Studies examining the use of tranexamic acid (TXA) inescapably seem to pit our rigorous methodological demons against our practical clinical angels.

The CRASH-2 trial randomized 20,211 adult trauma patients presenting to 274 hospitals in 40 countries to receive 1 g of TXA over 10 minutes and an infusion of an additional 1 g over eight hours or matching placebo.

The authors found a 1.5% absolute difference in their primary outcome, in-hospital mortality at 28 days.

But questions about the trial’s external validity arose because many of the sites enrolling patients did not have modern trauma systems.

Do the benefits of TXA remain if hemorrhage control is achieved rapidly? This question remains unanswered nine years after the publication of CRASH-2.

This trial was a massive undertaking, one that we are unlikely to see validated in a modern trauma system.

We are tasked with deciding whether to accept its observed benefits or whether the methodological shortcomings invalidate its findings.

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