title: Clinical effectiveness of leucoreduced, pooled donor platelet concentrates, stored in plasma or additive solution with and without pathogen reduction.
abstract: Pathogen reduction (PR) of platelet products increases costs and available clinical studies are equivocal with respect to clinical and haemostatic effectiveness. We conducted a multicentre, open-label, randomized, non-inferiority trial comparing the clinical effectiveness of buffy-coat derived leukoreduced platelet concentrates (PC) stored for up to 7 d in plasma with platelets stored in platelet additive solution III (PASIII) without and with treatment with amotosalen-HCl/ultraviolet-A (UVA) photochemical pathogen reduction (PR-PASIII). Primary endpoint of the study was 1-h corrected count increment (CCI). Secondary endpoints were 24-h CCI, bleeding, transfusion requirement of red cells and PC, platelet transfusion interval and adverse transfusion reactions. Compared to plasma-PC, in the intention to treat analysis of 278 evaluable patients the mean difference for the 1-h CCI of PR-PASIII-PC and PASIII-PC was -31% (P < 0.0001) and -9% (P = n.s.), respectively. Twenty-seven patients (32%) had bleeding events in the PR-PASIII arm, as compared to 19 (19%) in the plasma arm and 14 (15%) in the PASIII arm (P = 0.034). Despite the potential advantages of pathogen (and leucocyte) inactivation of amotosalen-HCl/UVA-treated platelet products, their clinical efficacy is inferior to platelets stored in plasma, warranting a critical reappraisal of employing this technique for clinical use.
authors.affiliation: Sanquin Blood Bank, Southwest Region, Rotterdam, The Netherlands. j.kerkhoffs@sanquin.nl
authors.forename: Jean-Louis H
authors.initials: JL
authors.lastname: Kerkhoffs
authors.forename: Wim L J
authors.initials: WL
authors.lastname: van Putten
authors.forename: Viera M J
authors.initials: VM
authors.lastname: Novotny
authors.forename: Peter A W
authors.initials: PA
authors.lastname: Te Boekhorst
authors.forename: Martin R
authors.initials: MR
authors.lastname: Schipperus
authors.forename: Jaap Jan
authors.initials: JJ
authors.lastname: Zwaginga
authors.forename: Lizzy C M
authors.initials: LC
authors.lastname: van Pampus
authors.forename: Georgine E
authors.initials: GE
authors.lastname: de Greef
authors.forename: Marleen
authors.initials: M
authors.lastname: Luten
authors.forename: Peter C
authors.initials: PC
authors.lastname: Huijgens
authors.forename: Anneke
authors.initials: A
authors.lastname: Brand
authors.forename: Dick J
authors.initials: DJ
authors.lastname: van Rhenen
mesh_terms: D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000517:prevention & control / Q000635:transmission; D001792:Blood Platelets / Q000382:microbiology*; D001793:Blood Preservation / Q000379:methods*; D005260:Female; D011564:Furocoumarins; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D047589:Leukocyte Reduction Procedures / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010949:Plasma; D017713:Platelet Transfusion / Q000009:adverse effects / Q000379:methods*; D013921:Thrombocytopenia / Q000628:therapy*; D016896:Treatment Outcome; D014466:Ultraviolet Rays; D014777:Virus Diseases / Q000517:prevention & control / Q000635:transmission
chemical_list: D011564:Furocoumarins; C118577:amotosalen