In vitro and in vivo evaluation of apheresis platelets stored for 5 days in 65% platelet additive solution/35% plasma

BACKGROUND: In the United States, apheresis platelets (PLTs) are suspended in autologous plasma. PLT additive solutions, long used in Europe, decrease recipient allergic reactions and may reduce the risk of transfusion‐related acute lung injury. We evaluated Amicus‐collected PLTs stored in platelet...

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Veröffentlicht in:Transfusion (Philadelphia, Pa.) Jg. 50; H. 11; S. 2376 - 2385
Hauptverfasser: Vassallo, Ralph R., Adamson, John W., Gottschall, Jerome L., Snyder, Edward L., Lee, Wanda, Houghton, Jaime, Elfath, M. Dean
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Malden, USA Blackwell Publishing Inc 01.11.2010
Wiley
Schlagworte:
Acetates - pharmacology
Additives
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Biological and medical sciences
Blood coagulation. Blood cells
Blood Platelets - drug effects
Blood Platelets - radiation effects
Blood Preservation - methods
Blood Transfusion, Autologous - methods
Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis
Citrates - pharmacology
Fundamental and applied biological sciences. Psychology
Gamma Rays
Humans
In Vitro Techniques
Injuries
Lung
Medical sciences
Molecular and cellular biology
Platelet
Platelet Count
Platelet Transfusion - methods
Platelet-Rich Plasma
Plateletpheresis - methods
risk reduction
Solutions - pharmacology
Transfusions. Complications. Transfusion reactions. Cell and gene therapy
USA
Europe
Platelet
Transfusion
Apheresis
Conservation
ISSN:0041-1132, 1537-2995, 1537-2995
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Zusammenfassung:BACKGROUND: In the United States, apheresis platelets (PLTs) are suspended in autologous plasma. PLT additive solutions, long used in Europe, decrease recipient allergic reactions and may reduce the risk of transfusion‐related acute lung injury. We evaluated Amicus‐collected PLTs stored in platelet additive solution (PAS) III (InterSol) for 5 days. STUDY DESIGN AND METHODS: In Study 1, 71 subjects donated two products on a single day—one each stored in 100% plasma or 65% PAS III/35% plasma. Products underwent standard in vitro testing on Days 1 and 5. In Study 2, 43 additional subjects provided Amicus products stored for 5 days in 65% PAS III/35% plasma for in vivo radiolabeled recovery and survival determinations. The effect of approximately 2500 cGy Day 1 gamma irradiation was evaluated in a subset of products. RESULTS: PAS III PLTs (n = 70) had a median Day 5 pH22°C of 7.2 (lower 95%, 95% tolerance limit, 6.9). Mean Day 5 recovery and survival of radiolabeled PAS III PLTs (n = 33) were, respectively, 80.5 and 72.1%, of fresh autologous PLTs. With 95% confidence, these values were at least 66% of fresh PLT recovery and 58% of survival. All in vitro variables remained within ranges seen in licensed products for irradiated and nonirradiated PAS III PLTs. CONCLUSION: Leukoreduced Amicus PLTs stored in 65% PAS III/35% plasma in PL‐2410 containers maintained pH ≥ 6.9 throughout 5 days' storage. Radiolabeled PLT recovery and survival values met US Food and Drug Administration statistical criteria. Gamma‐irradiated PAS III PLTs demonstrated no significant adverse effects due to irradiation in in vitro testing.
Bibliographie:istex:FBBCBC272F39B66F07025CDBFD4F303250A94E96
ArticleID:TRF2693
ark:/67375/WNG-3RDFJLQK-3
Deceased.
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ISSN:0041-1132
1537-2995
1537-2995
DOI:10.1111/j.1537-2995.2010.02693.x