The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to enable rapid blood clotting in order to treat bleeding after a traumatic injury The majority of deaths that occur within the first 24 hours following a traumatic injury are the result of hemorrhage. The scientific merits of the project stem from the biochemical advantages of using the physiological initiator protein of coagulation, tissue factor, impregnated in the dressing, rather than a foreign substance such as those used in current dressings. These foreign substances have no "off" switch, and can cause downstream blood clots. Tissue factor, in contrast, has natural regulatory proteins that limits its ability cause downstream clots. Tissue factor is also the fastest known initiator of blood coagulation, and can cause complete blood clotting in 12-14 seconds. This dressing has the very real potential to prevent deaths from hemorrhage, and the outcomes from this project will literally save lives. The results from this project will also provide compelling pre-clinical data to demonstrate feasibility of the product, which will be attractive to strategic partners and/or private investors for further commercial development of the hemostatic dressing.The proposed project relies on a new intellectual paradigm to initiate coagulation with a hemostatic dressing. Trauma is the leading cause of death for all persons between the ages of 1 and 44 years. The majority of deaths that occur during the first 24 hours following a traumatic event are the result of hemorrhage. The intellectual merits of this project stem from the biochemical advantages of using the physiological initiator of coagulation, tissue factor, rather than a xenobiotic initiator such as those used in current commercial hemostatic dressings. Tissue factor has natural regulatory proteins, particularly tissue factor pathway inhibitor, that prevents downstream blood clot formation. The technical hurdles addressed by the proposed R&D plan include the optimization of the amount of tissue factor on the dressing that is required for rapid blood coagulation. In addition, the optimized dressings will be compared to the current military standard dressing in a pre-clinical hemorrhage control study in swine. The development of a tissue factor-impregnated dressing that is significantly more effective than the current military standard dressing in this swine model will be a major theoretical breakthrough.
