(P-BC-62) The Importance of Temperature Control of Collection Sets Used for the Production of Platelets from Whole Blood and Effects on Platelet Yield

Whole Blood (WB) can be componentized into red cells, platelets, and plasma, manually or via automated processing. For WB units intended for platelet separation, the US Code of Federal Regulations [21 eCFR 640.24] requires that WB is held between 20 and 24°C immediately after collection until the platelets are separated and yield a minimum of 5.5 × 10¹⁰ platelets in at least 75% of units. Additionally, investigational studies demonstrated the importance of temperature control of the sets prior to use in the collection of WB to achieve requisite platelet yield.

Study

Design/Methods:

WB was separated into components using the Reveos™ Automated Blood Processing System (Terumo BCT, Inc., Lakewood, CO). Blood was processed 2 - 8 hours after collection into investigational Reveos sets (Terumo BCT, Inc.) containing CPD anticoagulant. Collection sets were kept at either 18°C or 22°C immediately prior to WB collection. After collection, WB units were transported to the laboratory and held at 22°C until componentization. The resulting platelet units were evaluated for platelet yield, with a target of ≥ 75% of units containing ≥ 5.5 x10¹⁰ platelets to meet the FDA requirement.

Results/Findings:

Table 1 shows the impact of WB collection set temperature on whole blood derived platelet (WBDP) yield. Data (not shown) demonstrate that, over time, collection set temperature equilibrates to ambient room temperature. When the temperature of the collection sets at time of use was increased from 18 to 22°C, mean platelet yield increased by 31.8% (p = 0.019 in a two-sample t-test). The success rate of platelet yield ≥ 5.5 x10¹⁰ increased from 74.3 to 94.1%.

Conclusions:

Maintaining WB temperature at 20 - 24⁰C from collection to componentization is crucial for achieving acceptable platelet yields in WBDP. Per the Reveos SELECT set Instructions for Use (IFU), the temperature range for long-term storage of collection sets is 1 - 30⁰C. However, compared to colder temperatures, collection sets brought to 22⁰C prior to WB collection significantly increased platelet yield.