A prospective non-inferiority trial of pathogen reduced platelets compared to non-pathogen reduced platelets for correction of viscoelastic platelet function testing in cardiac surgery
Abstract
Background
Cardiac surgery on cardiopulmonary bypass (CPB) may alter platelet (PLT) function causing bleeding. The goal of this 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.
Methods
In this single-center, prospective single-blinded two-arm noninferiority trial, patients being weaned off CPB were allocated to 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 h post-surgery.
Results
A modified intention-to-treat analysis included 90 patients (48 PRT-PLTs; 42 PAS-PLTs). The ΔMA for PRT-PLT was 2.93 mm (95% CI 1.52–4.34) and was lower than that achieved with PAS-PLT at 5.68 mm (95% CI 3.26–8.09) (2-tailed p = .052). The ratio of ΔMA for PRT-PLT relative to PAS-PLT was estimated at .52 with a 90% confidence interval (.29, .89) and did not meet the non-inferiority criterion (>.5). The CTD and the number of blood products transfused during the first 24 h post-surgery were similar in both arms.
Conclusion
PRT-PLT transfusion results 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.