P‐BB‐5 | A New Thermoregulated Container System for Cold Processing of Whole Blood Donations in Extreme Climate Conditions
Notice bibliographique
Résumé
Per Canadian quality standards, the internal temperature of whole blood (WB) must reach 10°C ≤24 h 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 h 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 h post-donation in extreme climatic conditions (−30°C to 40°C). 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 h 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. The ICE-PE and PCM5 were stored in VIP containers for up to 48 h under extreme climatic conditions before use. They maintained their thermoregulating properties and enabled WBD to be transported over a 24-h 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 (<08% 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. TCS cooling materials can be stored in VIP containers for up to 48 h before use. The TCS described here can therefore be used in extreme climatic conditions to transport WBD for up to 24 h without impacting product quality, thereby providing critical operational flexibility to maintain blood bank inventory levels.
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Prédiction distillée sur la base complète
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Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
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