title: Comprehensive US government program for dried plasma development.
abstract: Transfusion of plasma early after severe injury has been associated with improved survival. There are significant logistic factors that limit the ability to deliver plasma where needed in austere environments, such as the battlefield or during a significant civilian emergency. While some countries have access to more logistically supportable dried plasma, there is no such product approved for use in the United States. There is a clear need for a Food and Drug Administration (FDA)-approved dried plasma for military and emergency-preparedness uses, as well as for civilian use in remote or austere settings. The Department of Defense (DoD) and Biomedical Advanced Research and Development Authority are sponsoring development of three dried plasma products, incorporating different technologic approaches and business models. At the same time, the DoD is sponsoring prospective, randomized clinical studies on the prehospital use of plasma. These efforts are part of a coordinated program to provide a dried plasma for military and civilian applications and to produce additional information on plasma use so that, by the time we have an FDA-approved dried plasma, we will better understand how to use it.
authors.affiliation: US Army Medical Research and Materiel Command, Fort Detrick, Maryland.
authors.forename: Anthony E
authors.initials: AE
authors.lastname: Pusateri
authors.affiliation: Office of Naval Research, Arlington, Virginia.
authors.forename: Michael B
authors.initials: MB
authors.lastname: Given
authors.affiliation: US Army Medical Materiel Development Activity, US Army Medical Materiel Command, Fort Detrick, Maryland.
authors.forename: Victor W
authors.initials: VW
authors.lastname: Macdonald
authors.affiliation: Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC.
authors.forename: Mary J
authors.initials: MJ
authors.lastname: Homer
mesh_terms: D006801:Humans; D008887:Military Medicine / Q000379:methods*; D009313:National Health Programs; D010949:Plasma; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration