Novel anticoagulant‐preservative solution maintained the hemostatic function of cold stored whole blood for 56 days

Whole blood (WB) is an efficient product for field medical resuscitation because of its unitary composition, tolerance for storage on ice and in field refrigerators, and simplicity of use. We measured quality parameters of a novel 8-week WB storage system. Here, 500 mL of WB from healthy donors was collected in 70 mL of CPDA-1, leukoreduced with a platelet-sparing filter, pooled into ABO-compatible two-unit pools, and split into matched pairs of equal volume designated as Test or Control units. Test units received an additional 50 mL of a novel WB preservative solution (APEX units, Hemerus Medical, St Paul, MN). A total of 15 paired WB units were evaluated at Day 0 (D0) and periodically up to Day 56 (D56) of storage at 1-6°C across two centers. Quality testing included cellularity, ATP concentrations, hemolysis, blood gases, metabolites, coagulation factor levels, thromboelastography (TEG), and bacterial culture. At D56, APEX units displayed higher RBC ATP concentration (3.14 vs. 2.18 μmol/gHb, p = 0.001), pH (6.53 vs. 6.50, p = 0.01), and higher bicarbonate reserve (8 vs. 5.4, p < 0.0001). D56 APEX units had greater platelet contribution to TEG clot strength (p < 0.01) and better preservation of red cell ATP (p < 0.001). Activities of fibrinogen, factor VIII, factor V, and protein S activity in APEX units remained within the reference levels on D56. No bacterial contamination was detected at the end of storage. These findings suggest that APEX preserves RBCs effectively and maintains platelet and plasma coagulation functions for up to 56 days.