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.
journal_name
Br J Haematoljournal_title
British journal of haematologyauthors
Kerkhoffs JL,van Putten WL,Novotny VM,Te Boekhorst PA,Schipperus MR,Zwaginga JJ,van Pampus LC,de Greef GE,Luten M,Huijgens PC,Brand A,van Rhenen DJ,Dutch - Belgian HOVON cooperative group.doi
10.1111/j.1365-2141.2010.08227.xsubject
Has Abstractpub_date
2010-07-01 00:00:00pages
209-17issue
2eissn
0007-1048issn
1365-2141pii
BJH8227journal_volume
150pub_type
杂志文章,多中心研究,随机对照试验abstract::We report the analysis of prognostic factors in a cohort of 660 patients entered in the first Medical Research Council trial in chronic lymphocytic leukaemia (CLL) between 1978 and 1984. The majority (94%) of patients were aged 50 or over and the number of men (M) was almost twice that of women (F) with an M:F ratio o...
journal_title:British journal of haematology
pub_type: 临床试验,杂志文章,随机对照试验
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