(P-BC-16) Comparison of Automated-Whole-Blood-Processing Derived Pathogen-Reduced Platelets with Apheresis Pathogen-Reduced Platelets

Background/Case Studies: Automated whole-blood processing was introduced in 2018 in our center to facilitate the production workflow and increase product uniformity. To mitigate infectious risk, the automated production process was adjusted for compatibility with amotosalen/UVA pathogen reduction (PR). In all our platelet units 53-68% of the plasma is replaced by PAS to reduce the risk of transfusion reactions (TRALI, allergic reactions, other). Aim of the study is the comparison of quality markers of PR-apheresis platelet concentrates (APCs) and automated whole-blood processing derived, PR-pooled platelet concentrates (PPCs) in 53-68% PAS.

Study

Design/Methods: CPD whole blood (average 470 mL) was collected from voluntary donors. Units were processed immediately or after O/N storage using the automated Reveos device (Terumo BCT). Five ABO-identical intermediate platelet units (IPUs) with a target volume of 35 mL each were pooled with 200 mL PAS (T-PAS+, Terumo BCT). Apheresis platelets were collected with a Trima Accel (Terumo) or MCS+ (Haemonetics) device in 53-68% Intersol (Fresenius Kabi). All PCs were pathogen-reduced with amotosalen/UVA (INTERCEPT Blood System, Cerus). The WBC count was assessed with an ADAM-rWBC Analyzer (NanoEnTek Inc.), the platelet count with a DxH 900 or 690T (Beckman Coulter) and the pH with a HI 2212 pH-meter (Hanna Insturments). Blood culture was assessed with a BacT/Alert 3D system (Biomerieux), sampling 8-10 mL per culture bottle. Results are reported as mean ± standard deviation, the p-value was determined with the two-sample t-test.

Results/Findings: In 2023, 13928 PCs were produced (67.5% PR-APCs and 32.5% PR-PPCs), in 2024 14807 PCs were produced (72.2% PR-APCs and 27.8% PR-PPCs). The reduced share of PPCs in 2024 compared to 2023 correlates with a 17.5% reduction of whole blood collections. The average discard rate of IPUs pre-pooling and pre-PR was 20.0% ± 2.2 (reasons: quality, ABO group, positive infectious diseases tests, other). Four units per month per platelet type were sampled 2023 and 2024 for quality control (n=48 per year per PC type) at day 2-3 of storage. The mean PR-APCs platelet dose (3.7 x 10¹¹± 0.4) and concentration (1116.5 x 10⁹/mL ± 111) in 2023/2024 was significantly higher compared to PR-PPCs (3.4 x 10¹¹ ± 0.4) and (982.11 x 10⁹/mL ± 127.66) (p< 0.001 for both). The mean pH of PR-APCs (6.7 ± 0.2) and PR-PPCs (6.7 ± 0.2) as well as the mean WBC count (0.3 x 10⁶ ± 0.2 and 0.3 x 10⁶ ± 0.4) were not significantly different (p >0.05). All PR-treated units were blood culture negative.

Conclusions: Automated, whole-blood processing derived PR-PPCs were not significantly different in quality from APCs, the platelet dose per unit was in average 8.1% lower in PPCs. All units met local and AABB guideline requirements