Hemostatic efficacy of pathogen-inactivated vs untreated platelets: a randomized controlled trial.

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  • Additional Information
    • Source:
      Publisher: Elsevier Country of Publication: United States NLM ID: 7603509 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1528-0020 (Electronic) Linking ISSN: 00064971 NLM ISO Abbreviation: Blood Subsets: MEDLINE
    • Publication Information:
      Publication: 2021- : [New York] : Elsevier
      Original Publication: New York, Grune & Stratton [etc.]
    • Subject Terms:
      Hemostasis* ; Platelet Transfusion*/adverse effects ; Platelet Transfusion*/methods; Blood Platelets/*metabolism; Blood Coagulation ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Multicenter Studies as Topic ; Patient Outcome Assessment ; Platelet Function Tests ; Randomized Controlled Trials as Topic
    • Abstract:
      Pathogen inactivation of platelet concentrates reduces the risk for blood-borne infections. However, its effect on platelet function and hemostatic efficacy of transfusion is unclear. We conducted a randomized noninferiority trial comparing the efficacy of pathogen-inactivated platelets using riboflavin and UV B illumination technology (intervention) compared with standard plasma-stored platelets (control) for the prevention of bleeding in patients with hematologic malignancies and thrombocytopenia. The primary outcome parameter was the proportion of transfusion-treatment periods in which the patient had grade 2 or higher bleeding, as defined by World Health Organization criteria. Between November 2010 and April 2016, 469 unique patients were randomized to 567 transfusion-treatment periods (283 in the control arm, 284 in the intervention arm). There was a 3% absolute difference in grade 2 or higher bleeding in the intention-to-treat analysis: 51% of the transfusion-treatment periods in the control arm and 54% in the intervention arm (95% confidence interval [CI], -6 to 11; P = .012 for noninferiority). However, in the per-protocol analysis, the difference in grade 2 or higher bleeding was 8%: 44% in the control arm and 52% in the intervention arm (95% CI -2 to 18; P = .19 for noninferiority). Transfusion increment parameters were ∼50% lower in the intervention arm. There was no difference in the proportion of patients developing HLA class I alloantibodies. In conclusion, the noninferiority criterion for pathogen-inactivated platelets was met in the intention-to-treat analysis. This finding was not demonstrated in the per-protocol analysis. This trial was registered at The Netherlands National Trial Registry as #NTR2106 and at www.clinicaltrials.gov as #NCT02783313.
      (© 2018 by The American Society of Hematology.)
    • Comments:
      Comment in: Blood. 2018 Jul 12;132(2):119-121. (PMID: 30002047)
    • Molecular Sequence:
      ClinicalTrials.gov NCT02783313
      NTR NTR2106
    • Publication Date:
      Date Created: 20180519 Date Completed: 20190709 Latest Revision: 20210202
    • Publication Date:
      20221213
    • Accession Number:
      10.1182/blood-2018-02-831289
    • Accession Number:
      29773572