Next generation spray-dried on-demand plasma: A multicenter, randomized, dose-escalation, first-in-human safety study
Abstract
Background
Prehospital plasma transfusion for patients at risk of hemorrhagic shock reduces mortality, but cold-chain and logistical constraints limit product availability. This study reports the first-in-human clinical evaluation of a new spray-dried plasma product, Frontline On-Demand Plasma (ODP).
Methods
Twenty-four healthy volunteers were sequentially enrolled into three dose-escalation cohorts. Autologous apheresis plasma was processed into plasma frozen within 24 h (PF24), with half of each collection manufactured into ODP. Cohort 1 (n = 6) received 200 mL ODP; Cohort 2 (n = 6) received 400 mL; and Cohort 3 (n = 12) was a randomized, double-blind crossover comparing 800 mL ODP with 800 mL PF24. Subjects were monitored for 28 days after each infusion. The primary endpoint was treatment-emergent adverse events (TEAEs).
Results
System verification data demonstrated preservation of protein content in spray-dried plasma. All 24 participants completed the study and infusions were well tolerated. Thirty-five TEAEs occurred in 18 subjects; 34 were unrelated or unlikely related to infusion. In Cohort 3, TEAEs occurred at similar frequencies after ODP and PF24. Headache was the most common TEAE. Minor coagulation parameter changes were observed but were not clinically significant. Out-of-range coagulation values were evenly distributed between treatment groups.
Conclusions
Spray-dried plasma demonstrated a safety profile comparable to standard frozen plasma, with no thromboembolic events observed. Its durable plastic packaging and rapid reconstitution support its potential for widespread use in out-of-hospital care, including emergency and austere environments.