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Exclusion criteria and adverse events in perioperative trials of tranexamic acid in cardiac surgery: a systematic review and meta-analysis

Faculty of Medicine, University of Ottawa, Ottawa, Canada. Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Canada. Ottawa Hospital, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada. Faculty of Medicine, University of Ottawa, Ottawa, Canada. esaidenberg@toh.ca. Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Canada. esaidenberg@toh.ca. Ottawa Hospital, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada. esaidenberg@toh.ca.

Canadian journal of anaesthesia = Journal canadien d'anesthesie. 2019
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Abstract
PURPOSE Tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement following cardiac surgery. Nevertheless, TXA remains underutilized because of concerns regarding development of adverse events. We conducted a systematic review to determine which patients are commonly excluded from TXA cardiac surgery clinical trials to determine if there are patient groups lacking safety data on TXA. METHODS The databases Medline, EMBASE, and the Cochrane Central Register of Controlled Trials were searched until September 2017. Eligible studies were randomized-controlled trials (RCTs) administering systemic TXA perioperatively to patients undergoing any cardiac surgery. Our primary outcome was the exclusion criteria for each RCT, and the secondary endpoint was TXA safety. A descriptive synthesis was performed to analyze the exclusion criteria. TXA safety was assessed with meta-analysis. PRINCIPAL FINDINGS Seventy eligible RCTs were included. The most common reasons for excluding patients from TXA cardiac surgery trials were major hepatic, renal, or cardiac comorbidities (76% of studies). Meta-analysis showed that TXA did not increase the risk of adverse events compared with placebo or no intervention (risk ratio, 0.97; 95% confidence interval, 0.88 to 1.07), including thrombosis and seizure. CONCLUSION We found that systemic TXA is safe to use in cardiac surgery. Certain patient groups are frequently excluded from TXA cardiac surgery trials, and may consequently have limited efficacy and safety data on TXA. Further research in these patient groups may be needed; nevertheless, for many patient populations there are sufficient data to inform evidence-based guidelines for TXA use in cardiac surgery. TRIAL REGISTRATION PROSPERO (CRD42017060971); registered 4 April, 2017.
Study details
Study Design : Systematic Review
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine