Background

Following a concern raised to NHS England’s National Patient Safety Team regarding tranexamic acid use in gastrointestinal bleeding, and in light of the 2020 publication of the HALT-IT trial results, we are providing this position statement. Tranexamic acid (TXA) is an antifibrinolytic agent that inhibits the breakdown of fibrin clots by blocking plasminogen activation. Its efficacy in reducing bleeding and mortality has been demonstrated in trauma patients (CRASH-2) and in reducing bleeding in surgical patients.1 2 Systematic review of small older randomised trials in upper GI bleeding suggested that TXA might reduce mortality.3 However, these trials had methodological weaknesses and were conducted before routine use of modern therapies (such as proton-pump inhibitors and endoscopic haemostasis).4 The 2018 BSG guidelines on acute lower gastrointestinal bleeding recommended TXA use was confined to clinical trials, pending the HALT-IT trial results.5

The HALT-IT trial was a large, international, double-blind, placebo-controlled randomized controlled trial (n=12,009) comparing intra-venous TXA versus placebo in patients with significant upper or lower GI bleeding.6 There was no statistically significant reduction in the primary outcome of death due to bleeding within 5 days (3.7% in TXA arm vs 3.8% in placebo; risk ratio 0.99, 95% CI 0.82–1.18). The trial observed an increased risk of venous thromboembolism (0.8% in TXA group vs 0.4% in placebo; RR ~1.85, 95% CI 1.15–2.98) and seizures (0.6% vs 0.4%; RR ~1.73, 95% CI 1.03–2.93).

HALT-IT was a high-quality trial that avoided the methodological weaknesses of previous trials of TXA in GI bleeding, whose results are likely to be explained by bias.

Interpretation and BSG/ACPGBI position

Based on the evidence from the HALT-IT study, TXA should not be routinely used in acute upper or lower GI bleeding, given its lack of mortality benefit and safety concerns. Outside of a research context, if clinicians consider TXA use in truly exceptional circumstances where all conventional therapies have been exhausted, this must be a consultant gastroenterologist/gastrointestinal surgeon decision made with the patient and clearly documented as a use without established evidence of benefit. Use of TXA in acute GI bleeding in NHS hospitals should be reported and monitored within local governance frameworks, to ensure compliance with this position.