ABSTRACT
INTRODUCTION: Tranexamic acid (TXA) is one of the debated therapies in the management of traumatic brain injury (TBI). We conducted this study to evaluate the benefits of TXA in TBI on the mortality and its safety in these patients. METHODS: This was a prospective randomized open-label trial including all patients, aged at 18 years or older, hospitalized in the emergency room during a 13-month period, for TBI. After the realization of the body CT scan, the patients were included if they had intracranial bleeding, and were then randomized according to their medical file number to receive or not the TXA. The eligibility criteria were based on the uncertainty principle, patients with significant extracranial bleeding were excluded since there was evidence that TXA improve their outcome. RESULTS: We enrolled 180 patients aged at 42 ± 20 years, with an 88% men-proportion. Subarachnoid haemorrhage was the most frequent lesion in the brain CT-scan (67.5%). After randomization, 96 patients were in the TXA group (53%). Demographic data, clinical, biological and radiological features were statistically comparable in the two groups of patients ('TXA' and 'noTXA'). The needs of transfusion or neurosurgery, the mortality rate, the in-hospital length of stay and the dependency at 28-post-traumatic day were similar in the two groups of patients. However, pulmonary embolism was statistically more frequent in 'TXA' group (11.5 versus 2.4%, p = 0.02). CONCLUSION: TXA is an interesting treatment in haemorrhagic shock. Its efficiency in head trauma is still debated and controversial. Its impact on the mortality and the needs of transfusion or surgery were not demonstrated in this study. Nevertheless, its safety worth to be studied in larger samples as we found a higher rate of pulmonary embolism in the treated group.
