Tranexamic acid (TXA), a cost-effective and widely accessible medication, is commonly utilized in cardiac and orthopedic surgeries to minimize blood loss and red blood cell (RBC) transfusion. However, its application in other surgeries, particularly those with significant transfusion rates, remains uncertain. The primary goal of this study is to determine if implementing a hospital-level policy for routine TXA use in patients undergoing major non-cardiac surgeries can reduce RBC transfusions without heightening thrombotic risks.
Study Design and Methodology
This research is structured as a pragmatic, registry-based, blinded, cluster-crossover randomized controlled trial conducted across 10 Canadian sites. The trial includes patients undergoing non-cardiac surgeries with a high risk of RBC transfusion. The participating sites are randomized in four-week intervals to either a hospital policy of administering intraoperative TXA or a matching placebo. TXA is administered as 1 g at the skin incision, followed by an additional 1 g before skin closure.
The coprimary outcomes of the study are: the effectiveness, measured by the proportion of patients receiving RBC transfusions during their hospital stay, and the safety, assessed by the proportion of patients diagnosed with venous thromboembolism within 90 days post-surgery. Secondary outcomes include the number of RBC units transfused at both hospital and patient levels, in-hospital diagnoses of myocardial infarction, stroke, deep vein thrombosis, or pulmonary embolism, hospital length of stay, ICU admissions, hospital survival rates, 90-day survival, and the number of days alive and out of the hospital within 30 days.
Ethics and Dissemination
Ethical approval for the study has been obtained from the institutional research ethics boards at all participating sites. Upon the trial’s conclusion, a plain language summary of the results will be made available on the trial’s website and shared through the lay press. Additionally, the trial results will be published in a peer-reviewed scientific journal.
Key Inferences from the Study
- Routine use of TXA in major non-cardiac surgeries may significantly reduce the need for RBC transfusions.
- The study monitors potential thrombotic risks, ensuring patient safety within a 90-day postoperative period.
- The trial’s secondary outcomes offer insights into various aspects of patient care, including ICU admissions and overall survival rates.
The results from this trial are anticipated to provide concrete evidence on the efficacy and safety of TXA in non-cardiac surgeries, potentially influencing hospital policies and improving patient outcomes. This comprehensive approach seeks to address gaps in current medical practices and offer a broader application of TXA in surgical procedures.
Original Article: BMJ Open. 2024 Jun 3;14(6):e084847. doi: 10.1136/bmjopen-2024-084847.
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