Trauma-associated non-compressible hemorrhage remains the principal cause of preventable mortality in the battlefield. Platelet transfusion is a critical component for treating such hemorrhage. However, platelets have limited portability, high risk of contamination, and short shelf-life (3-5 days), which severely limit their pre-hospital battlefield use. Improving pre-hospital utilization is currently under investigation with cold-stored and lyophilized platelets, with limited success. In this framework, there is a significant need for an IV-injectable hemostatic product with excellent portability and shelf-life, that enables platelet-mimetic hemostasis when platelets are unavailable. We have developed a synthetic nanoparticle technology, SynthoPlateTM, that can mimic platelets hemostatic functions while allowing large-scale manufacture, sterilization to reduce contamination, long shelf-life and small-volume portability for point-of-injury use. SynthoPlateTM has shown hemostatic and survival benefit in small and large animal trauma models. Building on that, the goal of this proposal is to study SynthoPlateTM stability and biofunction upon lyophilization/reconstitution (Aim 1) and battlefield-relevant environmental exposure (Aim 2), to establish its pre-hospital logistical and functional viability. Additionally, in Aim 3 (Option), the optimal SynthoPlate-to-Platelet ratio will be established for effective hemostatic function. These in vitro studies will guide subsequent pre-clinical Phase II studies with SynthoPlateTM, to significantly advance its potential for pre-hospital hemorrhage control.
