Self crosslinkable hydrogel as an embolic agent for traumatic hemorrhage control

ABSTRACT Trauma is the th leading cause of morbidity and mortality after heart disease malignancies and lower respiratory illnesses in the United States Blunt abdominal trauma BAT is commonly caused by vehicular accidents and falls Uncontrolled bleeding is a major factor in early mortality after trauma contributing to to of trauma related deaths Transcatheter arterial embolization TAE techniques play a significant role in the comprehensive modern treatment of traumatic vascular injuries to solid organs and extremities Current embolic agents have proven to be problematical with regard to non resorbability or unpredictable resorption catheter clogging or cytotoxicity due to the presence of organic solvents Thus there is a need for a new multi potent embolic agent formulated with biocompatible components that addresses these issues to more effectively manage hemorrhage in trauma patients The long term goal is to obtain a simple safe and more effective treatment method for traumatic hemorrhage control after BAT EmboMedics is developing a resorbable hydrogel that will improve clinical practice by providing an embolotherapeutic solution that is well suited to a trauma care setting being easy to mix and inject self crosslinkable resorbable nontoxic and travelling distally from the site of injection Preliminary data show that the hydrogel has an adjustable gelation time and resorption rate is non cytotoxic to endothelial cells and capable of occluding arteries which is promising for hemorrhage control Compared with Gelfoam a commonly used embolic agent for trauma this hydrogel would obviate the need for manual cutting to size prior to use Compared to liquid local hemostatic agents such as N butyl cyanoacrylate super glue and Onyx the hydrogel is advantageous as it is easier to manipulate resorbable and non cytotoxic While not radiopaque this novel hydrogel can be loaded with contrast to ensure visibility during embolization Therefore EmboMedicsandapos hypothesis is that its novel hydrogel can serve as a naturally derived nontoxic and completely biodegradable embolic agent that is more effective than existing agents for hemorrhage control The objective of the proposed research is to validate the use of this novel hydrogel as an embolic agent for the control of internal bleeding that occurs with BAT This project will evaluate the efficacy of the resorbable hydrogel in a porcine renal model Specific Aim This will be accomplished by creating a trauma model in the porcine kidney following an established procedure Aim A This will be used to test the efficacy of the hydrogel as compared to a non resorbable embolic product in hemorrhage control Aim B The long term hemorrhage control and resorbability of the embolics will be evaluated over weeks Aim C Necropsy and histopathological analysis of the tested kidneys will be performed to evaluate the extent of infarction non target embolization hydrogel resorption recanalization and tissue response Aim D NARRATIVE Uncontrolled bleeding is a major factor in early mortality after blunt trauma where transcatheter arterial embolization TAE techniques play a significant role in the comprehensive modern treatment of traumatic vascular injuries Current embolic agents have proven to be problematical with regard to non resorbability or unpredictable resorption catheter clogging or cytotoxicity due to the presence of organic solvents Thus there is a need for a new multi potent embolic agent formulated with biocompatible components to manage hemorrhage in trauma patients This project will evaluate the safety efficacy and long term effects of a novel hydrogel that would serve as an embolic agent for the control of vascular bleeding following laceration of porcine kidney as a trauma model