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.

Figure 1

Unique ruggedized lyophilization, storage, and administration container.

Figure 2

Packaging concept for the spray‐dried, S/D‐treated, pooled plasma product. The rehydration fluid is citrate‐phosphate buffer, which allows maintenance of levels of coagulation factors to 7 days at 4°C after reconstitution.