Development of a syringe/sonication device employed to administer DDFPe in the prehospital setting - PROJECT SUMMARY/ABSTRACT
Clinical Challenge: In acute trauma, in the civilian setting, hemorrhage is the second most leading cause of
death.1 In the military setting, 90% of potentially preventable deaths are caused by hemorrhage due to trauma.2,3
56% of civilian and 87% of military mortality caused by traumatic hemorrhage occurs pre-hospitalization. Adverse
outcome in trauma patients during prehospital resuscitation is due to the unavailability of blood transfusions in
the field leading to insufficient oxygenation. Traumatic brain injury (TBI) is the leading cause of disability in both
civilians and military.4 Specifically, in the pre-hospital setting, hypoxia in TBI may be the most important
secondary injury affecting mortality.5,6 A therapy that can be deployed rapidly, and safely en route to the hospital
in the civilian and the battlefield settings could greatly reduce the trauma mortality rates due to both hemorrhage
and TBI. We are developing an oxygen therapeutic, dodecafluoropentane emulsion (DDFPe), which has the
potential to be administered in the prehospital setting. This could greatly prolong the time window for
administration of follow-on therapies to trauma patients, thus increasing the likelihood of successful recovery.
All fluorocarbon emulsions undergo a gradual increase in particle size due to Ostwald ripening.7 DDFPe has a
two-year shelf-life at 4°C, about one year at room temperature and shorter shelf-life at higher temperatures due
to particle size increase beyond specifications. We have discovered a means of maintaining the particle size of
DDFPe within specification that affords at least a two-year shelf life even under potentially extreme conditions.
Availability of an oxygen therapeutic in field conditions would allow it to be used in emergent settings
maintaining vital oxygenation in civilian and military trauma.
Overarching Hypotheses: Sonication of pre-filled syringes of DDFPe can be employed to produce in spec
nanoemulsion suitable for IV administration. Ultimately, battery powered, portable, easy to use pre-filled
syringe/sonication systems can be developed for field based applications.
Specific Aims: 1. Demonstration of optimal acoustic parameters. 2. Demonstration that product composition is
not affected by sonication.
Expected Outcome: Successful completion of the study will determine the optimal ultrasound parameters to
enable design of a portable, battery powered syringe/sonication device in Phase II of this development program.
