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19th June 2023
Tranexamic acid (TXA) use before admission to hospital in patients with major trauma and suspected trauma-induced coagulopathy, fails to improve survival and favourable outcomes after six months compared to placebo, according to the findings of a recent randomised trial.
Trauma-induced coagulopathy describes the abnormal blood clotting processes attributable to trauma and is an independent predictor of mortality. It has been suggested that antifibrinolytic drugs such as TXA could reduce mortality in trauma patients with bleeding. While some data support the use of early TXA to reduce risk of death in such patients, other works indicate no survival advantage for the drug.
In trying to provide more clarity on the potential value of early use of TXA, the current study, published in the New England Journal of Medicine, was a randomised, placebo-controlled trial of pre-admission TXA in trauma patients with suspected trauma-induced coagulopathy.
Participants were randomised to either an intravenous one gram bolus dose of TXA before hospital admission, with a second dose infused over eight hours once in hospital, or matching placebo. Eligible patients were adults with suspected severe traumatic injuries, assessed as being at a high-risk for trauma-induced coagulopathy and where the first dose of TXA or placebo could be administered within three hours of their injury prior to hospital admission.
The primary outcome was survival, with a favourable functional outcome six months after their injury. This was assessed using the Glasgow Outcome Scale-Extended (GOS-E), which ranges from one (death) to eight (no injury-related problems). Researchers defined a favourable outcome as a GOS-E score of five or more. Secondary outcomes included death from any cause within 28 days and within six months post-injury.
A total of 1,310 patients were included, of whom 661 were assigned to receive TXA.
There was no difference in the primary outcome. Survival with a favourable functional outcome at six months occurred in 53.7% in the tranexamic acid group and in 53.5% in the placebo group (risk ratio, RR = 1.00, 95% CI 0.90 – 1.12, p = 0.95). Some 28 days after their injury, significantly fewer patients given TXA had died (RR = 0.79, 95% CI 0.63 – 0.99). However, this difference became non-significant after six months (RR = 0.83, 95% CI 0.67 – 1.03). Furthermore, the number of serious adverse events did not differ meaningfully between the groups.
The researchers calculated that for every 100 patients treated with TXA rather than placebo, there were approximately four extra patients alive at six months but approximately four extra were also categorised as having severe disability.