Topical Venom-Activated Hydrogel Hemostatic (Procoagulant + Antifibrinolytic) Agent
Abstract
Proposal Focus: We propose to improve the trauma casualty outcomes by stopping bleeding using a portable, potent, snake venom-based gelating hemostatic agent that is suitable for complex wound sites, including torso injuries where there is a lack of treatment options. Our proposal is founded on a new technology to control bleeding, by incorporating two snake venom proteins, one to clot the blood and the second to stop the blood clot from breaking down. Thus, we have taken the novel approach to use the deadly power of nature to kill to save lives by combining these snake venom proteins with a synthetic temperature-responsive gel that reinforces the blood clot in order to bring about rapid and stable blood clot formation stopping the bleeding. We have striking data from a small animal model of bleeding showing that, when applied topically, we reduce both blood loss and bleeding time by more than threefold compared to the body’s natural ability to stop bleeding. Our proposal will build on this research to extend the evaluation of this technology into preclinical models of bleeding for both topical and intracavity torso injuries. We will address two key focus areas of the FY21 JPC-6/CCCRP BRISCC Award: 1. Innovative and novel technologies that can stop life-threatening bleeding in the torso region of patients who are delayed in receiving definitive surgical care. 2. Innovative and novel devices, drugs, therapies, and clinical practice techniques to treat combat-related and trauma-induced injuries in the pre-hospital setting. Research Impact: We will establish pipelines to produce a robust and stable technology to stop bleeding specifically and rapidly that is compatible with a simple, self-contained portable applicator ready for field use. Employing a swine preclinical model of bleeding, we will evaluate the new technology’s safety and effectiveness to stop bleeding in animals with both normal and impaired abilities to stop bleeding to mimic a combatant suffering a major trauma injury. Two types of injury will be employed: a femoral artery injury, where compression can be used, and a liver torso-based injury. We have an experienced team of researchers with backgrounds in key areas of military trauma surgery, veterinary anesthesiology, swine preclinical bleeding models, materials chemistry, biology, and synthetic venom protein production. Together we will provide research impact by well-designed, robust, quality-controlled evaluations that will lead to the development of a new technology that we believe will bring solutions to save combat lives in the premedical facility phase of care. Outcome Timeline: This proposal will evaluate two key aspects of this new technology: safety and how effective it will be in preclinical models of bleeding. Taking it to a proof-of-concept stage would require expert regulatory advice to progress to first-in-human clinical trials. However, current advice indicates that, for topical application, the route to patient outcomes is expected to be rapid compared to intra-cavity application. Benefit: This proposal addresses the extreme need for improved combat casualty care in the premedical facility phase of care where death in casualties with potentially survivable injuries due to bleeding is reported to be as high as 90.9%. Death due to bleeding is considered a preventable death. Our technology addresses the two reasons for uncontrolled bleeding, an inability to clot the blood and or the premature breakdown of the blood clot in this one simple product that could be delivered by the combatant themselves, unlike any other product employed by the U.S. military, enabling treatment even under fire. In a civilian setting, injury is a leading cause of death and disability worldwide, with an estimated 5 million deaths a year, with road traffic accidents being the major cause of mortality. A large portion of these deaths are also attributed to uncontrolled bleeding, where
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210182
Entities
People
- Alan E. Rowan
Organizations
- United States Army
- University of Queensland