This multi-center prospective, randomized controlled trial (RCT), which included nearly 1000 participants from the United States and Canada enrolled by paramedics, evaluated the use of tranexamic acid (TXA) administered in the field within two hours of traumatic brain injury (TBI), as well as its impact on long-term neurologic function in moderate or severe TBI patients.
The bottom line: there was no significant improvement in long-term neurologic recovery in those who received TXA compared with the control group.
Patients received either TXA or a placebo prior to hospital arrival. At six months post-injury, both groups had similar rates of favorable neurologic recovery; the difference between the groups was small and not statistically significant. In addition, mortality, disability ratings, and intracranial hemorrhage development were not significantly different between the groups.
In addition to demonstrating that higher doses of TXA may result in an increased rate of seizures, the researchers identified a number of key dosing and safety issues related to the administration of TXA. Overall, while TXA was safe in this study population, the results indicate that administering TXA to patients with suspected moderate or severe TBI without radiographic confirmation will not improve their outcome.
This trial provides additional evidence that administering TXA to TBI patients in the pre-hospital setting, based solely on clinical diagnosis, is not supported by the available data. The potential benefit of TXA may be more pronounced in specific patient subpopulations; therefore, further research should focus on identifying these subpopulations to develop better criteria for patient selection.
To access all of the trial’s methodology, subgroup analysis, dosing information, and how this trial relates to previous studies evaluating the use of TXA, including the CRASH-3 trial, please see the full article published in JAMA.
To read more publications from Dr. Martin Schreiber, visit his official website.
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