DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Non-Battery Powered In Situ Thermoregulated Flexible Packaging for On-Demand Warming of Blood Products

Principal Investigator: RAHMAN, ARIF
Institution Receiving Award: MAXQ RESEARCH LLC
Program: CRRP
Proposal Number: RC200307
Award Number: W81XWH-21-2-0037
Funding Mechanism: Rapid Development and Translational Research Award
Partnering Awards:
Award Amount: $1,861,157.00
Period of Performance: 9/15/2021 - 9/14/2023


PUBLIC ABSTRACT

Severe injury in battlefield or a traumatic accident can lead to excessive blood loss (hemorrhage), which is the number one reason for trauma related deaths in the United States. The injury severity with continued bleeding reduces the ability for blood to clot (coagulopathy). Controlling bleeding, maintaining minimal organ perfusion with reasonable use of fluids, and fighting against overall blood failure due to hemorrhagic shock can substantially reduce the possibility of death. Transfusion of blood products, especially plasma, early in the injury can help compensate for the blood loss while restoring hemostasis. Most blood products are stored and transported at colder temperatures, typically 1-6 °C. However, infusion of colder blood products directly into a bleeding patient could result in hypothermia, which is one of the major reasons for increased mortality. In addition, the use of plasma in combat/remote settings is severely limited by logistical and operational challenges. The logistical difficulties include the need for cold storage facilities, specialized cold chain product for transport, and, more importantly, a long thawing process of frozen plasma. Freeze-dried plasma (FDP), an alternative to traditional plasma, can mitigate logistical and operational challenges experienced during early fluid transfusion for trauma patients in the battlefield. Casualties on far-forward austere environments, as well as remote civilian hospitals and medical facilities that are challenged by long pre-hospital transport times, can benefit from temperature-stable, long-shelf-life FDP. FDP can be stored and transported in Soldier backpacks to treat wounded combat personnel in the field and provides the flexibility of simultaneously deploying a high volume of on-demand field care in austere environment. In the battlefield, reconstitution of FDP with ambient temperature sterile water could result in colder infusion product that can lead to hypothermia. Battery-operated portable devices with in-line warming capabilities are used to prevent hypothermia in case of pre-hospital transfusion. The current state-of-the-art devices for fluid warming involve battery-operated electric heating elements that are expensive, heavy, require increased product training time, and exhibit a large logistical footprint. These devices, depending on their size, also vary in output temperature, time required to reach desirable temperature, warming performance over time, and the total volume that can be warmed depending on battery capacity. These limitations of the current portable warming devices warrant an alternate solution that is easy to use, smaller and lighter to carry, and can be used on demand without the need for a battery in warming fluids for early resuscitation in all emergency civilian and military applications. In this research, MaxQ, in collaboration with the U.S. Army Institute of Surgical Research), aims to develop, test, and deliver an economical and efficient “in situ thermoregulation system” (iTS) to precisely regulate temperature of reconstituted FDP and other transfusion products. MaxQ’s proposed MaxExoTM blood warmer design leverages chemical reaction to generate on-demand energy for warming the blood products. This will result in a smaller, lighter, and more robust blood-warming package that can be utilized without the need for electricity. With the proposed solution, every Soldier in battlefield can carry FDP components and the MaxExo warmer in their backpacks or medic packs. When the need arises, a single person can reconstitute the FDP and activate the MaxExo warmer simultaneously to facilitate transfusion under medically optimal conditions. Similar to military application, civilian hospitals and Level I Trauma and emergency care programs can benefit from utilization of the MaxExo plasma warmer in case of pre-hospital transfusion, patient transfer, and also during natural disaster and mass shooting incidents.