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

Autor: Cancelas JA; Hoxworth Blood Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA., Nestheide S; Hoxworth Blood Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA., Rugg N; Hoxworth Blood Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA., Eckerman A; Vascular Solutions LLC, Minneapolis, Minnesota, USA., Macdonald VW; US Army Medical Materiel Development Activity (USAMMDA), Ft. Detrick, Maryland, USA., L Charles M; Vascular Solutions LLC, Minneapolis, Minnesota, USA., Markstrom L; Vascular Solutions LLC, Minneapolis, Minnesota, USA., Atkinson AJ; US Army Medical Materiel Development Activity (USAMMDA), Ft. Detrick, Maryland, USA., King MR; Westat Inc., Rockville, Maryland, USA., Snyder M; Westat Inc., Rockville, Maryland, USA., Burgess D; Westat Inc., Rockville, Maryland, USA., Murto J; Vascular Solutions LLC, Minneapolis, Minnesota, USA., Valiyaveettil MK; US Army Medical Materiel Development Activity (USAMMDA), Ft. Detrick, Maryland, USA., C Pehta J; The Alpha Bio Group, New Canaan, Connecticut, USA., Penegor SA; Vascular Solutions LLC, Minneapolis, Minnesota, USA.
Jazyk: angličtina
Zdroj: Transfusion [Transfusion] 2022 Feb; Vol. 62 (2), pp. 406-417. Date of Electronic Publication: 2021 Dec 24.
DOI: 10.1111/trf.16756
Abstrakt: 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-blind with a cross-over arm that compared FDP versus FFP using descriptive analysis for AEs, coagulation, hematology, and chemistry parameters.
Results: FDP coagulation factors, clotting times, and product quality (pH, total protein, and osmolality) post-lyophilization were preserved. FDP infusions, of up to 810 ml per subject, were found to be safe and with no serious AEs (SAEs) related to FDP. The average time to reconstitute FDP was 67 s (range: 43-106). No differences in coagulation parameters or thrombin activation were detected in subjects infused with 810 ml of FDP compared with FFP.
Conclusion: This first next-generation FDP product preserves the potency and safety of FFP in a novel rugged, compressible, plastic container, for rapid transfusion, allowing rapid access to plasma in resuscitation protocols for therapy in acute traumatic hemorrhage.
(© 2021 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)
Databáze: MEDLINE
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