1.
A pilot study to assess the hemostatic function of pathogen-reduced platelets in patients with thrombocytopenia
Johansson PI, Simonsen AC, Brown PN, Ostrowski SR, Deberdt L, Van Hoydonck P, Yonemura SS, Goodrich RP
Transfusion. 2013;53((9):):2043-52.
Abstract
BACKGROUND Platelet (PLT) support is critical to the care of patients with thrombocytopenia, but allogeneic transfusions carry risk. Pathogen reduction mitigates some transfusion risks, but effects on PLT function remain a concern. This clinical pilot study assessed the effect of pathogen reduction technology with riboflavin plus ultraviolet light using thrombelastography (TEG). STUDY DESIGN AND METHODS This prospective, randomized, crossover study compared Mirasol-treated (MIR) and standard reference (REF) PLT transfusions. PLT counts and TEG measurements were taken at pretransfusion and 1- and 24-hour-posttransfusion time points. The primary outcome measure was the pretransfusion to 1-hour-posttransfusion change in maximum amplitude (MA1hr ). Secondary endpoints included MA among other time points, relative MA, and the PLT count-MA correlation. RESULTS Of 16 enrolled patients, one withdrew before study treatment and three did not require two transfusions, leaving 12 patients in the efficacy analyses (seven MIR-REF, five REF-MIR). MA1hr (mean+/-SD) was 10.60+/-6.47mm for MIR and 14.33+/-5.38mm for REF (p=0.20, n=10). MA24hr was 9.49+/-7.94 for MIR and 7.13+/-3.08 for REF (p=0.38, n=9); MA24hr-1hr was -1.11+/-2.95 for MIR and -7.20+/-4.81 for REF (p=0.016, n=8). MA values for MIR and REF correlated with the log of PLT count (rMIR =0.6901, rREF =0.7399). CONCLUSION TEG is sensitive to changes in hemostatic function resulting from a single PLT transfusion. MIR and REF provided similar increments in hemostatic function in the immediate posttransfusion period and at 24 hours. A significant difference detected for MA24hr-1hr suggests different PLT clearance mechanisms. The relationship of these variables to clinically meaningful outcomes, for example, bleeding events or transfusion requirements, has yet to be determined. 2012 American Association of Blood Banks.
2.
Transfusion of 7-day-old amotosalen photochemically treated buffy-coat platelets to patients with thrombocytopenia: a pilot study
Simonsen AC, Johansson PI, Conlan MG, Jacquet M, Lin JS, Junge K, Lin L, Sørensen H, Borregaard N, Flament J
Transfusion. 2006;46((3):):424-33.
Abstract
BACKGROUND Photochemical treatment (PCT) of platelets (PLTs) with amotosalen and ultraviolet A light to inactivate bacteria may facilitate extension of storage from 5 to 7 days. STUDY DESIGN AND METHODS A randomized, double-blinded, crossover, noninferiority, single-site pilot study utilizing pooled buffy-coat PLTs was conducted. The primary endpoint was the 1-hour corrected count increment (CCI) after one transfusion each of 7-day-old PCT and reference (R) PLT components. Secondary endpoints included 1-hour count increment, time to next transfusion, hemostasis, transfusion reactions, and serious adverse events. RESULTS Twenty patients with thrombocytopenia were randomly assigned: 9 to the PCT-R sequence and 11 to the R-PCT sequence. A significant treatment-by-period interaction was observed. Therefore, the first period only was also analyzed for the primary endpoint. Including both treatment periods, mean 1-hour CCI was 6587 +/- 4531 for PCT versus 8935 +/- 5478 for R-PLTs. For the first period only, mean 1-hour CCI was 8739 +/- 3785 for PCT versus 7433 +/- 5408 for R-PLTs. The upper bound of the one-sided 95 percent confidence interval of 2400 for the mean difference was higher than the specified noninferiority margin of 2200 for both analyses. Overall median time to next transfusion was 22 hours for PCT versus 27 hours for R-PLTs. Hemostasis was adequate and no transfusion reactions or serious adverse events were reported. CONCLUSIONS Although this pilot study of a limited number of patients failed to show noninferiority within the specified noninferiority margin, 7-day-old PCT PLTs showed acceptable efficacy and safety for support of thrombocytopenia. The results, however, warrant evaluation in a larger trial of 7-day-old PCT PLTs.