Association of Intravenous Tranexamic Acid with Thromboembolic Events and Mortality - A Systematic Review
Journal of the American Medical
Association (JAMA)
Surgery
Tranexamic
acid is an antifibrinolytic compound which inhibits fibrinolysis by blocking
the binding of plasminogen and plasmin to fibrin, thus preventing dissolution
of the haemostatic plug.
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Question Is intravenous administration of tranexamic acid associated with thromboembolic events in patients of all ages and of any medical discipline?
Findings In this systematic review and meta-analysis of 216 studies of 125 550 patients undergoing surgical procedures and receiving either intravenous administration of tranexamic acid or placebo or no treatment, 1020 (2.1%) thromboembolic events in the tranexamic acid group and 900 (2.0%) total thromboembolic events in the control group were found. There was no increased risk of any thromboembolic event in patients of all medical disciplines.
Meaning These results clarify whether vascular occlusive events are associated with administration of tranexamic acid.
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Importance
Tranexamic acid (TXA) is an efficient antifibrinolytic agent; however, concerns remain about the potential adverse effects, particularly vascular occlusive events that may be associated with its use.
Objective
To examine the association between intravenous TXA and total thromboembolic events (TEs) and mortality in patients of all ages and of any medical disciplines.
Data Source
Cochrane Central Register of Controlled Trials and MEDLINE were searched for eligible studies investigating intravenous TXA and postinterventional outcome published between 1976 and 2020.
Study Selection
Randomized clinical trials comparing intravenous TXA with placebo/no treatment. The electronic database search yielded a total of 782 studies, and 381 were considered for full-text review. Included studies were published in English, German, French, and Spanish. Studies with only oral or topical tranexamic administration were excluded.
Data Extraction and Synthesis
Meta-analysis, subgroup and sensitivity analysis, and meta-regression were performed. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.
Main Outcomes and Measures
Vascular occlusive events and mortality.
Results
A total of 216 eligible trials including 125 550 patients were analyzed. Total TEs were found in 1020 (2.1%) in the group receiving TXA and 900 (2.0%) in the control group. This study found no association between TXA and risk for total TEs for venous thrombosis, pulmonary embolism, venous TEs, myocardial infarction or ischemia, and cerebral infarction or ischemia.
Conclusions and Relevance
Findings from this systematic review and meta-analysis of 216 studies suggested that intravenous TXA, irrespective of dosing, is not associated with increased risk of any TE. These results help clarify the incidence of adverse events associated with administration of intravenous TXA and suggest that TXA is safe for use with undetermined utility for patients receiving neurological care.
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