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Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis
Katharine Ker1, Phil Edwards, Pablo Perel
1Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK. katharine.ker@lshtm.ac.uk
Insights
Tranexamic acid significantly reduces the need for blood transfusions in surgical patients, with strong evidence available for over a decade. Its effects on thromboembolic events and mortality remain uncertain, requiring patient awareness for informed choices.
Area of Science:
- Medical research
- Clinical trials
- Evidence-based medicine
Background:
- Tranexamic acid is an antifibrinolytic medication.
- Its use in surgery aims to reduce bleeding.
- The impact on transfusion needs, thromboembolic events, and mortality requires comprehensive assessment.
Purpose of the Study:
- To systematically review and meta-analyze the effects of tranexamic acid in surgical patients.
- To evaluate its impact on blood transfusion requirements.
- To assess its influence on thromboembolic events and patient mortality.
Main Methods:
- Systematic review and meta-analysis of 129 randomized controlled trials.
- Inclusion of 10,488 surgical patients from 1972 to 2011.
- Data sources included major medical databases and trial registries.
Main Results:
- Tranexamic acid reduced the likelihood of blood transfusion by one-third (RR 0.62, P<0.001).
- Evidence for reduced mortality was observed (RR 0.61, P=0.04), but with uncertainty in high-quality trials.
- The effects on myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism were uncertain.
Conclusions:
- There is robust evidence that tranexamic acid effectively reduces blood transfusions in surgery.
- Further research on transfusion reduction is unlikely to yield new insights.
- The impact on thromboembolic events and mortality requires further investigation, necessitating informed patient consent.
Objective:
To assess the effect of tranexamic acid on blood transfusion, thromboembolic events, and mortality in surgical patients.
Design:
Systematic review and meta-analysis.
Data Sources:
Cochrane central register of controlled trials, Medline, and Embase, from inception to September 2011, the World Health Organization International Clinical Trials Registry Platform, and the reference lists of relevant articles.
Study Selection:
Randomised controlled trials comparing tranexamic acid with no tranexamic acid or placebo in surgical patients. Outcome measures of interest were the number of patients receiving a blood transfusion; the number of patients with a thromboembolic event (myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism); and the number of deaths. Trials were included irrespective of language or publication status.
Results:
129 trials, totalling 10,488 patients, carried out between 1972 and 2011 were included. Tranexamic acid reduced the probability of receiving a blood transfusion by a third (risk ratio 0.62, 95% confidence interval 0.58 to 0.65; P<0.001). This effect remained when the analysis was restricted to trials using adequate allocation concealment (0.68, 0.62 to 0.74; P<0.001). The effect of tranexamic acid on myocardial infarction (0.68, 0.43 to 1.09; P = 0.11), stroke (1.14, 0.65 to 2.00; P = 0.65), deep vein thrombosis (0.86, 0.53 to 1.39; P = 0.54), and pulmonary embolism (0.61, 0.25 to 1.47; P=0.27) was uncertain. Fewer deaths occurred in the tranexamic acid group (0.61, 0.38 to 0.98; P = 0.04), although when the analysis was restricted to trials using adequate concealment there was considerable uncertainty (0.67, 0.33 to 1.34; P = 0.25). Cumulative meta-analysis showed that reliable evidence that tranexamic acid reduces the need for transfusion has been available for over 10 years.
Conclusions:
Strong evidence that tranexamic acid reduces blood transfusion in surgery has been available for many years. Further trials on the effect of tranexamic acid on blood transfusion are unlikely to add useful new information. However, the effect of tranexamic acid on thromboembolic events and mortality remains uncertain. Surgical patients should be made aware of this evidence so that they can make an informed choice.
