Background
Previously, the effect of early tranexamic acid (TXA) infusion has been reported inconclusively in patients with trauma hospitalized in developed countries. We aimed to investigate the effectiveness and side effects of TXA infusion in patients with trauma.
Method
The present study was a blinded parallel-designed randomized clinical trial (RCT) on 140 patients with trauma. The first group (n = 70) received early TXA(1 g/stat, for 10 min) and the second group (n = 70) received normal saline as placebo. Needing blood infusion and surgical procedures, the number of needed pack cells, thrombosis and mortality were compared between the two groups.
Results
No difference has been shown in outcomes between the two groups. Men required 41.1 times more blood transfusion than women (p = 0.01). Coincidence of pneumothorax and abdominal injury increased the blood requirement by 7.6 and 26.3 times, respectively (p = 0.002 and p = 0.005). The TXA group required 1.9 times more blood transfusions than the placebo. Men showed a 3.9 times higher risk of venous thrombosis than women. Also, patients who had trauma and pneumothorax had a 2.87 times higher risk of venous thrombosis. Abdominal trauma and organ fractures increased the risk of venous thrombosis by 2.5 and 2.2 times, respectively. In addition, the risk of venous thrombosis was 62% lower in the TXA than in the placebo.
Conclusion
The sex of patients and co-morbidities along with trauma affected the blood requirements. Men and patients with co-morbidities are more susceptible to the venous thrombosis, adjusting for grouping. Further studies with larger sample sizes are needed to confirm these results.
Trial registration
The present study has been registered in the Iranian randomized clinical trials under the number of IRCT20220507054758N1 that is submitted on 24 May 2022.
