Meta-analysis of the randomized controlled trials of the hemostatic efficacy and capacity of pathogen-reduced...

A recent independently funded randomized controlled trial (RCT; Br J Haematol 2010;150:209-17) questioned prevailing opinion concerning the hemostatic capacity of pathogen-reduced platelets (PLTs). Meta-analysis was used to calculate the effect of pathogen reduction (PR) of PLTs on hemostatic efficacy and capacity based on all available data and to investigate possible reasons for the variation in reported findings.

RCTs allocating patients to receive routine PLT transfusions with pathogen-reduced or untreated PLTs and reporting on at least one of six hemostasis endpoints were eligible for analysis. Five RCTs of hemato-oncology patients met eligibility criteria. Endpoints determined by similar criteria in all RCTs were integrated by fixed-effects methods. Endpoints determined by different criteria were integrated by random-effects methods.

Studies were statistically homogeneous in all analyses. Pathogen-reduced PLTs were associated with a significant (p < 0.05) reduction in 1- and 24-hour posttransfusion corrected count increments (summary mean difference, 3260; 95% confidence interval [CI], 2450-4791; and summary mean difference, 3315; 95% CI, 2027-4603) as well as a significant increase in all and in clinically significant bleeding complications (summary odds ratio [OR], 1.58; 95% CI, 1.11-2.26; and summary OR, 1.54; 95% CI, 1.11-2.13). The frequency of severe bleeding complications did not differ.

The results of the recent RCT are not inconsistent with those of the earlier studies. Introduction of PR technologies in their current stage of development would result in an increase in mild and moderate (albeit not severe) bleeding complications, which the transfusion-medicine community must explicitly tolerate to reap the benefits from PR.