Background: Uncontrolled blood loss is a major cause of death in traumatically injured patients, in both military and civilian populations. A variety of hemostatic agents have been developed in an attempt to stop bleeding from sites that are not amenable to tourniquet application, like the neck, abdomen, and groin. A novel insoluble and bioabsorbable foam made of a polysaccharide polyelectrolyte complex of chitosan and starch is proposed for testing in a swine hemorrhage model. This foam can have its mechanical properties tuned to expand as desired to apply pressure to bleeding wounds and does not have to be removed if used internally. Because chitosan is one of the principal components, the foam does not rely on endogenous clotting factors to form a clot, but rather cross-links red blood cells based on the negative charges of the red blood cell surfaces and the cationic chitosan.Objective/Hypothesis: The objective of this work is to refine and demonstrate efficacy of this bioabsorbable hemostatic agent for military and civilian applications using a swine femoral artery hemorrhage model. It is hypothesized that the cross-linked chitosan and starch foam offers optimal hemorrhage control based on its ability to apply pressure with expansion in the wound as it absorbs blood, and then as a novel mechanically stable insoluble gel (serving as a conforming barrier). The chitosan promotes hemostasis, resulting in improved patient hemodynamic stability and reduced blood loss.Specific Aims: (1) Compare different formulations of the foam to determine the most efficacious. (2) Compare optimal formulation with current Tactical Combat Casualty Care standard, QuikClot Combat Gauze. (3) Establish an extrusion process for mass production and packaging of the foam to assure quality and homogeneity of the product.Study Design: The standardized swine femoral artery hemorrhage model developed by Kheirabadi et al. will be utilized to evaluate the novel biofoam’s performance against QuikClot Combat Gauze (n=10). Two formulations of the biofoam will be compared (each with n=10). Biofoam samples will be produced with a range of mechanical and chemical properties (compression modulus, compression strength, resiliency, fluid absorption capacity, and the ability to be packaged for simple and immediate Soldier use) for use in in vivo swine evaluations to optimize the foam’s composition. Production extrusion processes will then be developed to produce optimized foam compositions on a large scale achieving uniformity and a direct path to a commercially viable product for Soldier combat wound treatment.Impact: This product would be ideal for a prolonged field care whereby a patient bleeds from a non-compressible or junctional area, like the neck, axilla, or groin, which are not amenable to tourniquet application. Due to its predicted ease of use and efficacy for bleeding wounds of all shapes and depths, all Service members would carry this product with them and with little to no training be able to utilize it for their own or others’ wounds. Because hemorrhage is the leading cause of death in combat, this product has the potential to improve mortality rates, particularly those preventable deaths that occur prior to arriving at medical treatment facilities when evacuation times are prolonged.
|Effective start/end date||6/1/18 → 5/31/21|
- Congressionally Directed Medical Research Programs: $1,436,358.00