Background/Case Studies: Per Canadian quality standards, the internal temperature of whole blood (WB) must reach 10°C ≤ 24 hours post-donation and be maintained at 1–10°C until processing. However, complying with this standard can be difficult for WB donations (WBD) collected at blood drives >8 hours away from a processing center. Thermoregulated container systems (TCSs) are essential to adequately store WBD in the extreme climatic conditions encountered in Québec (Canada). The aims were to develop and validate a TCS that can maintain the temperature of WBD at 1–10 °C for up to 24 hours post donation in extreme climatic conditions (-30°C to 40°C).
Study
Design/Methods: The TCS consisted of an inner cage made of vacuum insulation panels (VIP); a water-based cooling material wrapped in a polyethylene foam (ICE-PE) that ensured moderate WB cooling; and multiple 5 °C phase changing materials (PCM5). In Phase 1, WB collection kits filled with 555 ml of a 0.9% saline solution at 30 °C mimicked fresh WBD, and internal temperature was monitored using thermal probes. In Phase 2, eighty WB units (each containing 450–550 mL) were collected. The WB units were shipped to the processing center in the TCSs within 24 hours of collection. Both real and controlled environments were tested to reproduce extreme winter (-30°C) and summer (+40°C) conditions. Various quality parameters (e.g., residual white blood cell [rWBC] count, hemolysis rate of red blood cell concentrates [RCCs], and Factor VIII [FVIII] in plasma) were measured.
Results/Findings: The ICE-PE and PCM5 were stored in VIP containers for up to 48 hours under extreme climatic conditions before use. They maintained their thermoregulating properties and enabled WBD to be transported over a 24-hour period in compliance with Canadian quality standards. At day 42 post-collection, the mean ± standard deviation (min–max) RCC hemolysis rate was 0.2±0.1 % (0.1–0.9%), and 79 of the 80 WBD (99%) complied with current hemolysis standards (< 0.8% for 90% of tested product). All RCCs met the current criterion of < 5×106 rWBC/unit. As expected, FVIII recovery was lower in extreme winter conditions (i.e., mean of 0.6±0.3 IU/mL [0.3–1.1 IU/mL]) than normal conditions (0.8±0.3 IU/mL [0.3–1.7 IU/mL]). FVIII recovery was particularly low for products obtained from WBD that approached the freezing point during transport, but >75% of WBD had ≥0.52 IU/mL in all conditions tested and thus met current quality standards. Conclusions: TCS cooling materials can be stored in VIP containers for up to 48 hours before use. The TCS described here can therefore be used in extreme climatic conditions to transport WBD for up to 24 hours without impacting product quality, thereby providing critical operational flexibility to maintain blood bank inventory levels.
Importance of research: This research project led to the development and the validation of a thermoregulated container system for the cooling and maintain of whole blood donations at T = [1-10°C] in a wide range of external climatic conditions (-30°C to 40°C). The passive system can be used for blood collection activities taking place over two consecutive days.
