Evaluation of the Platelet Derived Hemostatic Agent (PDHA) Stasix® for Dose-Response Efficacy in a Rabbit Model of Thrombocytopenia
Acute coagulopathy is a major complication affecting both soldiers and civilians sustaining traumatic injuries. Human Platelet Derived Hemostatic Agents (PDHAs) have been developed in an attempt to improve hemostatic capabilities for patients experiencing coagulopathies related to platelet deficit or dysfunction. These products are expected to be particularly vital to soldiers injured on the front lines, where medical facilities are not readily available. One PDHA currently being considered for use by the U.S. Military is Stasix®, a lyophilized isolated platelet and minimal plasma solution, produced by the company Entegrion.
A broader investigation of the efficacy of Stasix® over a range of doses is required to more fully evaluate its deployable potential. A dose response study is therefore needed to arrive at the concentration most likely to correct hemostatic deficits related to insufficient platelet function.
Navy researchers will use a well-documented rabbit (Oryctolagus cuniculus) model of busulfan-induced thrombocytopenia to evaluate several Stasix® doses for their ability to correct deficiencies in clotting time after a small ear laceration. Additionally, the product will further be characterized by analysis of test coagulation parameters in ROTEM® and platelet-like activity in Multiplate® analysis.
The overall goal of the study is to identify an ideal Stasix® dose that will correct hemostatic deficits in thrombocytopenic animals, and therefore be expected to be helpful for patients experiencing coagulopathies related to traumatic events.