Characterization and first-in-human clinical dose-escalation safety evaluation of a next-gen human freeze-dried plasma.

ABSTRACT:

Background

Early plasma transfusion is life-saving for bleeding trauma patients. Freeze-dried plasma (FDP) provides unique formulation advantages for infusion in the prehospital setting. We describe characterization and clinical safety data of the first, next-generation FDP stored in plastic bags with rapid reconstitution.

Study design and methods

Coagulation and chemistry parameters on 155 pairs of fresh frozen plasma (FFP) and their derivative FDP units were compared. Next, a first-in-human, dose-escalation safety evaluation of FDP, involving 24 healthy volunteers who donated either whole blood or apheresis plasma to create autologous FDP, was performed in three dose cohorts (270, 540, and 810 ml) and adverse events (AEs) were monitored. Cohort 3 was randomized, double-bli

SUBMITTER: Cancelas JA 

PROVIDER: S-EPMC9306459 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature