system design, and verification and validation of the final system.