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

被引：134

作者：

Cazenave, J. -P ^{[1
]}

Follea, G. ^{[1
]}

Bardiaux, L. ^{[1
]}

Boiron, J. -M. ^{[1
]}

Lafeuillade, B. ^{[1
]}

Debost, M. ^{[1
]}

Lioure, B. ^{[1
]}

Harousseau, J. -L. ^{[1
]}

Tabrizi, R. ^{[1
]}

Cahn, J. -Y ^{[1
]}

Michallet, M. ^{[1
]}

Ambruso, D. ^{[1
]}

Schots, R. ^{[1
]}

Tissot, J. -D. ^{[1
]}

Sensebe, L. ^{[1
]}

Kondo, T. ^{[1
]}

McCullough, J. ^{[1
]}

Rebulla, P. ^{[1
]}

Escolar, G. ^{[1
]}

Mintz, P. ^{[1
]}

Heddle, N. M. ^{[1
]}

Goodrich, R. P. ^{[1
]}

Bruhwyler, J. ^{[1
]}

Le, C. ^{[1
]}

Cook, R. J. ^{[1
]}

Stouch, B. ^{[1
]}

机构：

[1] CaridianBCT Biotechnol LLC, Lakewood, CO 80215 USA

来源：

TRANSFUSION | 2010年 / 50卷 / 11期

关键词：

WHITE BLOOD-CELLS; PHOTOCHEMICAL INACTIVATION; BACTERIAL-CONTAMINATION; ULTRAVIOLET-LIGHT; PRT TREATMENT; RIBOFLAVIN; PLASMA; APHERESIS; PHOTOINACTIVATION; CRYOPRESERVATION;

D O I：

10.1111/j.1537-2995.2010.02694.x

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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, Candian-BCT 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-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

引用

页码：2362 / 2375

页数：14

共 50 条

[1]

Ambruso DR, 2009, TRANSFUSION, V49, p9A

[2] Platelet transfusion: Products, indications, dose, threshold and efficacy [J].