Category: Critical Care
Keywords: gastrointestinal bleeding, TXA (PubMed Search)
Posted: 7/30/2020 by Lindsay Ritter, MD
(Updated: 8/4/2020)
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Prior to this study, a Cochrane review and meta-analysis of TXA for upper GI bleeds with 7 trials (1654 patients), showed a large reduction in mortality with TXA (RR 0.61, 95% CI 0.42-0.98, p=0.01)
Design:
-Randomized, international, multicentre, placebo-controlled trial at 164 hospitals in 15 countries Juy 2013-2019
->16/18 years old with upper or lower GI bleeding
-1 g TXA IV over 10 minutes followed by maintenance dose 3 g TXA over 24 hours
Results:
-Main outcome death due to bleeding within 5 days
-4% (222/5994) died in TXA group vs 4% (226/5981) placebo risk ratio RR 0.99, 95% CI 0.82-1.18
-Arterial thromboembolic events MI/CVA similar in both groups (0.7% vs 0.8%)
-Venous thromboembolic events PE/DVT higher in TXA group (0.8% vs 0.4%)
Pitfalls:
-Initially calculated all cause mortality until realization that over half deaths were due to non-bleeding causes, changed to death related to bleeding, allowing study appropriate power to detect difference
-Majority of patients had UGIB/variceal bleeding due to liver disease, over 75% deaths in those with liver disease
-Only 16% patients randomized in <3 hours, most >8 hours (CRASH-2 trial found benefit TXA in trauma patients only <3 hrs to administration)
Takeaway:
-TXA should not be used in the management of GI bleeds
-Increased venous thromboembolic events associated with TXA administration for GI bleeds
HALT-IT Trial Collaborators. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi:10.1016/S0140-6736(20)30848-5
Gluud LL, Klingenberg SL, Langholz E. Tranexamic acid for upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2012;1
