Introduction: The aim of this meta-analysis was to assess whether tranexamic acid (TXA) therapy for adult cardiac surgery is associated with an increase in the risk of seizures, and we performed a meta-analysis of randomized controlled trials (RCTs) and non-randomized observational studies.
Evidence acquisition: MEDLINE and EMBASE were searched through December 2016 using PubMed and OVID. Eligible studies were RCTs and non-randomized observational studies on TXA versus control (no TXA, placebo, or active control such as low-dose TXA, aprotinin, and epsilon aminocaproic acid) enrolling adult patients undergoing cardiac surgery and reporting the postoperative incidence of seizures as an outcome. Study-specific estimates were combined using inverse variance-weighted averages of logarithmic odds ratios (ORs) in the random-effects model.
Evidence synthesis: Of 90 potentially relevant articles screened initially, 16 reports of eligible studies were identified and included. A pooled analysis of all 16 studies (enrolling 45,235 patients) demonstrated that TXA therapy was associated with a statistically significant increase in the seizures incidence (OR=4.13; 95% CI: 2.59 to 6.57; P<0.00001). A subgroup analysis indicated a statistically significant increase in the seizures incidence with TXA therapy in all subgroups of 5 RCTs, 5 adjusted observational studies, and 6 unadjusted observational studies with no statistically significant subgroup differences (P=0.36; I2=1.5%).
Conclusions: The results of the present meta-analysis of 16 studies enrolling 45,235 patients confirmed that TXA therapy for adult cardiac surgery is associated with a 4.1-fold increase in the risk of seizure.