The role of hemovigilance and postmarketing studies when introducing innovation into transfusion medicine practice: the amotosalen‐ultraviolet A pathogen reduction treatment model

Abstract

Although inherently different from RCTs, properly designed postmarketing studies are informative regarding the safety and efficacy of innovative transfusion technologies in large patient populations under conditions of routine use.

Patient outcomes and amotosalen/UVA‐treated platelet utilization in massively transfused patients

“…Amotosalen/UVA‐treated PCs have demonstrated efficacy for treatment and prevention of bleeding in large randomized controlled clinical trials . Efficacy and safety were confirmed under routine‐use conditions, as reported to large national haemovigilance programmes and in industry‐sponsored postmarketing comparative effectiveness studies .…”

Enlargement of the WHO international repository for platelet transfusion‐relevant bacteria reference strains

“…Routine‐use and clinical outcome studies of rapid bacterial detection systems performed on the day of transfusion have been published, including studies using lateral flow immunoassays , colorimetric assays , flow cytometry and PCR . PR systems offer an alternative to microbiological detection methods and haemovigilance data support their effectiveness .…”

How do we … integrate pathogen reduced platelets into our hospital blood bank inventory?

“…Similarly, data on product usage per patient are necessary to document the efficacy of PR PLTs. Data addressing these points have been published by our group [37][38][39] and others [19][20][21][22][23][24][34][35][36]40 providing evidence supporting the concept that diminishing the infectious risk by crosslinking nucleic acids does not negatively impact PLT activation or hemostatic efficacy. Other studies, however, including the EFFIPAP trial have also addressed this issue.…”

“…7 Several publications, however, have shown no association between development of ARDS and infusion of PR PLTs. [33][34][35][36] Based on these data, our institution decided that the risk of bacterial septic reactions from conventional PLTs outweighed the potential risk of respiratory complications from PR PLTs. To further address the risk of ARDS from PR PLT products, an FDA-mandated Phase IV clinical trial comparing PR versus conventional PLTs (PIPER) has been initiated.…”