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Randomized Controlled Trial
. 2015 Jan;55(1):144-53.
doi: 10.1111/trf.12791. Epub 2014 Jul 28.

Transfusion-related adverse events in the Platelet Dose study

Affiliations
Randomized Controlled Trial

Transfusion-related adverse events in the Platelet Dose study

Richard M Kaufman et al. Transfusion. 2015 Jan.

Abstract

Background: How platelet (PLT) product characteristics such as dose, source (whole blood derived [WBD] vs. apheresis), storage duration, and ABO matching status affect the risks of transfusion-related adverse events (TRAEs) is unclear. Similarly, more information is needed to define how recipient characteristics affect the frequency of TRAEs after PLT transfusion.

Study design and methods: In the multicenter Platelet Dose ("PLADO") study, pediatric and adult hematology-oncology patients with hypoproliferative thrombocytopenia were randomized to receive low-dose (LD), medium-dose (MD), or high-dose (HD) PLT prophylaxis for a pretransfusion PLT count of not more than 10 × 10(9) /L. All PLT units (apheresis or WBD) were leukoreduced. Post hoc analyses of PLADO data were performed using multipredictor models.

Results: A total of 5034 PLT transfusions to 1102 patients were analyzed. A TRAE occurred with 501 PLT transfusions (10.0%). The most common TRAEs were fever (6.6% of transfusions), allergic or hypersensitivity reactions (1.9%), and sinus tachycardia (1.8%). Patients assigned HD PLTs were more likely than LD or MD patients to experience any TRAE (odds ratio for HD vs. MD, 1.50; 95% confidence interval, 1.10-2.05; three-group comparison p = 0.02). PLT source and ABO matching status were not significantly related to overall TRAE risk. Compared to a patient's first PLT transfusion, subsequent PLT transfusions were less likely to have a TRAE reported, primarily due to a lower risk of allergic or hypersensitivity reactions.

Conclusion: The most important PLT unit characteristic associated with TRAEs was PLT dose per transfusion. HD PLTs may increase the risk of TRAEs, and LD PLTs may reduce the risk.

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Conflict of interest statement

Conflicts of interest: Darrell J. Triulzi is on the medical advisory board for Fenwal Fresenius Kabi. Paul Ness is a consultant for TerumoBCT, Lakewood, CO. The remaining authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1. Frequency of Transfusion-Related Adverse Events (TRAEs)
Although seven PLT transfusions in the PLADO study were associated with a Grade 4 TRAE, all seven met one or more of the exclusion criteria for the TRAE analysis.
Fig. 2
Fig. 2. Multi-predictor logistic regression model for any TRAE vs. no TRAE
The odds ratios are adjusted for all other variables in the model, and for within-person correlation.
Fig. 3
Fig. 3. Multi-predictor logistic regression model for any TRAE of Grade 2 or higher vs. no TRAE of Grade 2 or higher
The odds ratios are adjusted for all other variables in the model, and for within-person correlation.
Fig. 4
Fig. 4. Multi-predictor logistic regression model for any fever TRAE vs. no fever TRAE
The odds ratios are adjusted for all other variables in the model, and for within-person correlation.
Fig. 5
Fig. 5. Multi-predictor logistic regression model for any allergic/hypersensitivity TRAE vs. no allergic/hypersensitivity TRAE
The odds ratios are adjusted for all other variables in the model, and for within-person correlation.

References

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