作者
J‐P Cazenave, G Follea, L Bardiaux, J‐M Boiron, B Lafeuillade, M Debost, B Lioure, J‐L Harousseau, R Tabrizi, J‐Y Cahn, M Michallet, D Ambruso, R Schots, J‐D Tissot, L Sensebé, T Kondo, J McCullough, Paolo Rebulla, Gines Escolar, P Mintz, NM Heddle, RP Goodrich, J Bruhwyler, C Le, RJ Cook, B Stouch, members of the The Mirasol Clinical Evaluation Study Group
发表日期
2010/11
期刊
Transfusion
卷号
50
期号
11
页码范围
2362-2375
出版商
Blackwell Publishing Inc
简介
BACKGROUND: Pathogen reduction of platelets (PRT‐PLTs) using riboflavin and ultraviolet light treatment has undergone Phase 1 and 2 studies examining efficacy and safety. This randomized controlled clinical trial (RCT) assessed the efficacy and safety of PRT‐PLTs using the 1‐hour corrected count increment (CCI1hour) as the primary outcome.
STUDY DESIGN AND METHODS: A noninferiority RCT was performed where patients with chemotherapy‐induced thrombocytopenia (six centers) were randomly allocated to receive PRT‐PLTs (Mirasol PRT, CaridianBCT Biotechnologies) or reference platelet (PLT) products. The treatment period was 28 days followed by a 28‐day follow‐up (safety) period. The primary outcome was the CCI1hour determined using up to the first eight on‐protocol PLT transfusions given during the treatment period.
RESULTS: A total of 118 patients were randomly assigned (60 to PRT …
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