Traumatic injuries, such as from road traffic accidents or intentional acts of violence, preferentially affects the young, claims approximately 5 million lives annually, and accounts for more years of potential life lost in the United States than cancer or heart disease. Hemorrhage is responsible for 30-40% of trauma-associated deaths and is the leading cause of the death in the initial 6 hours after injury. Thus, there is a significant need and potential clinical impact for new technologies that can be used by first responders to manage hemorrhage in the initial time frame after trauma. This proposal seeks to develop an intravenous synthetic hemostat for clinical translation for trauma care. The project team includes experts in trauma medicine, bioengineered materials, structural analysis of soft materials, and animal pathology. We hypothesize that a synthetic biopolymer that specifically recognizes and crosslinks fibrin, a protein component of clots, will stop bleeding at wound sites after intravenous injection. In our preliminary work, we have designed an injectable, bioengineered polymer and demonstrated its ability to integrate in forming clots and significantly improve survival in an animal model of trauma when injected intravenously after injury. With the ultimate goal of clinical translation for this material, this project proposes three aims: (i) define the optimal polymer structure and synthesis route, (ii) evaluate the pharmacokinetics, safety profile and storage stability of the material, and (iii) establish efficacy in multiple preclinical animal traumatic bleeding models. Upon completion of these aims, the team will be ready for a pre-IND meeting with the FDA and be within a few years of an IND submission to the Food and Drug Administration (FDA).
There is a great need for alternative methods in early trauma treatment to rapidly stop hemorrhage and reverse coagulopathy. The main goal of this proposal is to develop for clinical translation an injectable, synthetic hemostat that specifically recognizes and strengthens clots at injury sites. We expect that these materials will significantly impact trauma care and save lives by being able to stabilize clots at both inaccessible and external wound sites.
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