Product Last Widely Used by U.S. Medical Staff in Korean War
By Annette M. Boyle
FORT DETRICK, MD—For the first time since the Korean War, American troops have access to freeze-dried plasma in the field. Currently only available to special forces, the blood product has already saved lives.
The current freeze-dried plasma (FDP) comes from France and has been obtained under an expanded access Investigational New Drug (IND) designation by U.S. Special Operations Command.
To increase availability and better meet the specific needs of U.S. forces, DoD is seeking U.S. Food and Drug Administration approval of a domestically-manufactured product. DoD anticipates that the U.S. product will be available in the field in 2020.
“Plasma is one of the first blood products administered to battlefield casualties at Roles of Care 2 and 3 but is generally not available far forward at the point of injury, largely due logistical constraints,” said Andrew J. Atkinson, product manager, U.S. Army Medical Materiel Development Activity (USAMMDA). Atkinson leads the USAMMDA Pharmaceutical Systems team, which has spearheaded the development of a U.S.-manufactured FDP.
Freeze-drying plasma eliminates the constraints posed by other kinds of blood products. The lighter weight, smaller volume and stable nature of dried plasma makes it easy to carry in backpacks into far-forward positions. Unlike fresh or frozen blood products, it does not require refrigeration.
“The ability to quickly reconstitute a dried-plasma source, when needed, enables faster responses to casualties without the waste that is often associated with thawing fresh frozen blood products with limited shelf lives in anticipation of potential use that does not occur,” Atkinson told U.S. Medicine. Further, he said, “you will be able to use this product up to the point of injury on the battlefield; this is the key for its use.”
Having a dried product also means no waiting for plasma to thaw. Medics can simply reconstitute the dried plasma with sterile water and use it within minutes. The plasma restores volume and provides critical coagulation proteins to hemorrhaging servicemembers until they can obtain whole-blood transfusions and damage-control surgery.
As of this fall, the French FDP had been administered to 16 U.S. soldiers with life-threatening injuries in remote areas of Afghanistan, enabling 10 to survive to transfer of care, according to Army Medicine.
U.S. forces used FDP in World War II, but concerns about transmission of hepatitis, prior to the development of methods to identify viruses in blood, led to its abandonment in this country. A number of European nations, including France, Germany and Norway, have continued to produce and use FDP in military and civilian applications.
Even before the approval of the French product for use by U.S. forces, “U.S. military casualties had been treated effectively by coalition forces with German FDP; German forces have administered over 500,000 units without significant adverse events,” noted Atkinson. Allied forces also used the French product in Iraq and Afghanistan.
U.S. Army Special Operations Command (USASOC) received the French FDP first. They have found it quite useful and ordered 200 units for use this year. “Freeze-dried plasma fills a pre-hospital capability gap in damage control resuscitation,” said Maj. Rodney Saunders, the FDP clinical coordinator and study sub-investigator for USASOC.
This spring, a medical team with the Air Force Special Operations Command was the unit to use the product in that service branch. The Marines Special Operations Command and the Naval Special Warfare Command also have begun using FDP in the field.
While the French FDP has been utilized in deployed settings for decades, it poses a few issues for use on a continuing basis, in the view of the DoD. Consequently, it has been seen as an interim solution for the U.S. forces.
“The major differences between the [French and American] products is that the French FDP is contained in glass bottles, whereas the U.S. product is contained in easily-transported and durable blood bags,” said Atkinson. The U.S. manufactured product will be licensed for use in both military and civilian pre-hospital settings.
Eliminating the weight and concerns about breakage associated with glass bottles offers significant advantages, Atkinson explained. “The battlefield setting is an austere environment where technical and logistical support are often limited or absent, especially at forward echelons of care close to or at the site of injury. This means that any FDP product needs to be easily transported in a medic’s bag with minimal weight in a durable container and easy to use in the chaos of the battlefield.”
Development of U.S. FDP has required a team effort. U.S. Army Medical Materiel Development Activity (USAMMDA) is developing two products using a Cooperative Research and Development Agreement (CRADA) approach under which it is the FDA Sponsor of Record for the IND application. One product is a single-donor FDP, and the other is a pooled-donor solvent detergent spray-dried product.
USAMMDA has a contract with Westat Inc. to conduct the clinical trials. USAMMDA also has a CRADA with Vascular Solutions Inc., the organization which will conduct all the manufacturing development and provide clinical trial material. Vascular Solutions will be the eventual license holder of the product.