The Department of Defense has received emergency use authorization from the Food and Drug Administration to use pathogen-reduced, leukocyte-depleted, freeze-dried plasma for the emergency treatment of hemorrhage and coagulopathy in combat situations.
Hemorrhage and coagulopathy are the leading causes of preventable deaths among combat trauma casualties. While plasma contains proteins that help clot blood and thus can treat these conditions, it isn’t feasible to keep it on hand for combat emergencies in the field because of logistical and operational requirements, such as refrigeration or thawing periods. This freeze-dried plasma product, on the other hand, can be easily reconstituted in situations in which refrigeration isn’t possible.
The FDA authorization allows for the use of a French-made, powdered, freeze-dried product. Thiscame about in part because of established between the FDA and the Department of Defense in January 2018.
“Earlier this year, we reaffirmed our commitment to the Department of Defense and to the dedicated men and women protecting our country, by expediting the development and availability of safe and effective, priority medical products that are essential to the health of our military service members,” said FDA commissioner Scott Gottlieb, MD. “This is especially true when it comes to products used to treat injuries in a potential battlefield setting.”
More information about this emergency use authorization can be found in the FDA’s full press.