Meta-analysis of the studies of bleeding complications of platelets pathogen-reduced with the Intercept system

Background The eligibility criteria of a previously reported meta-analysis (Transfusion 2011;51:10581071) of randomized controlled trials (RCTs) of pathogen reduction of platelets in patients with hypoproliferative thrombocytopenia were modified to examine the impact on the findings of: (1) inclusion of a (previously excluded) RCT; (2) restriction of eligibility to RCTs of the Intercept (amotosalen-HCl/ultraviolet-A-light) system; and (3) differences in the methods used to assess bleeding complications. Materials and Methods Five RCTs comparing the risk of all, clinically significant (grades 2 through 4) and / or severe (grades 3 and 4) bleeding complications between recipients of platelets treated with Intercept vs. standard unmanipulated platelets were included. Odds ratios (ORs) of bleeding complications of similar severity recorded during similar periods of observation were calculated across all studies and across homogeneous subsets of studies by random- effects methods. Results Treatment with Intercept increased all bleeding complications when four RCTs meeting the eligibility criteria of the previous meta- analysis were integrated, but not across all the five currently available studies [ summary OR = 1 24; 95% confidence interval (CI), 0 79- 1 93]. Clinically significant bleeding complications increased when the results of the SPRINT RCT were based on the expanded safety analysis (summary OR = 1 52; 95% CI, 1 09- 2 12) - but not the initial report (summary OR = 1 30; 95% CI, 0 54- 3 14) - of that study. Conclusions Treatment with Intercept may increase the risk of all and clinically significant (albeit not severe) bleeding complications in RCTs maintaining a platelet count of 10 u 10 9 or 20 u 10 9 / l through increased platelet transfusions.