Minimally Invasive Device and Bioabsorbable Hemostatic Powder for Managing Noncompressible Torso Hemorrhage
Abstract
Bleeding is a major cause of death for both civilians and military personnel. During Operation Iraqi Freedom and Operation Enduring Freedom between 2001-2011, 976 injury mortalities on the field were deemed potentially survivable, with 90.9% associated with hemorrhage. When bleeding comes from the torso (abdomen, pelvis, or thorax), it is especially difficult to treat in non-hospital settings and requires immediate surgery, which may be delayed or unavailable, especially without air superiority. Wound care solutions that deliver therapeutics and address prevention of bleeding is a specific Focus Area of the FY2020 CRRP RDTRA funding opportunity. Typical strategies for stopping bleeding, such as compressing the wound, are ineffective for torso bleeds, and current devices for torso bleeds can only delay surgery for 1-3 hrs. There are drugs for stopping bleeding (hemostatic agents), such as thrombin and tranexamic acid (TXA), but they cannot be effectively delivered into the torso to stop bleeding. The proposed work will advance a new hemostatic agent to stop torso bleeding, including severe and complicated bleeds, particularly in multiple medical settings with limited surgical capabilities. This solution is a device that delivers a powder, “CounterFlow,” which effervesces in blood to propel microparticles carrying thrombin and TXA throughout bleeds in bodily cavities. In recent animal studies, CounterFlow halted severe bleeding, even in wounds that cannot be compressed, and was more effective than current hemostatic agents. CounterFlow could be applied to Soldiers with torso bleeding at front-line medical treatment facilities, without surgery, by medical personnel using procedures and equipment that they already routinely use. CounterFlow could stop bleeding and stabilize most patients so that they can survive long enough to reach surgery. CounterFlow is comprised of safe drugs and will degrade in the body so it does not need to be surgically removed later; this could allow physicians to stop minor torso bleeding entirely without surgery in some cases. We will complete the following steps to develop CounterFlow to be used for abdominal and pelvic hemorrhage (CounterFlow-AP). The long-term objective is to reduce death and disability in Service Members and subsequently improve the quality of life for Veterans and their families. 1. Optimize the Formulation of CounterFlow-AP. To increase storage stability and decrease its cost, we will determine the minimum dose of thrombin to halt non-compressible abdominal hemorrhage in swine. 2. Test CounterFlow-AP’s Ability to Stop Severe Non-Compressible Abdominal Bleeding. In swine models, we will test whether CounterFlow-AP can stop several types of abdominal bleeding. This will include modeling trauma with coagulopathy (compromised blood clotting) and mimicking prolonged field care that Soldiers might experience in future conflicts, with delayed medical evacuations. 3. Demonstrate CounterFlow-AP’s Safety in Animal Studies. We will test that CounterFlow is safely absorbed, which is an important requirement for CounterFlow-AP to be approved for treating casualties. 4. Build an Advanced Prototype of a Delivery Device and Establish Manufacturing Processes to Incorporate CounterFlow-AP into U.S. Military Supply Chains. We will establish robust and scalable processes for manufacturing CounterFlow-AP and ensuring it remains effective after prolonged storage. CounterFlow-AP is expected to have a long shelf-life under diverse storage conditions, which will ensure that it is effective in various combat settings. CounterFlow-AP is applicable to all combat personnel at risk of injury and bleeding. Reports estimate that 19% of combat deaths in Afghanistan in 2006 could have been prevented by effective management of bleeding, and CounterFlow-AP specifically addresses bleeding. In Iraq, an effective product that could treat the most difficult bleeds could have sa
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110969
Entities
People
- Christian Kastrup
Organizations
- United States Army