BACKGROUND AND PURPOSE:

• Tranexamic acid (TXA), an antifibrinolytic drug, has proven valuable in reducing bleeding-associated deaths due to trauma, postpartum hemorrhage, and traumatic brain injury
  • However, concerns remain regarding risk for vascular occlusive events
• Taeuber et al. (JAMA Surg., 2021) examined the association between IV TXA and total thromboembolic events (TEs) and mortality

METHODS:

• Systematic review and meta-analysis
• Data sources
  • Cochrane Central Register of Controlled Trials and MEDLINE between 1976 and 2020
• Study inclusion criteria
  • RCTs
  • Trials that compared IV TXA with placebo or no treatment
  • Excluded: Studies that administered only oral or topical TXA
• Primary outcomes
  • Vascular occlusive events
  • Mortality

RESULTS:

• 216 trials | 125,550 patients
• Total TEs
  • TXA: 2.1%
  • Control: 2.0%
• Dosing highly variable: From 0.5 to 5 g or 10 to 100 mg/kg
• There was no association between TXA and risk of TEs
  • Risk difference 0.001 (95% CI, −0.001 to 0.002; P=0.49)
• There was also no association between TXA and risk for
  • Venous thrombosis | PE | VTEs | Myocardial infarction or ischemia | Cerebral infarction or ischemia
• Administration of TXA
  • Was associated with reduction in overall mortality and bleeding mortality (both P<.001)
  • Was not associated with reduction in risk of nonbleeding mortality (P=.29)
• There was no increased risk of vascular occlusive events even in studies including patients with a history of thromboembolism
• There was no association between TXA and incidence of total TEs across studies with varying sample sizes
  • Sample size ≤99
    • Risk difference 0.004 (95% CI, −0.006 to 0.014; P=0.40)
  • Sample size 100 to 999
    • Risk difference 0.004 (95% CI, −0.003 to 0.011; P=0.26)
  • Sample size ≥1000
    • Risk difference −0.001 (95% CI, −0.003 to 0.001; P=0.44)
• There was no association between TXA dosing and risk for venous TEs
  • Risk difference −0.005 (95% CI, −0.021 to 0.011; P=0.53)

CONCLUSION:

• There is no association between IV TXA and increased risk for any thromboembolic events
  • This remained true even at different levels of TXA dosing and in studies of varying sample sizes
• TXA was associated with a reduction in risk of overall and bleeding-related mortality
• The authors conclude

Taken as a whole, this systematic review and meta-analysis did not find that intravenous treatment with TXA in patients of any medical discipline was associated with a significant increased risk for TEs irrespective of administered dose

Learn More – Primary Sources:

Association of Intravenous Tranexamic Acid With Thromboembolic Events and Mortality: A Systematic Review, Meta-analysis, and Meta-regression

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