Abstract | BACKGROUND: The eligibility criteria of a previously reported meta-analysis (Transfusion 2011;51:1058-1071) 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 ≥10×10(9) or ≥20×10(9)/l through increased platelet transfusions.
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Authors | E C Vamvakas |
Journal | Vox sanguinis
(Vox Sang)
Vol. 102
Issue 4
Pg. 302-16
(May 2012)
ISSN: 1423-0410 [Electronic] England |
PMID | 21957897
(Publication Type: Journal Article, Meta-Analysis)
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Copyright | © 2011 The Author(s). Vox Sanguinis © 2011 International Society of Blood Transfusion. |
Topics |
- Blood Platelets
(microbiology)
- Disease Transmission, Infectious
(prevention & control)
- Hemorrhage
(etiology)
- Humans
- Platelet Transfusion
(adverse effects)
- Randomized Controlled Trials as Topic
(standards)
- Thrombocytopenia
(blood)
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