Administering tranexamic acid (TXA) in hospitals has been shown to improve outcomes for patients at risk of hemorrhage following injuries. However, there’s been limited research on the effectiveness and safety of using TXA in pre-hospital settings, specifically during patient transport. A recent study aimed to address this gap by investigating the use of TXA before hospitalization for injured patients.
This study was a robust, phase 3, multicenter, double-blind, placebo-controlled clinical trial conducted across four Level 1 trauma centers in the US. Researchers enrolled injured patients who exhibited pre-hospital hypotension (systolic blood pressure ≤90 mm Hg) or tachycardia (heart rate ≥110/min) – indicators of potential hemorrhage. These patients were enrolled within an estimated 2 hours of their injury, spanning from May 2015 to October 2019. A total of 903 patients were ultimately included in the analysis, randomly assigned to receive either 1 gram of TXA or a placebo, administered intravenously over 10 minutes in a pre-hospital setting.
The primary outcome assessed was 30-day all-cause mortality. The study found that while there was a lower mortality rate in the TXA group (8.1%) compared to the placebo group (9.9%), this difference was not statistically significant (P = .17). Specifically, randomization to pre-hospital TXA did not show a significant reduction in 30-day mortality (hazard ratio, 0.81; 95% CI, 0.59-1.11, P = .18).
However, further analysis revealed crucial insights. Pre-specified dosing regimens and post-hoc subgroup analyses indicated that pre-hospital TXA administration was linked to significantly lower 30-day mortality in certain patient subgroups. Notably, when considering the time to treatment, patients who received TXA within 1 hour of injury showed a significant reduction in 30-day mortality (4.6% vs 7.6%; difference, -3.0%; 95% CI, -5.7% to -0.3%; P < .03).
The study’s findings suggest that while pre-hospital TXA may not significantly reduce overall 30-day mortality in all injured patients at risk of hemorrhage, it is a safe intervention. Importantly, the administration of TXA in the pre-hospital setting did not lead to an increased incidence of thrombotic complications or adverse events. Moreover, the data indicates a potential survival benefit for specific subgroups, particularly when TXA is administered rapidly, within the first hour after injury. This highlights the critical importance of timely intervention in trauma care and suggests that pre-hospital TXA administration during patient transport can be a valuable tool for improving outcomes in time-sensitive situations.
In conclusion, this study provides evidence that pre-hospital TXA administration in injured patients during transport is safe and may offer survival advantages for specific patient groups, especially when administered early after injury. These findings are significant for emergency medical services and protocols related to the transport of trauma patients, emphasizing the potential benefits of incorporating pre-hospital TXA into early hemorrhage management strategies.
