In patients with isolated severe traumatic brain injury (TBI), preclinical treatment with tranexamic acid may increase risk mortality, according to study results published in JAMA Neurology.
Severe TBI is a leading cause of trauma-related mortality and disability. The study’s researchers wanted to find out whether preclinical tranexamic acid administration was related to mortality and functional outcomes in patients with TBI.
This study was a retrospective analysis of prospectively collected observational data from the BRAIN-PROTECT (BRAIN-PROTECT) study conducted in the Netherlands to investigate the outcomes, treatments, and epidemiology of brain trauma. The study researchers analyzed data for patients treated for suspected severe TBI between 2012 and 2017. They tracked patients and collected hospital data and results for up to 1 year after admission.
The researchers analyzed the association between preclinical treatment with tranexamic acid and 30-day mortality. They also rated 1-year mortality, functional neurological recovery at discharge on the Glasgow Outcome Scale, and length of hospital stay.
A total of 1827 patients with suspected TBI were included in this analysis (mean age 45 years; men 70%). A significantly higher 30-day mortality was found in the adjusted analysis of patients treated with preclinical tranexamic acid (odds ratio) [OR]1.34; 95% CI, 1.16-1.55; P <0.001) compared to patients who were not treated with tranexamic acid prior to hospitalization. This association was valid for under-analyzes of patients with confirmed TBI (OR 1.34; 95% CI 1.15-1.56; P <0.001) and for patients with isolated TBI (OR 1.74; 95% CI 1.33- 2.27; P <0.001).
In the potential confounder-adjusted analysis, there was no association between hospital tranexamic acid treatment and mortality TBI across the study cohort and in patients with confirmed TBI, but the likelihood of 30-day mortality in patients with isolated severe disease was increased TBI treated with preclinical tranexamic acid (OR 4.49; 95% CI 1.57-12.87; P = 0.005). This association persisted after several imputations, but was not as pronounced (OR 2.05; 95% CI 1.22-3.45; P = 0.007).
The limitations of the study included the lack of a causal relationship analysis between hospital tranexamic acid use and mortality, and the possible residual confounders that were not considered in the final analyzes.
The researchers finally concluded that their study results “[suggest] This administration of tranexamic acid should be avoided “in patients with isolated severe TBI.
Disclosure: Several authors of the study have stated that they are part of the pharmaceutical industry. For a full list of the authors’ information, see the original reference.
Bossers SM, Loer SA, Bloemers FW et al. Association between pre-hospital tranexamic acid administration and outcomes of severe traumatic brain injury. JAMA Neurol. Published online 7 December 2020. doi: 10.1001 / jamaneurol.2020.4596