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- Title
A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology
- Authors
Cazenave, J-P.; Folléa, G.; Bardiaux, L.; Boiron, J.-M.; Lafeuillade, B.; Debost, M.; Lioure, B.; Harousseau, J-L.; Tabrizi, R.; Cahn, J.-Y.; Michallet, M.; Ambruso, D.; Schots, R.; Tissot, J.-D.; Sensebé, L.; Kondo, T.; McCullough, J.; Rebulla, Paolo; Escolar, Gines; Mintz, P.
- Abstract
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 (CCI) as the primary outcome. 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 CCI determined using up to the first eight on-protocol PLT transfusions given during the treatment period. A total of 118 patients were randomly assigned (60 to PRT-PLTs; 58 to reference). Four patients per group did not require PLT transfusions leaving 110 patients in the analysis (56 PRT-PLTs; 54 reference). A total of 541 on-protocol PLT transfusions were given (303 PRT-PLTs; 238 reference). The least square mean CCI was 11,725 (standard error [SE], 1.140) for PRT-PLTs and 16,939 (SE, 1.149) for the reference group (difference, −5214; 95% confidence interval, −7542 to −2887; p < 0.0001 for a test of the null hypothesis of no difference between the two groups). The study failed to show noninferiority of PRT-PLTs based on predefined CCI criteria. PLT and red blood cell utilization in the two groups was not significantly different suggesting that the slightly lower CCIs (PRT-PLTs) did not increase blood product utilization. Safety data showed similar findings in the two groups. Further studies are required to determine if the lower CCI observed with PRT-PLTs translates into an increased risk of bleeding.
- Subjects
CLINICAL trials; MEDICAL research; BLOOD platelet examination; THROMBOCYTOPENIA; ULTRAVIOLET radiation; BLOOD platelet disorders
- Publication
Transfusion, 2010, Vol 50, Issue 11, p2362
- ISSN
0041-1132
- Publication type
Article
- DOI
10.1111/j.1537-2995.2010.02694.x