Transfusion Service
Balaji Jayakumar
MaxQ Research LLC
Stillwater, OK, USA
The use of fresh frozen plasma (FFP) along with packed red blood cells in the initial resuscitation at different ratios – 1:4/1:2.5 have been shown to be effective for injured patients at risk for coagulopathy and have been widely used in U.S. civilian trauma centers. Frozen plasma has a shelf life of one to three years. However, a notable decline in coagulation factors occurs within days of refrigerated storage post-thawing. While the commercially available plasma thawing devices serve their purpose, they have significant drawbacks. They are heavy (30-150 lbs.), large ( >15”x15”x15”), costly ( >$9k), reliant on a stable electricity source, expensive annual maintenance, challenging clean up and sterilization protocols, and capable of thawing only a limited number of plasma units at a time, with each cycle taking approximately 15-20 minutes. The operational complexity and limited throughput hampers scalability, especially during mass casualty emergencies.
Study
Design/Methods:
This study explores the concept of a novel plasma thawing device (MaxThaw™) that utilizes a heat modulation element (HME) to effectively capture the released energy from a chemical reaction to maintain an appropriate temperature to rapidly thaw plasma while avoiding overheating (See Figure A). The proposed device serves as a scalable, high throughput, economical and fail-proof solution for rapidly and consistently thawing plasma. The design incorporates an activation solution that can be released on demand onto the chemical heater. The frozen plasma unit is placed inside a secondary containment to avoid direct contact with the working fluid. A heat shield layer helps avoid overheating while the activation solution transfers the energy in a dry bath configuration to thaw the plasma unit.
Results/Findings:
It has been shown that 28 minutes of exposure to a 56°C water bath showed no demonstrable degradation of plasma. MaxThaw™ achieved a full thaw of a 300 mL simulant plasma unit from the storage -26°C within 25 minutes (n = 3) of activation with a maximum temperature of 50°C of the working fluid.
Conclusions:
The proposed first-of-its-kind chemical reaction-based plasma thawing device provides an unprecedented non-electric plasma and biologics thawing capability that can support delivery of critical care in Level I trauma centers, expeditionary, resource constrained and emergency settings. In case of a mass casualty event in combat zone, or during a natural disaster (hurricane, earthquake), highway collision and mass shooting incidents, the newly developed MaxThawTM device can be easily distributed and deployed on-demand to make plasma products available for safe transfusion.