Revisiting study design and methodology for pathogen reduced platelet transfusions: a round table discussion.

Abstract:

:Pathogen inactivation/reduction technologies for platelet components have been developed to enhance microbial safety, and many studies have been carried out to determine whether this technique adversely affects the platelet's ability to stop or prevent bleeding. These clinical trials require inclusion of several hundred patients, are costly, and take many years to complete. To address these challenges, a meeting was organized consisting of two expert presentations followed by a roundtable discussion focused on possible new approaches to evaluate the clinical efficacy of pathogen-reduced platelets. The value of laboratory measures to provide information on platelet count after transfusion or to serve as a surrogate for bleeding risk was discussed. Also, other types of trial designs (cluster trials, stepped wedge designs, and Phase 4 postmarketing surveillance studies) as well as a clinically meaningful standardized safety endpoint to evaluate pathogen- reduced platelets were also discussed.

journal_name

Transfusion

journal_title

Transfusion

authors

Heddle NM,Cardoso M,van der Meer PF

doi

10.1111/trf.15779

subject

Has Abstract

pub_date

2020-07-01 00:00:00

pages

1604-1611

issue

7

eissn

0041-1132

issn

1537-2995

journal_volume

60

pub_type

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