The U.S. Food and Drug Administration issued a new emergency use authorization on August 8 allowing the use of freeze-dried blood plasma by military medical personnel or people working on deployment for the military.
Dr. Steve Schauer, an Army emergency medicine physician for nine years, is actively advocating for the widespread adoption of freeze-dried plasma – technically known as OctaplasLG powder – throughout the military.
“This is a great achievement for the Department of Defense because they helped move this forward by working with Octapharma, a European company,” Schauer said. “The product is already on the market in other countries. Essentially, they are bringing their product to the United States.”
As the post-9/11 wars progressed, military medicine realized that blood products were critical to treating battlefield injuries that often lead to death from blood loss. Unlike other treatments such as saline infusions, blood substitutes restore the trauma patient’s blood clotting and oxygen-carrying capacity.
“(Non-blood treatments) don’t do anything in terms of tissue oxygenation, which is an important factor, and they definitely don’t do anything for your clotting factors. So they don’t help with blood clotting and they don’t help with tissue oxygenation, which are the two things you need,” Schauer said. “Whole blood and other prehospital blood products do those things, but they bring with them a lot of logistical cost challenges.”
However, blood must be stored at cold temperatures and spoils quickly even under the best conditions. However, freeze-dried plasma has a shelf life of two years and can be stored at room temperature. Even after reconstitution, it remains usable for 8 hours.
Special operations medics have been carrying French-made freeze-dried plasma for over a decade. Army Green Berets medics were authorized to carry the French version in 2011, Marine Raiders gained access in 2016, and Navy SEALs and Air Force Special Forces began carrying it in 2017.
However, low supplies of the French product kept it out of the hands of medics in larger conventional armed forces and other health care providers. The new FDA approval is likely to lead to increased supplies, although it is unclear when OctaplasLG powder will reach a medic’s first aid kit.
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The FDA’s EUA status for OctaplasLG powder is for the treatment of bleeding or impaired blood clotting factors. The treatment is intended solely for persons involved in military combat operations when plasma is not available or the use of plasma is “impractical.”
“Although FDP doesn’t solve the problem of oxygen delivery, it does solve some of the coagulation problems because it now restores all of the blood clotting factors that they just used up trying to form a clot,” Schauer said. “And as they bleed out and lose volume, they naturally lose some clotting factors as well. So instead of diluting all that, you now replace the factors that they lost with human-derived clotting factors.”
However, OctaplasLG powder is derived from human sources and can cause transfusion reactions similar to those seen with blood products. However, Schauer says there is little risk because it is designed to be “universally compatible.”
“FDP goes through a solvent purification process that removes a lot of the different things that can cause a reaction, like some of the white blood cells, and potentially reduces the risk of transmitting infection,” Schauer said. “So there’s a lot less risk than using fresh product. But it’s similar things you have to look out for with plasma products.”
Schauer said the production of OctaplasLG powder is simple and involves mixing the freeze-dried plasma with sterile water before giving it to the patient intravenously or intraosseously. Training of the medical professionals is relatively simple and builds on the skills they already have.
