Results of clinical effectiveness of conventional versus Mirasol-treated Apheresis Platelets in Patients with Hypoproliferative Thrombocytopenia (MiPLATE) trial

被引：5

作者：

Koepsell, Scott A. ^{[1
]}

Stolla, Moritz ^{[2
]}

Sedjo, Rebecca L. ^{[3
]}

Carson, Jeffrey ^{[4
]}

Knudson, Michael ^{[5
]}

Cook, Richard ^{[6
]}

Fasano, Ross ^{[7
]}

Ngamsuntikul, Samantha G. ^{[8
]}

Cohn, Claudia ^{[9
]}

Gorlin, Jed ^{[10
]}

Delaney, Meghan ^{[11
,12
]}

Slichter, Sherrill ^{[2
]}

Ness, Paul ^{[13
]}

McCullough, Jeffrey ^{[9
]}

机构：

[1] Univ Nebraska Med Ctr, Dept Pathol & Microbiol, Omaha, NE 68198 USA

[2] Univ Washington, Dept Med, Div Hematol, Seattle, WA USA

[3] Terumo BCT Inc, Clin Res & Dev, Lakewood, CO USA

[4] Univ Med & Dent New Jersey, Dept Med, New Brunswick, NJ USA

[5] Univ Iowa, Carver Coll Med, Dept Pathol, Iowa City, IA USA

[6] Lifetime Sci Inc, Waterloo, ON, Canada

[7] Emory Univ, Sch Med, Dept Pathol & Lab Med, Ctr Transfus & Cellular Therapies, Atlanta, GA USA

[8] South Texas Blood & Tissue, San Antonio, TX USA

[9] Univ Minnesota, Lab Med & Pathol, Minneapolis, MN USA

[10] Mem Blood Ctr MN, Minneapolis, MN USA

[11] Childrens Natl Hosp, Dept Pathol, Washington, DC USA

[12] George Washington Univ, Sch Med, Washington, DC USA

[13] Johns Hopkins Univ, Dept Pathol, Baltimore, MD USA

来源：

TRANSFUSION | 2024年 / 64卷 / 03期

关键词：

hematology; platelets; platelet transfusion; transfusion-transmitted disease; PATHOGEN INACTIVATION; THERAPEUTIC-EFFICACY; ADDITIVE SOLUTION; SAFETY; PLASMA; ULTRAVIOLET; RIBOFLAVIN; TRANSFUSION;

D O I：

10.1111/trf.17720

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: The Mirasol (R) Pathogen Reduction Technology System was developed to reduce transfusion-transmitted diseases in platelet (PLT) products. Study design and methods: MiPLATE trial was a prospective, multicenter, controlled, randomized, non-inferiority (NI) study of the clinical effectiveness of conventional versus Mirasol-treated Apheresis PLTs in participants with hypoproliferative thrombocytopenia. The novel primary endpoint was days of >= Grade 2 bleeding with an NI margin of 1.6. Results: After 330 participants were randomized, a planned interim analysis of 297 participants (145 MIRASOL, 152 CONTROL) receiving >= 1 study transfusion found a 2.79-relative rate (RR) in the MIRASOL compared to the CONTROL in number of days with >= Grade 2 bleeding (95% confidence interval [CI] 1.67-4.67). The proportion of subjects with >= Grade 2 bleeding was 40.0% (n = 58) in MIRASOL and 30.3% (n = 46) in CONTROL (RR = 1.32, 95% CI 0.97-1.81, p = .08). Corrected count increments were lower (p < .01) and the number of PLT transfusion episodes per participant was higher (RR = 1.22, 95% CI 1.05-1.41) in MIRASOL. There was no difference in the days of PLT support (hazard ratio = 0.86, 95% CI 0.68-1.08) or total number of red blood cell transfusions (RR = 1.12, 95% CI 0.91-1.37) between MIRASOL versus CONTROL. Transfusion emergent adverse events were reported in 119 MIRASOL participants (84.4%) compared to 133 (82.6%) participants in CONTROL (p = NS). Discussion: This study did not support that MIRASOL was non-inferior compared to conventional platelets using the novel endpoint number of days with >= Grade 2 bleeding in MIRASOL when compared to CONTROL.

引用

页码：457 / 465

页数：9