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 additive solution (PAS) III (InterSol) for 5 days.


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 2500cGy Day 1 gamma irradiation was evaluated in a subset of products.


RESULTS
PAS III PLTs (n=70) had a median Day 5 pH(22°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.


CONCLUSIONS
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.
Vassallo
Ralph R
RR
American Red Cross Blood Services, Penn-Jersey Region, Philadelphia, Pennsylvania 19123, USA. usa.redcross.org
Adamson
John W
JW
Gottschall
Jerome L
JL
Snyder
Edward L
EL
Lee
Wanda
W
Houghton
Jaime
J
Elfath
M Dean
MD
D000085:Acetates / Q000494:pharmacology; D001792:Blood Platelets / Q000187:drug effects / Q000528:radiation effects; D001793:Blood Preservation / Q000379:methods*; D001804:Blood Transfusion, Autologous / Q000379:methods; D002951:Citrates / Q000494:pharmacology; D005720:Gamma Rays; D006801:Humans; D066298:In Vitro Techniques; D010976:Platelet Count; D017713:Platelet Transfusion / Q000379:methods*; D053657:Platelet-Rich Plasma; D010983:Plateletpheresis / Q000379:methods*; D012996:Solutions / Q000494:pharmacology*
D000085:Acetates; D002951:Citrates; D012996:Solutions