Warning: An American on TXA.
The WOMAN trial was an international randomized double-blind placebo controlled trial across 193 hospitals in 21 countries looking at TXA use for morbidity and mortality for post-partum hemorrhage.
First off, this was a massive undertaking as this was an enormous trial – about 10,000 patients in each treatment arm, with fantastic follow up- only 31 of about 20,060 total patients were lost to follow up. If the treating provider was unclear as to the utility of TXA for post-partum hemorrhage control, the patient was randomized 1:1 to placebo or 1g of TXA, and if the bleeding continued after 30 min or stopped and restarted within 24 hours of the first dose, a second dose (1g TXA) or placebo was given. Baseline characteristics were quite similar between the placebo and TXA arms.
So since social media is clamoring, and since this is published in the Lancet, there must be a mortality benefit, right?
This is where I point out three things:
1) there was no difference in mortality (2.3% vs 2.6% – favoring placebo)
2) TXA had 0.4% fewer patients who experienced death due to post-partum hemorrhage
3) this was accompanied by a p value of 0.045, and a fragility index of…..
A study of 20,000+ patients, and a p-value of 0.045, and a fragility index of zero. And again, the most patient-centered outcome possible- mortality – favored placebo.
TXA is not the magic bullet in this instance. There is a weak signal of benefit if you are proceeding to laparotomy for bleeding – particularly for caesaean delivery (1.5% vs 2.4% mortality benefit, fragility index of 4), but that is an exploratory analysis needing further review, otherwise, this is a flimsy trial. While TXA remains inexpensive, it is worth a go- particularly in low-resource areas after laparotomy (provided TXA is still inexpensive there), but by no means does a clinician not giving it deserve to be chided – the evidence is incredibly fragile and not worthy of social media’s “life-saving” claims – at least for post-partum hemorrhage.
EM in Focus 