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Abstract

Biotherapies, Cellular Therapies, and Immunotherapies

Oral Abstract - Platelet Storage

OA3-AM24-MN-14 - Comparative Analysis of Room Temperature (RT) Day 7 and Cold Storage (CS) Day 21 Platelets: An Interim Evaluation of the Chilled Platelet Study in vitro (CHIPSiv)

Monday, October 21, 2024
9:45 AM - 10:45 AM  
Location: 332
CE: Zero
Background/Case Studies: Platelet (PLT) transfusions vital for trauma, surgery, thrombocytopenia; crucial for hemostasis in acute bleeding or prophylaxis. Storage of platelets imparts a lesion which deteriorates product quality and hemostatic capacity over time. Cold storage (2-6°C) of apheresis PLT products preserves platelet metabolism and hemostatic function and offers a potential solution to extend product shelf life. The ongoing Chilled Platelet Study trial (NCT04834414) includes an extensive in vitro arm (CHIPSiv) investigating PLT quality metrics of differentially manufactured platelet products. As part of this study, we present an interim analysis evaluating the biochemical and hemostatic profiles of Day 7 room temperature-stored and Day 21 cold-stored platelets with baseline Day 0.

Study

Design/Methods:

Apheresis PLT were collected using the Trima Accel 7 (N=14 in plasma and N=18 in PAS) or the Amicus (N=14 plasma, N=15 PAS). Complete blood counts, biochemistry, and hemostatic function were analyzed. Statistical analysis utilized multiple comparisons tests, focusing on baseline D0 versus RT-D7 versus CS-D21. Correlations between laboratory parameters were evaluated using the Spearman rank correlation coefficient. For this interim analysis, all units were analyzed together with respect to their baseline to determine the impact of temperature.

Results/Findings:

 Glucose, pH, and lactate levels were comparable between RT-D7 and CS-D21. Aggregation ability in response to dual agonists (ADP + Epinephrine and ADP + collagen) showed no significant difference between both groups compared with D0. Thrombin generation was comparable between RT-D7 and CS-D21. Both groups exhibited a significant decrease in maximum clot firmness (MCF) in ROTEM EXTEM analysis compared to baseline, with no difference between RT-D7 and CS-D21 for the FIBTEM MCF. Interestingly, PLT hematology parameters such as count, mean PLT volume (MPV), platelet diversity index (PDW), and plateletcrit (PCT) decreased in the CS-D21 group, while the presence of larger PLT (P-LCRs platelet larger cell ratio) and PLT dry mass distribution width (PMDW) showed no difference between RT-D7 and CS-D21. CS-D21 platelet count was negatively correlated with bicarbonate (HCO3), dual agonist aggregometry, and pH, whereas these correlations were absent in RT-Day 7 platelets (Figure A).

Conclusions:

Considering the biochemical parameters, platelet aggregation, and thrombin generation capacity of CS-PLT, in vitro data suggests extending the platelet shelf-life up to 21 days might be feasible in resource-constrained settings. Future research will explore platform-specific storage performance analyses which can be considered for licensing criteria of cold storage platelet.