Data from a phase 1 dose-escalation trial reveals that a first next-generation freeze-dried plasma (FDP) product retains the same potency and safety of fresh frozen plasma (FFP). Manufactured in a rugged plastic container, FDP provides readily accessible plasma for rapid transfusion in therapeutic resuscitation protocols for acute traumatic hemorrhage.
The research results are reported in Characterization and first-in-human clinical dose-escalation safety evaluation of a next-gen human freeze-dried plasma, which appears in Transfusion. Westat staff members Melissa R. King, M.S.P.H., Michele Snyder, M.P.H., and David Burgess, M.A., are among the coauthors.
“This FDP product offers life-saving access to plasma in austere environments and is on track to be the first licensed lyophilized plasma product in the U.S.,” notes Ms. King. “It will be particularly useful to the U.S. Department of Defense, which has been supporting the research and development of this FDP product.”