Table 3 Select Randomized Trials Studying Use of Tranexamic Acid
Title (Year published) | CRASH 2 (2010) | WOMAN (2017) | TICH-2 (2018) | CRASH 3 (2019) | STAAMP (2020) | HALT-IT (2020) | Prehospital TXA for TBIÂ (2021) |
|---|---|---|---|---|---|---|---|
Indication | Trauma patientswithin 8 hours of injury | Post-partum hemorrhage patients | Hemorrhagic stroke patientswithin 8 hours of symptom onset | TBI patients within 3 hours of injury | Hypotensive or tachycardic prehospital trauma patients | Upper or lower gastrointestinal bleeding patients | Severe TBI patients treated within 2 hours of injury |
Dosing of TXA | 1 g IV over 10 minutes, followed by 1 gm IV over 8 hours. | 1 g IV over 10 minutes. If bleeding continued,or resumed in 24 hours, a second 1 gm might be administered. | 1 g IV over 10 minutes, followed by 1 gm IV over 8 hours. | 1 g IV over 10 minutes, followed by 1 gm IV over 8 hours. | 1 g IV over 10 minutes, followed by either no further TXA, a second 1 g IV push, or a second 1 g IV over 8 hours. | 1 g IV over 10 minutes, followed by 3 gms IV over 24 hours, "high-dose, 24-hour infusion". | Randomized 1:1:1 to placebo; 1 g IV over 10 minutes, followed by 1 gm IV over 8 hours; or 2 g IV over 10 minutes, followed by placebo infusion over 8 hours. |
Number of patients | 20,127 | 20,060 | 2,325 | 12,737 | 903 | 12,009 | 966 |
Outcomes | All-cause mortality reduced by 1.5% in patients treated (RR 0.91) at any point. Mortality due to bleeding reduced 2.4% (RR 0.68) if treated in first hour. Mortality due to bleeding reduced 1.3% (RR 0.79) if treated between hours one and two. | Mortality trend of 0.4% less in all patients treated with TXA was not statistically significant (p = 0.045). But all-cause mortality in patients treated within three hours of giving birth reduced by 0.5% and was statistically significant (p = 0.008, RR = 0.69). | No difference in mortality or functional outcome at 90 days. But statistically significant decrease in hematoma size, and early survival, favoring TXA. | Non-statistically significant trend toward reduced mortality with TXA. In large subgroup of 5,615 mild to moderate injuries, a statistically significant mortality benefit of 1.7% (RR 0.78). | Non-statistically significant trend toward reduced 30-day mortality with TXA. In pre-planned subgroup analyses, patients treated within one hour saw a statistically significant mortality benefit of 3% (RR = 0.60, p < 0.002); patients with severe shock (SBP < 70 mm Hg) saw a statistically significant mortality benefit of 17% (18.5% vs 35.5%; RR = 0.52, p < 0.003). | No difference in mortality at 5 days. | No difference in mortality at 28 days, disability at 6 months, or progression of hemorrhage. |
Adverse Events | No increased risk of PE or DVT. In subset of patients who died from bleeding, increased risk of death among patients treated > 3 hours from time of injury. | No increased risk of PE or DVT. | No increased risk of PE or DVT. | No increased risk of PE or DVT. | No increased risk of PE or DVT. | 0.4% increased risk of PE or DVT with TXA. | No increased risk of PE or DVT. |