Page 47 - JSOM Spring 2020

Freeze Dried Plasma Administration
Within the Department of Defense Trauma Registry

Camaren M. Cuenca *; Grigory Charny, MD ; Steven G. Schauer, DO, MS 3
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ABSTRACT
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Hemorrhage is common among the combat injured, and an issue, resulting in the halt of its use by US forces in 1968.
plasma plays a vital role in blood product resuscitation. Re- The French Military Blood Institute continued to produce and
garding freeze dried plasma (FDP), US forces have had limited use FDP in French military forces, but this was ended in 1985
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access to this product compared with other countries. In 2018, due to risk of HIV infection. FDP was largely abandoned in
the US Food and Drug Administration provided emergency favor of albumin as a safer alternative for war resuscitation
authorization for Department of Defense (DoD) use through despite its limited use for trauma resuscitation. 10,11 However,
the newly congressionally directed military use pathway. We as reliable pathogen detection and reduction methods became
describe the documented uses of FDP by US forces by perform- available in the 1990s, FDP returned as a favorable product
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ing a secondary analysis of two previously described datasets is combat resuscitation. The French military resumed pro-
from the DoD Trauma Registry. In 11 identified cases, the me- duction and use of FDP in 1994, and its use has progressively
dian age was 28; cases were most frequently male, part of Op- spread among European allies. 9, 13 With the use of FDP becom-
eration Enduring Freedom, with US military affiliation, and ing more widespread in war resuscitation, it was only time un-
injured by explosive or gunshot wound. The median injury til the United States revisited the approval of its use in combat
severity score was 21; most did not receive a massive trans- care.
fusion. Most survived to hospital discharge. Ongoing surveil-
lance is warranted to optimize the implementation of FDP into Due to the lengthy timeline for US Food and Drug Adminis-
military prehospital guidelines, training, and doctrine. tration (FDA) approval for a US-based FDP product, the US
military received FDA approval to collaborate with the French
Keywords: freeze dried; plasma; combat; military Centre de Transfusion Sanguine des Armées and use their dried
plasma products in combat casualty care. The US military
has had limited use of the French lyophilized plasma (FLyP)
through an expanded access Investigational New Drug (IND)
Introduction application since 2011. In July 2018, the FDA announced that
it had granted emergency use authorization (EUA) to the US
Hemorrhage is the leading cause of potentially preventable
death in US military combat casualties. Prehospital blood DoD to enable the emergency use of FLyP when fresh-frozen
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products have a demonstrated mortality benefit. Specifically, plasma (FFP) is not available or practical (Figure 1). How-
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plasma treats the coagulopathy of trauma, making it a valu- ever, acquisition efforts for military-wide use are still under
able resource for resuscitation. However, the use of blood and way. Despite the use of this life-saving intervention under the
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plasma products in austere environments is logistically chal- IND for several years, its use by US forces has not been exam-
lenging due to weight, volume, and refrigeration requirements. ined beyond very limited reports. We are seeking to describe
Maintaining an active cooling container in a combat zone is the use of this FDP product under the IND status.
unreliable for long periods of time, and having a reliable re-
frigeration source near the point of injury is challenging given Goal of This Study
the often-limited space in vehicles and helicopters. One pro- We describe the documented uses of experimental freeze-dried
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posed solution to this problem is FDP, a fluid-extracted resus- plasma use within the DoD Trauma Registry (DoDTR).
citation product that requires reconstitution before use.
Methods
Emerging in the 1930s, FDP was originally produced and used
by Allied powers during WWII using pooled products from Data Acquisition
multiple donors. As the use of FDP was realized and began We identified cases as part of two studies from the DoDTR,
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to spread, it became apparent that the transmission of hepa- which have been previously described with specific attention to
titis C virus due to improper donor screening was becoming prehospital and emergency department interventions performed
*Correspondence to Camaren M. Cuenca, US Army Institute of Surgical Research, 3698 Chamber Pass, JBSA Fort Sam Houston, TX 78234 or
ccuenca@nd.edu
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1 Ms Cuenca is with the US Army Institute of Surgical Research, JBSA Fort Sam Houston, TX. LTC Charny is with the Uniformed Services Uni-
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versity of the Health Sciences, Bethesda, MD. MAJ Schauer is with the US Army Institute of Surgical Research, JBSA Fort Sam Houston, TX;
USA Uniformed Services University of the Health Sciences, Bethesda, MD; Brooke Army Medical Center, JBSA Fort Sam Houston, TX; and 59th
Medical Wing, JBSA Lackland, TX.
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