A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology.

Details

Serval ID
serval:BIB_10A1D0ECF464
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology.
Journal
Transfusion
Working group(s)
Mirasol Clinical Evaluation Study Group
Contributor(s)
Cazenave JP., Folléa G., Bardiaux L., Boiron JM., Lafeuillade B., Debost M., Lioure B., Harousseau JL., Deconinck E., Tabrizi R., Cahn JY., Michallet M., Ambruso D., Tissot JD., Sensebé L., Kondo T., McCullough J., Rebulla P., Escolar G., Mintz P., Heddle NM., Goodrich RP., Bruhwyler J., Le C., Cook RJ., Stouch B., Fletcher D., Deberdt L.
ISSN
1537-2995 (Electronic)
ISSN-L
0041-1132
Publication state
Published
Issued date
2010
Peer-reviewed
Oui
Volume
50
Number
11
Pages
2362-2375
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: ppublish
Abstract
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 (CCI(1hour) ) 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 CCI(1hour) 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-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).
CONCLUSION: 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.
Keywords
Adult, Aged, Bacterial Infections/prevention & control, Blood Platelets/drug effects, Blood Platelets/radiation effects, Blood Preservation/adverse effects, Blood Preservation/methods, Female, Follow-Up Studies, Hematologic Neoplasms/complications, Hemorrhage/etiology, Humans, Male, Middle Aged, Platelet Count, Platelet Transfusion/adverse effects, Platelet Transfusion/methods, Riboflavin/adverse effects, Riboflavin/pharmacology, Thrombocytopenia/etiology, Thrombocytopenia/therapy, Treatment Outcome, Ultraviolet Rays, Young Adult
Pubmed
Web of science
Create date
16/01/2012 15:16
Last modification date
20/08/2019 12:37
Usage data