Abstract
Transfusion Service
Magali J. Fontaine, MD, PhD (she/her/hers)
Professor of Pathology and Medicine and Medical Director
University of Maryland School of Medicine, Maryland, United States
Disclosure(s): No financial relationships to disclose
Cardiac surgery on cardiopulmonary bypass (CPB) commonly results in bleeding due to altered platelet (PLT) function and then requires PLT transfusion. In order to mitigate the risk of transfusion transmitted infections (TTI), PLT components may be treated with pathogen reduction technology (PRT). The goal of the current study is to evaluate the hemostatic effect of PRT-PLTs compared to untreated PLTs stored in platelet additive solution (PAS) following transfusion in bleeding patients undergoing cardiac surgery on CPB.
Study
Design/Methods: In this single-center, prospective single-blinded two-arm noninferiority trial, patients being weaned off CPB were allocated to receive either a PRT-PLT or a standard PAS-PLT. The primary outcome was the change in maximum amplitude (ΔMA) on thromboelastographic testing (TEG) from pre- to post-transfusion. The non-inferiority margin was chosen as 50% of the ΔMA observed with PAS-PLT using a 1-sided 95% confidence interval. The secondary outcomes included the volume of chest tube drainage (CTD) and the number of blood products transfused during the first 24 hours post-surgery.
Results/Findings: A modified intention-to-treat analysis included 90 patients (48 PRT-PLTs; 42 PAS-PLTs). Groups were well balanced except for number of male patients 27 (64.3%) in the PRT group and 42 (87.5%) in the PAS group. The ΔMA for PRT-PLT was 2.96 mm (95% CI 1.50 – 4.41) and was significantly lower than that achieved with PAS-PLT at 5.54 mm (95% CI 2.97 – 8.12 ) (2-tailed P=0.009). The ratio of ΔMA for PRT-PLT relative to PAS-PLT was estimated at 0.53 with 90% confidence interval (0.24, 0.83). Thus, the ratio of ΔMA for PRT-PLT did not meet the non-inferiority criterion ( >0.5) when compared with PAS-PLT. Overall, the CTD and the number of blood products transfused during the first 24 hours post-surgery per category were similar in both arms (p=0.331 for CTD; p=0.446 for Red blood cells; p=0.580 for plasma; p=0.421 for cryoprecipitate).
Conclusions:
From these data, the investigators cannot conclude that the PRT-PLT is non-inferior to PAS-PLT for correction in MA after PLT administration. PRT-PLT may result in lower responses in viscoelastic testing compared to PAS-PLT, although clinical outcomes with respect to blood component utilization and chest tube drainage were similar.